Aimovig versus salt

Aimovig™: A Miracle Migraine Treatment or Unnecessary Risk?

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On July 31, 2018, the Daily Mail of London wrote about the Stanton Migraine Protocol and how a simple dietary change can help prevent migraines. The journalist became curious about the topic because a migraineur gave a testimonial about this protocol on YouTube. The paper started off with:

The conventional advice — backed by everyone from the NHS to the British Heart Foundation and the Scientific Advisory Committee on Nutrition — is to reduce salt intake where possible, owing to its links with high blood pressure, heart disease and stroke.

The official guidance is that we should eat no more than 6g of salt a day, which is around a teaspoonful. But Tracey, from Stretford, near Manchester, is one of a growing number of people following a controversial plan devised by a U.S. neuroscientist which involves eating twice that amount — with occasional extra scoops of ‘emergency salt’ — in a bid to keep migraines at bay

Thus, the topic of taking extra salt was critically viewed as a recognized health concern. The same article concluded:

However, there is now a preventive drug specifically developed for migraine called Aimovig.’ This has just been approved by the European Medicines Agency and ‘should soon be on prescription from GPs’.

The Migraine Trust advises consulting a GP first if you are considering consuming more salt.

Let me spell out what these quotes demonstrate exactly. Currently, most medical professionals consider taking a brand-new drug safer than taking of a bit of extra salt.

Salt and Health

Salt is in every human cell taking up about 0.4% of the body’s weight and is an essential mineral for survival. We lose salt by sweating, talking, breathing, and by our internal toxin removal processes making daily salt consumption essential for remaining healthy. The 6 gr salt amount recommendation by the above mentioned agencies and the USDA has been debated to be too low for health for years. For instance, an article in the academic journal The Lancet found that about 10 gr salt (4 gr sodium) is the ideal amount for those with heart events and even more for those whose hearts are healthy1. It also shows that at 3 gr salt (1.2 gr sodium) or less per day, an individual’s health takes an exponential turn for the worse and fatalities may occur. A Headache journal article found that there is an inverse relationship between salt consumption amount and migraine—meaning increased dietary sodium reduces the occurrences of migraines2.

I have yet to see the claim “essential” placed on a medicine, yet without hesitation many medical professionals view medicines a safer option than an essential mineral we must consume every day.

Medicinal Migraine Treatments

Migraine is a very painful and disabling condition that about 15% of the population endures, often daily, for many years. Up until now, there have been no migraine preventive medications on the market and migraine sufferers are prescribed a host of dangerous medications, cocktails of them, originally intended for other health conditions.

  • Anticonvulsants (anti-seizure medications)—Topamax, Neurontin, or Lyrica;
  • Tricyclic antidepressants (simple serotonin)—Amitriptyline or Nortriptyline;
  • SSRIs (selective serotonin reuptake inhibitors)—Lexapro or Zoloft;
  • Beta blockers or ACE inhibitors—Propranolol or Toprol;
  • Opiates—codeine, fentanyl, hydrocodone;
  • Anti-inflammatory—Corticosteroids;
  • NSAIDs—Celebrex;
  • Triptans—Imitrex, Frova, Maxalt, etc.;

The universal complaint from migraineurs across the board is that none of these medicines works and that they have debilitating side effects. Will Aimovig™ be different and help migraineurs? And, more importantly, will it be safe?

Aimovig™

Aimovig™ (AMGEN, Novartis) was approved by the FDA as the first migraine preventive medicine on May 17, 2018. The medicine is a CGRP receptor agonist. CGPR stands for Calcitonin Gene-Related Peptide Receptor. Calcitonin gene-related peptides have major roles in the central nervous system (CNS) and throughout the body. CGRP is a protein that modulates a variety of physiological functions, such as respiratory, endocrine, gastrointestinal, immune, and cardiovascular function. CGRP also affects the thyroid. Calcitonin acts to reduce blood serum calcium, and thus blocking it, would likely increase serum calcium. The increase in serum calcium is undesired. Too much calcium in the blood can weaken bones, and participates in atherosclerosis, which is the calcification of the arteries, causing hardening—this is referred to as coronary artery calcification.

Some nerve blockers, like Botox, have been demonstrated to block CGRP as well. CGRP modulates cyclic adenosine monophosphate cAMP, a messenger that is important in many biological processes. It is a derivative of ATP and used for intracellular signaling. CGRP is a potent hypotensive peptide—it is a vasodilator3.

CGRP blockers work by reducing stimulus that would reach nociception. Nociceptors detect noxious or harmful stimuli everywhere in the body and signal this stimulus by pain. Aimovig™ specifically targets nociceptors and prevents them from discovering harmful stimuli.

In some conditions, excitation of pain fibers becomes greater as the pain stimulus continues, leading to a condition called hyperalgesia” (see here).

Hyperalgesia means that the receptors become increasingly sensitive to pain over time (see here). For example, opioid-induced hyperalgesia may develop as a result of long-term opioid use4. This suggests that long term use of Aimovig™ may also induce hyperalgesia. This was not studied in the clinical trial. CGRP blocking may pose a risk in subjects with comorbidities such as cardiovascular diseases.

It is important to recall how SSRIs work (see my previous article on how inhibitory systems can cause life threatening health conditions by permanently blocking channels), because it appears that Aimovig™ acts similarly. A journal article describes the findings on Aimovig™ (there labelled as Erenumab/AMG334) alongside with other anti-CGRP monoclonal antibody trials by other pharmaceuticals. The research data of the clinical trial was released to the scientific community with an appendix providing the details. one can also get a pretty good idea of the information the FDA considered or received to be considered from the FDA label and from descriptions of competing products for which the information was released5,6.

Aimovig™—The Label

At the Aimovig™’s website, there is a video of slide presentation for healthcare professionals, from which I created a transcript. You can find the slides on this page.

  • CGRP signaling plays a key role in migraine pathophysiology by modulating nociceptive signaling within the trigeminovascular system.
  • Aimovig™ is a 100% human monoclonal antibody designed to help prevent migraine by targeting and blocking the CGRP receptor
  • Aimovig™ binds to the CGRP receptor and antagonizes CGRP receptor function
  • “Although the exact role of CGRP in migraine has yet to be determined, compelling evidence supports its involvement. First, CGRP levels have been shown to increase significantly with migraine and decrease with headache relief post sumatriptan treatment. Second, intravenal infusion of CGRP induces migraine-like headache in migraine patients, demonstrating that CGRP may play a causal role in migraine.
  • Prior to the study, participants who have not received any benefits from other migraine treatments (categories listed above) were excluded from the study.
  • In Studies 1, 2, and 3, 1.3% of patients treated with Aimovig™ discontinued double-blind treatment because of adverse events. Although only injection site irritations are reported by the FDA, the study indicates additional adverse effects, such as cold, upper respiratory tract infection, ankle fracture, viral gastroenteritis, sepsis, colitis, vestibular neuronitis, backpain, migraine, ovarian cyst, and sinusitis. One person also experienced cerebral venous thrombosis (see table 3). The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus—as per the label. Interesting to note that constipation and site irritation are listed as side effects on the label.
  • As with all therapeutic proteins, there is potential for immunogenicity. (Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human and other animal. In other words, immunogenicity is the ability to induce a humoral and/or cell-mediated immune responses; source Wikipedia) “A total of 35 of the 628 patients (5.6%) for whom postbaseline antibody data were available tested positive for anti-erenumab binding antibodies (8.0% of patients in the 70-mg group and 3.2% of patients in the 140-mg group), one of whom, in the 70-mg erenumab group, tested positive for neutralizing antibodies (0.2%)” (see here under SAFETY)
  • In controlled studies with AIMOVIG, the incidence of anti-erenumab-aooe (the main ingredient in Aimovig) antibody development was 6.2% (48/778) in patients receiving AIMOVIG 70 mg once monthly (2 of whom had in vitro neutralizing activity) and 2.6% (13/504) in patients receiving AIMOVIG 140 mg once monthly (none of whom had in vitro neutralizing activity). The neutralizing anti-erenumab-aooe antibody positive rate may be underestimated because of limitations of the assay (emphasis added by me)
  • Antibody development on the efficacy or safety of AIMOVIG in these patients, the available data are too limited to make definitive conclusions.
  • Erenumab-aooe is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
  • Erenumab-aooe exhibits non-linear kinetics as a result of binding to the CGRP receptor (something scary).
  • The effective half-life of erenumab-aooe is 28 days (ouch! If it harms you, just to get to half the dose you need to wait a month!)
  • The carcinogenic potential of erenumab-aooe has not been assessed.
  • Genetic toxicology studies of erenumab-aooe have not been conducted.
  • Mating studies have not been conducted on erenumab-aooe (may not be safe while pregnant).

Aimovig™— The Efficacy

This is a fascinating part because, while it is believed by most that a clinical trial is always meaningful and honestly reported on, here we have an example of a misleading clinical trial summary. There were three clinical trials, all of them examined the number of migraine-free days gained using Aimovig™ compared with taking a placebo. The label, which lists all clinical trial details, chooses to ignore a few important factors. For example, they report reduction in migraine days for only those subjects for whom Aimovig™ provided reduction, yet in the three studies, not one exceeded 50%–meaning it did nothing for at least 50% of the participants. In the tables below where the reduction of migraine days is listed, it is only for those for whom the drug actually provided some benefits. It is important to note that in all of the three trials, migraineurs were able to use additional pain reduction agents on migraine pain days, clouding the information gained from Aimovig™’s usefulness or lack thereof. Here is a summary write-up for episodic migraine sufferers participating in the trial:

Between the start of the study and four to six months of treatment, in the 70-mg group, 43.3 percent of patients experienced at least a 50 percent reduction in the number of migraine days experienced each month.

Between the start of the study and four to six months of treatment, in the 140-mg group, 50 percent of patients experienced at least a 50 percent reduction in the number of migraine days experienced each month.

Between the start of the study and four to six months of treatment, in those receiving placebo, 26.6 percent experienced at least a 50 percent reduction in the number of migraine days experienced each month.

The number of days in which patients had to use specific medications to treat acute migraines was decreased by 1.1 days in the 70-mg group and 1.6 days in the 140-mg group as compared with 0.2 days in the placebo group (here)

Let’s examine the reports on the clinical trials—both episodic and chronic migraines, with or without aura. The first and second groups are episodic migraines, where episodic migraine is defined as <15 migraine days a month. These were randomized, multi-center, placebo-controlled, double-blind studies—the first one was for 6 months. Only 90% of those enrolled completed study 1. There are two treatment groups, one receiving one 70 mg injection once a month and the other receiving one 140 mg dose of injection once a month, and a third is placebo group.

They evaluated the success (called “end points”) after 4 months of Aimovig™ use for the three-month period from 4 – 6 months. The findings are as follows:

Migraine-free days gained Aimovig™ 70 mg Aimovig™ 140 mg Placebo
Change from baseline -3.2 -3.7 -1.8
Difference from placebo -1.4 -1.9
Responders 43.3% 50.0%
Nonresponders 56.7% 50.0%

Let me explain the bolded areas. The 56.7% at the 70 mg dose and 50% at the 140 mg dose represent the non-responding population that took Aimovig™ and had no benefits from the drug at all. Thus, the number of migraine-free days gained (number of migraine-days reduced) represents only those for whom Aimovig™ actually worked. And what was that difference? Less than two migraine-free days compared with the placebo. Given the definition of episodic migraine as <15 pain days a month, saving 1.4 days of pain day for 43.3% of the population means the migraineur still ends up with 12.6 migraine days for a person with normally 14 migraine pain days a month, and for those receiving the 140 mg dose, the reduction is 1.9 days so from 14 days they reduce to 12.1 migraine pain days. This is a rather modest decrease in migraine pain days of 4% for those in the 70 mg group and 6% for those in the 140 mg.

These percentages are derived as follows (for the 70 mg case): up to 1.4 pain-free days difference from placebo, representing (1.4/15) = 9.3%. With only 43.3% of the population gaining this benefit the actual benefit is 43.3% of the 9.3% or (0.093 x 0.433) = 0.04, that is 4% benefit for the whole population.

In study 2, a randomized, multi-center, 3-month, placebo controlled, double-blinded study with episodic migraine—very similar to the previous trial with only a dose of 70 mg once a month, patients were also allowed to use other medicines, like triptans when they had migraines. Here 95% of the participants completed the study.

Migraine-free days gained Aimovig™ 70 mg Placebo
Change from baseline -2.9 -1.8
Difference from placebo -1.0 (rounding on label and not by me)
Responders 39.7%
Nonresponders 60.3%

Note here the responders were even fewer, meaning only 39.7% of the subject received any benefit from Aimovig™, and only gained 1 pain-free day compared with placebo. Given that the definition of episodic migraine is <15 pain days a month, saving 1 day for 39.7% of the population amounts to a 2.65% benefit. A very modest decrease in pain days since the number of pain-days remain at 13 for a person with an average of 14 pain-days a month.

The third clinical trial was with chronic migraineurs, which is defined as >15 pain days a month.

Migraine-free days gained Aimovig™ 70 mg Aimovig™ 140 mg Placebo
Change from baseline -6.6 -6.6 -4.2
Difference from placebo -2.5 -2.5
Responders 39.9% 41.2%
Nonresponders 60.1% 58.8%

In the chronic migraine group we find the least number of responders. While the migraine-day reduction is 2.5 compared with the placebo, we must remember that in chronic migraine, the pain days are greater than 15.  Assuming 16 pain days to be more than fair, saving 2.5 days a month for 39.9% of the population in the 70 mg group amounts to 12.5 migraine-pain days still left and thus the total benefit is 6%, and for those on 140 mg the benefit amounts to 6.4%. Of course, these benefits drop as pain days increase. For a migraineur with 20 pain days, these benefits drop to 5% because she still only gains 2.5 migraine-free days, while the actual migraine-days remain high at 17.5 days. This sort of benefit is of no benefit at all.

Aimovig™ Or Salt?

Given how incredibly little benefits Aimovig™ provides to less than 50% of migraineurs, and with so many unknowns about the possible adverse effects with long-term use, I must wonder: would I ever consider taking a drug like this?

As a migraine sufferer myself, I can reach complete migraine-free status by adjusting what I eat and by increasing my salt consumption. I would never ever consider a drug like this.

Do I need my doctor’s permission to increase my salt intake, as suggested by the Daily Mail? I don’t think my doctor would be very happy if I contacted him every time I used my salt shaker for more salt. Besides, I have increased my salt consumption to be several times greater than the USDA recommendation and while I certainly have no migraines, my blood pressure has never increased either. Salt doesn’t increase blood pressure and for most people there are no risks associated with consuming salt.

Taking any medication always carries the risk of side effects and interactions. Given the miniscule benefits of Aimovig™ as outlined above and the availability of a proven, non-medicinal treatment for migraines, is the enthusiasm for this drug warranted by the facts? What do you think?

Sources

  1. Mente, A. et al. Associations of urinary sodium excretion with cardiovascular events in individuals with and without hypertension: a pooled analysis of data from four studies. The Lancet 388, 465-475, doi:10.1016/S0140-6736(16)30467-6 (2016).
  2. Pogoda, J. M. et al. Severe Headache or Migraine History Is Inversely Correlated With Dietary Sodium Intake: NHANES 1999–2004. Headache: The Journal of Head and Face Pain, n/a-n/a, doi:10.1111/head.12792 (2016).
  3. Tortorella, C. M., Carlo; Fornesis, Myriam; Nussdorfer, Gastone G.;. Calcitonin gene-related peptide (CGRP), acting via CGRP type 1 receptors, inhibits potassium-stimulated aldosterone secretion and enhances basal catecholamine secretion from rat adrenal gland. International Journal of Molecular Medicine 8, 4, doi: https://doi.org/10.3892/ijmm.8.3.261 (2001).
  4. Chu, L. F., Angst, M. S. & Clark, D. Opioid-induced Hyperalgesia in Humans: Molecular Mechanisms and Clinical Considerations. The Clinical Journal of Pain 24, 479-496, doi:10.1097/AJP.0b013e31816b2f43 (2008).
  5. Bigal, M. E. et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. The Lancet Neurology 14, 1091-1100, doi:10.1016/S1474-4422(15)00245-8 (2015).
  6. Dodick, D. et al. Randomized, Double-blind, Placebo-controlled Trial of ALD403, an anti-CGRP peptide antibody in the prevention of chronic migraine. (S52.003). Neurology 88 (2017).

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This article was published originally on August 8, 2018.

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Angela A Stanton, PhD

Angela A Stanton, PhD, is a Neuroeconomist who evaluates changes in behavior, chronic pain, decision-making, as a result of hormonal variations in the brain. She lives in Southern California. Her current research is focused on migraine cause, prevention and treatment without the use of medicines.

As a migraineur, her discovery was helped by experimenting on herself.

She found the cause of migraine to be at the ionic level, associated with disruption of the electrolyte homeostasis, resulting from genetic mutations of insulin and glucose transporters, and voltage gated sodium and calcium channel mutations. Such mutations cause major shifts in a migraine brain, unlike that of a non-migraine brain. A non-migraineur can handle electrolyte changes on autopilot. A migraineur must always be on manual guard for such changes to maintain electrolyte homeostasis.

The book Fighting The Migraine Epidemic: How To Treat and Prevent Migraines Without Medicines - An Insider's View explains why we have migraines, how to prevent them and how to stay migraine (and medicine) free for life.

Because of the success of the first edition and new research and findings, she is now finishing the 2nd edition. The 2nd edition is the “holy grail” of migraines, incorporating all there is to know at the moment and also some hypotheses. It includes an academic research section with suggestions for further research. The book is full of citations to authenticate the statements she makes to be followed up by those interested and to spark further research interest.

While working on the 2nd edition of the book she also published academic articles:

"Migraine Cause and Treatment" Mental Health in family Medicine, November 23, 2015, open access
"Functional Prodrome in Migraines" Journal of Neurological Disorders, January 22, 2016, open access
"Are Statistics Misleading Sodium Reduction Benefits?", Journal of Medical Diagnostic Method, February 3, 2016, open access
“A Comment on Severe Headache or Migraine History Is Inversely Correlated With Dietary Sodium Intake: NHANES 1999-2004” Angela A Stanton PhD, 19 July 2016 DOI: 10.1111/head.12861 not open access, membership required to read it.

Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in NeuroEconomics at Claremont Graduate University, and fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers.

For relaxation Dr. Stanton paints and photographs. Follow her on Twitter at: @MigraineBook

59 Comments

  1. Well I don’t know about all of the people who didn’t see a positive benefit but I went from having a migraine nearly daily average of 26 days a month to 2 days a month. Since I have hgh blood pressure now due to the IGNORANCE surrounding treatment of chronic pain the unsupported unscientific dubious plan by the CDC & PROP to force patients who have been stable and living life to have to have less than 90 MME of opioid medication because drug addicts are overdosing on illegal fentanyl and heroin has left me bedridden, in constant pain with spikes of high blood pressure so I’m spilling protein into my urine but unable to treat it because when I am not having the terrific pain then my blood pressure drops to normal and then high blood pressure medication caused unsafe low blood pressure! So Amigov has been a lifesaver and much better than the other medication that indeed does have horrible side effects with very little benefits!

    • Thanks Rose for your response. I see you posted twice–slightly different in the two, so I leave both on for people to see. In terms of getting a PhD: mine is in neuroscience and economics combined, so I know what I am talking about. However, I am not in the field of medicine research–and I hope never to be. One need not be working for big pharma to know when a drug is harmful–one just needs to look at the side effects reported to the FDA by patients and doctors (available at the FDA website), which are different from what you see on the label of the drug.

      In terms of salt and high blood pressure: salt doesn’t cause high blood pressure. Sugar and carbs do in nutrition, and medications do, in general. Your ending up with high blood pressure–even by your admission–is from having taken drugs for years. So why would you now think that eating salt will increase your blood pressure? While drugs are not essential, salt is!

      Every single cell in your body is alive as a result of salt. There is not a function your body can do without salt. Your body inside is a mini ocean for your cells and bacteria that live there and keep you alive–in fact, make the majority of your body. So why on earth woudl you think that something that is so vital to you in harmful?

      Wait: I know why!! Big pharma said so, so your doctor says so!! Not that it makes any sense.

      For reference, the salt on sunflower is not the problem. The problem is the sunflower seeds, which is high in carbs and roasted in oils. These are unhealthy–particularly the vegetable oil. Also, if you don’t drink enough water, salt actually dehydrates you. And finally, given that migraine is completely preventable, I see no reason to take medicines at all. I have a large Facebook migraine group where we teach migraineurs how to become migraine free by nutritional changes. Once migraine free, there is no need for drugs. You are welcome to join us in our Facebook migraine group to learn how to become migraine free. The group is free and everyone becomes migraine and medicine free. You can find the group here.

      I post my comment under both of your comments.

      Best wishes,
      Angela

  2. I had my first & only shot of Aimovig on March 2 this year. Within 2 weeks of the shot, my hair began pouring out of my head in clumps. I shed devastating amounts of hair for 4 months and had a scalp biopsy that confirmed I was suffering from telogen effluvium. This condition, also known as TE, is a rapid shedding mode when as much as 70% of your hair can be prematurely shed. This has left me with exposed scalp and has been a terrifying and traumatic experience–especially amidst COVID-19. There are many Reddit sites, Twitter posts and pages on migraine websites where people describe similar experiences with their hair. And yet – this is not disclosed as a side effect for any CGRP blocking meds. I took the time to report my experiences to the manufacturer and the FDA in hopes that one day people can know the full extent of risks of these meds. The worst of it is – all this damage & Aimovig didn’t help my constant, daily vestibular migraines or crippling photophobia at all.

    • Dear Erin,

      I am so sorry to hear what happened to you (and to millions of others suffering the same). Thank you for reporting it! <3 A HUGE thank you for that! If everyone who experience side effects would realize that they must report it, warnings woudl happen way faster and drugs woudl be pulled from the market. Unfortunately people don’t know that they should and they don’t know how and the FDA doesn’t make reporting it easy! I hope your hair started to grow back.

      Please join my Facebook migraine group to learn how to prevent migraines and also gain your full health back.

      Best wishes,
      Angela

  3. Aimovig is the best med I have ever taken. 45 years of 18 migraines per month and 99 percent reduction after taking 140mg of Aimovig. Side effects? Who cares. I’d give anything to keep taking this med if it was ever taken away. It has helped me that much. Those who don’t get migraines shouldn’t be able to post reviews. They have no idea what others go through.

    • Pete,

      You are right. People who don’t get migraines should never be writing about migraines.

      Luckily, I have been a life-long migraine sufferer, so I have all the right to write about migraines. I have have been a migraineur for longer than you have been; I started with cyclical vomiting migraines at about age 10. So yes, you are right, people who are not migraineurs have no idea what a migraine is about and have no idea what these drugs do, particularly if migraines are actually completely 100% preventable.

      And since now you know you are talking to a migraineur who has been a migraineur even longer than you have been, and who has figured out how to prevent them, and who has been teaching these skills to many thousands of migraneurs who are now also migraine and medicine free, just like I am, you can trust me: I know what I am talking about.

      Side effects matter. Maybe not so much for seniors since some may not live long enough to care about having their lives cut shorter or living their last few years in misery, but I care and I certainly think that the younger generation cares. I see people whose adverse reactions destroyed their health, their bodies, their lives, their marriages, chance of having children, etc. The list is long. And why face all these bad outcomes when the solution is simple?

      I know that many migraine sufferers cling to their medications–for whatever reason. But many want to have super good lives without pain. My articles here help those people who prefer to be pain free and medicine free at the same time. Obviously it is a lot simpler to pop a pill or inject a drug and continue living the unhealthy life filled with processed carbs and bad rancid oils. Much easier. You chose that life: by all means. Those who read my articles and decided to quit medicines chose super good and healthy lives. This includes me.

      Angela

  4. Hi,
    I am a neurologist working with numerous migraine patients in Australia. I would like to correct some inaccuracies with your article.

    On line 2 of the Aimovig paragraph, you reports that Aimovig is a CGRP-R agonist. It is in fact an antagonist.

    Later in the paragraph you discuss the actions of calcitonin. CGRP is a related, but very different peptide which does not act in the body in the same manner as calcitonin. To conflate the two is like saying that methanol and ethanol are the same.

    In “The label” paragraph you remark that non-linear pharmacokinetics is “something scary”. Many medications and substances (including ethanol) follow non-linear pharmacokinetics, and it is common for monoclonal antibodies due to the way in which the body breaks them down. This is not, in and of itself, scary.

    In “The Efficacy” paragraph you misrepresent the data. The papers do not only report on the patients in whom the drug had an effect, the results are from the patients OVERALL, including the ones who didn’t respond. You confuse the “50% responder rate” (patients who experienced a drop in their migraine days by at least 50%) with the “overall responder rate” (patients who experienced any drop in their migraine days).

    You state that use of acute pain medications would “cloud the information gained”. These are patients who need other medications to help with their pain, and it is unethical to prevent them from taking other therapies which help them. With clinical trials, the aim is that the only change during the trial is with the trial medication, and therefore ceasing use of other medications is more likely to confuse and “cloud” the results.

    Your table reports the results from Goadsby et al
    (A Controlled Trial of Erenumab for Episodic Migraine, NEJM, 2017)
    The 56.7% at the 70 mg dose and 50% at the 140 mg dose DO NOT represent the non-responding population. These numbers reflect the proportion who did not decrease their migraine days by 50%, not the proportion who did not respond overall

    You then make some calculations based on 43.3% saving 1.4 days per month, ending up with 12.6 migraine days per month.
    This is incorrect.
    The use of difference between placebo and drug days is useful in drug trials to establish drug efficacy, but in real life people will still benefit from the placebo effect. The placebo effect is high in pain studies, particularly for injectable medicines, and we should embrace it, because it adds to the medication effect.
    You should therefore use the -3.2 (or -3.7) day number.
    You also arbitrarily use 14 days as a baseline. In the study on episodic migraine, the baseline migraine days was 8.3.
    Therefore ON AVERAGE, the patients taking erenumab 70mg monthly dropped their migraine days/month by 38.6% (3.2/8.3 *100)

    In the chronic migraine study (Tepper et al. Lancet Neurology 2017). The mean migraine days went from 17.9 days per month down to 11.3 days per month (36.9% reduction ON AVERAGE) for the erenumab 70mg group.

    Further studies and a meta-analysis have now been performed (Lattanzi et al. Drugs 2019). The efficacy and safety findings seem to be reproducible in other cohorts.

    Regarding side effects:
    These are new medications, and we must be wary long term or rare side effects which are not identified in the trials. We have certainly had some experience of these – some hair loss and menstrual irregularity have occurred in some of our patients, in addition to the constipation identified in the studies. These should be reported to ensure these are collected systematically.
    There was concern that these drugs would have an effect on cardiovascular function, but so far, this has not been an issue, and this has been looked at specifically (Kudrow et al. Vascular safety of erenumab. Neurology 2020).
    However, most of my patients do not experience any side effects, and it appears (at this stage) to have a favourable side effect profile to many other migraine medications.Your claim that “Many people end up with heart problems because CGRP receptors have a vasodilating function” and “most migraineurs end up with astronomically high blood pressure so now Aimovig is prescribed with beta blockers to most people.” This is not reflected in studies I referenced. Hypertension (high blood pressure) occurred in 0.9% of the placebo group, 0.8% of the erenumab 70mg group and 0.2% of the erenumab 140mg group. Therefore your claims are not supported by the peer-reviewed literature.
    I have not had any patients exhibiting hypertension or cardiovascular side effects.

    In reporting that erenumab just blocks pain signals, rather than stopping the underlying cause of migraine, I think this is too simplistic. The underlying cause of migraine is complex, and there is plenty of ongoing research in this area (CGRP inhibitors were the result of some of this research over the last 25 years). Whilst CGRP inhibitors do block pain signals, they will also dampen down sensory signals and feedback loops which trigger migraine. This is why we see not only a reduction in migraine severity (which would happen if CGRP inhibitors were only working as painkillers), we also see a reduction in migraine frequency.

    Your comment on 31st July 2019 is incorrect regarding half life of medications. The doses will be additive, but the breakdown of the medication in the body will not be linear. When there is more medication in the body, it will be broken down more rapidly, in a manner similar to exponential decline.
    The pharmacokinetics of erenumab are reported as:
    “Less than 2-fold accumulation was observed in trough serum concentrations (Cmin [SD] 5.7 [3.1] and 6.2 [2.9] microgram/mL for episodic and chronic migraine subjects, respectively following 70 mg doses; Cmin [SD] 12.8 [6.53] and 14.9 [6.45] microgram/mL for episodic and chronic migraine subjects, respectively) following 140 mg doses).
    Serum trough concentrations approached steady state by 12 weeks of dosing”

    The bottom line is that we need to be cautious with new medications, and we should try all the cheaper, safer, measures first, before we move on to more untested things.

    But for some people, and with appropriate information about possible benefits and harms, CGRP inhibitors are the correct choice, and we have had some excellent results with them.
    You are entitled to your opinion, but please do not misrepresent the reports of others

    I am not employed by, nor have any conflict of interest with Novartis or any other drug company

    • Dear Rory,

      Over the 2 years that this article has been on this website, I have received many comments–some not posted because they were hostile. I didn’t expect love from doctors and pharmaceuticals when I wrote this article, based on the information that was available at that time. There may have been some errors–as you point out some typos–here and there, though most of what I wrote were literal copies of documents I listed. Since then, the list of adverse side effects are astounding.

      I have screen captures of over five-hundred of complaints, there are also complaints as comments here at the end of this article and also on my private page, see here. Here are some of the adverse reactions in comments that I saved screen captures of:

      “…I only took the one X and achy joints and dizziness to where I could’t rally walk in my house”
      “…I wouldn’t do another CGRP medicine. No! I’ve been off a few (3+) months and achy joints which was sooo bad… big time dizziness all the time…”
      “…Does anyone know how long X stays in your system after you discontinue treatment? My last injection was in Septembr… My joints, knees, feet, fingers still ache every day”
      “…Anybody have altered behavior? like uncontrollable crying, anger, depression, meltdowns?? (Anxiety & Depression)”
      “…Does anyone feel as though your skull bones hurt to the touch? It’s like some areas of my skull are untouchable”
      “…strange dreams and talking in my sleep”
      “…X gave me extreme anxiety. First month I started getting anxious at night, second was all day, by the third uncontrollable anxiety attacks and panic attacks multiple times a day”
      “…X wears off after the first 10 or 12 days. I am thinking of takign 2 doses. I also take imitrex almost daily”
      “…I did not do well until I combined X with Botox. However, after a couple of months I started getting more frequent migraines”
      “…About 2 weeks in I noticed more hair than normal shedding.”
      “…I am so scared. I am losing my hair like I was on chemo or something”
      “…Has anyone been dx with liver failure since starting X? I don’t drink at all and in Oct my liver was fine. Started in Nov”
      “…my liver enzymes were 4 times what they should be. I’ve been having tons of swelling as well”
      “…my kidneys are declining now”
      “…my doc wrote me prescription for prednisone and a heart drug to take this shot! really?! there was nothing wrong with me before I took it. He said I will need these every month”
      “…Anyone else on X packing on the pounds? 25 lbs in 3 months”
      “…Has anyone else’s migraine gotten worse with these new CGRP injections? Mine have with all 3!”
      “…My son is almost nonstop chronic migraine. He took 3 shots Jan 30th. He has had 4 migraine free days since then and no migraine free days since Febr 17th. The last 5 days have been 7/8 pain level”
      “…with X I had daily migraines which increased in number and intensity…it made my abortive medications completely stoop working”
      “…far more bed bound days with migraine and depression.”
      “…I’ve tried X and it landed me in the hospital twice, 4 ER visits, one 24-hour observation and a 7-day admittance. It’s been brutal”
      “…I started experiencing hair loss about five months in”
      “…My blood pressure has been way higher (150s/90s) rather than my normal (120s/70s).”
      “…I had to get on bp meds after a few months of taking X”
      “….I am having flutter days and night”
      “…BP is higher and mine is normally low. Chest and mid-back pain with weird heart flutters and flopping”
      “…CGRP plays a huge role in our cardiovascular system… that explains my chest pain, irregular heart rhythm and increased blood pressure. CGRP is a potent vasodilator that possesses protective mechanisms that are vitally important in cardiovascular health”
      “…I quit after 2 shots. Didn’t like the after effects, plus it increased my migraines…”
      “…So I tried X for just a month and had annoying side effects like massive hair loss, joint pain and my rescue migraine meds weren’t working as well! Worse part no difference in my chronic migraines”
      “…I am in my rd month on X. I have had a terrible migraine every day this month. ”
      “…muscle cramping”
      “…I am at the end of my 1st shot, 2nd due in about a week. The muscle pain is awful”
      “…also acne I’ve never ever had issues but I’m breaking out bad this go round”
      “…it didn’t help my migraines unfortunately”
      “…Upper respiratory issues have been reported…”
      “…For me low grade fever, night sweats, day chills, hot flashes, cold clammy skin, flush face, coughing, pain in right lymph node, gained 15 lbs, upper respiratory infection, blurred vision. hair loss, tongue/fingers/toes numb & tingling, swollen ankles.”
      “…Yes. I have far more colds, including fevers, aches, sore throats and sinus issues during the 3 months I took the shot and 2 months since discontinuing, It also increased my migraines…”
      “…I’ve had bronchitis two of the 3 months I have taken it so far”

      These are taster comments of at many screen shots I so far collected, just to give you a taste how “great” CGRPs are. X stands for more than one type of CGRP inhibitors, be it any of the kinds available at the time I took these screen shots–there was more than one on the market.

      What I wrote in the original article is not a misrepresentation, but an early attempt at explaining how the drug works–again, based on the then available literature. Whatever errors you find, were errors in the documents I used. As you can see, there is not much to brag about when it comes to CGRP inhibitors, so my article–as is–remains. And, in my next article about CGRP inhibitors, I will be significantly harsher against this drug class. By now the number of migraineurs with serious adverse effects is dangerously high.

      These drugs should not be on the market at all. Migraine sufferers are not guinea pigs to be experimented on and using a drug class that affects CGRP receptors across the whole body, causing severe health complications.

      Best,
      Angela

      • Angela my wife committed suicide and I firmly believe that it was due to this Aimovig. I noticed her depression got worse when she started the shots and no motivation to do anything for at least 8-10 days after the shot. By the third month shot she she would start to mention on not living anymore . When reached out to the doctor and due to this COVID situation I wasn’t able to attend the video phone call but she mentioned to her neurologist about her feelings and the doctor had mentioned from what she told me that it was normal and by the sixth shot it will all start to blend in and her migraines will subside. A couple of days after her fourth shot she took her own life. So again I know deep in my heart that my wife would NOT have done this if it wasn’t because of this Aimovig! With that being said not only am I finding out that my feeling is right but also finding out people are getting depressed drastically with this medication! Why isn’t there any warning for this medication? Especially if you’re suffering from depression already? I lost my wife, best friend, my world and my kids did as well and I don’t want anyone else to feel what I feel EVERYDAY!!

        • Dear James,

          I am so sorry that your wife took her life as a result of anything, let alone a drug like this. I am very sorry and my deepest condolences to you and family.

          Unfortunately there are many factors here. The first factor is the lack of reporting. Individuals–like your wife or now you–are responsible for filing an adverse report on the FDA website. Unfortunately the FDA makes such reporting very difficult and they keep on moving the link every time I look for it. Currently you can find it here and you can download the PDF and fill in the form. They also have an only adverse events reporting submission, which you can find here.

          The doctors too are supposed to be submitting adverse reports, but since most don’t believe in adverse events–and I am not sure her doctor believed that she took her life as a result of Aimovig–they don’t usually report anything. So it really is on the shoulders of the consumer to report all adverse events. And the FDA will post a warning on the label only after there have been a number of complaints with the same symptoms–and I don’t know what the magic number is.

          It is unfortunate that so many people are misinformed by the drug companies through their doctors about the value of these medicines. And, on top of it, migraine is preventable. Unfortunately the power of big pharma is so strong that many migraineurs rather take a drug than change their diet. Sad but true.

          Big hugs to you,
          Angela

    • Rory
      I wrote this to Angela and I will to you as well…
      Rory,
      my wife committed suicide and I firmly believe that it was due to this Aimovig. I noticed her depression got worse when she started the shots and no motivation to do anything for at least 8-10 days after the shot. By the third month shot she she would start to mention on not living anymore . When reached out to the doctor and due to this COVID situation I wasn’t able to attend the video phone call but she mentioned to her neurologist about her feelings and the doctor had mentioned from what she told me that it was normal and by the sixth shot it will all start to blend in and her migraines will subside. A couple of days after her fourth shot she took her own life. So again I know deep in my heart that my wife would NOT have done this if it wasn’t because of this Aimovig! With that being said not only am I finding out that my feeling is right but also finding out people are getting depressed drastically with this medication! Why isn’t there any warning for this medication? Especially if you’re suffering from depression already? I lost my wife, best friend, my world and my kids did as well and I don’t want anyone else to feel what I feel EVERYDAY!!

    • Thank you for your feedback! I have had tremendous success with Aimovig and since I have pre existing episodes of high blood pressure I would be afraid to increase the use of salt, having an addiction to salted sunflower seeds I know first hand that too much salt causes inflammation and water retention! So I don’t buy them often! I can’t take medication to lower my blood pressure because it is episodic but extremely high to dangerously high when I get uncontrolled pain which is a different problem for those suffering chronic pain! However I haven’t noticed any increase in blood pressure, or any side effects except for the very real lack of migraines with nausea and aura from nearly every single day down to nearly zero days! So reading you’re response was helpful to alleviate the fears that this article induced. I don’t miss that she may have a PhD but not in biochemistry or neuroscience or really any meaningful scientific fields that would normally research this type of medicine! So thanks for your input!

      • Thanks Rose for your response. I see you posted twice–slightly different in the two, so I leave both on for people to see. In terms of getting a PhD: mine is in neuroscience and economics combined, so I know what I am talking about. However, I am not in the field of medicine research–and I hope never to be. One need not be working for big pharma to know when a drug is harmful–one just needs to look at the side effects reported to the FDA by patients and doctors (available at the FDA website), which are different from what you see on the label of the drug.

        In terms of salt and high blood pressure: salt doesn’t cause high blood pressure. Sugar and carbs do in nutrition, and medications do, in general. Your ending up with high blood pressure–even by your admission–is from having taken drugs for years. So why would you now think that eating salt will increase your blood pressure? While drugs are not essential, salt is!

        Every single cell in your body is alive as a result of salt. There is not a function your body can do without salt. Your body inside is a mini ocean for your cells and bacteria that live there and keep you alive–in fact, make the majority of your body. So why on earth woudl you think that something that is so vital to you in harmful?

        Wait: I know why!! Big pharma said so, so your doctor says so!! Not that it makes any sense.

        For reference, the salt on sunflower is not the problem. The problem is the sunflower seeds, which is high in carbs and roasted in oils. These are unhealthy–particularly the vegetable oil. Also, if you don’t drink enough water, salt actually dehydrates you. And finally, given that migraine is completely preventable, I see no reason to take medicines at all. I have a large Facebook migraine group where we teach migraineurs how to become migraine free by nutritional changes. Once migraine free, there is no need for drugs. You are welcome to join us in our Facebook migraine group to learn how to become migraine free. The group is free and everyone becomes migraine and medicine free. You can find the group here.

        I post my comment under both of your comments.

        Best wishes,
        Angela

  5. This is a very interesting article. I have 4 generations of migraine sufferers in my family and believe I was symptomatic at birth, e.g. the extreme colicky baby. I am now 72 and lately was on Ajovy for 10 months. Then when insurance would not cover it, switched to Aimovig and have been on it for 1 month. These two drugs are the only things that have EVER worked for me. To say migraine has ruled my life is an understatement. It has defined me, limited me, ruled my life ruthlessly. My whole life I have never gone longer than 3 weeks and usually 1 1/2 weeks without a migraine and that was on daily & rescue meds.
    This group of drugs for me is how I believe people felt when Penicllin first went on the market, a miracle!

    Since my first pregnancy in 1977 I have been on a low salt diet and was proud of it. I am also being treated for osteoporosis due to leaky kidney syndrome, too much CA in the urine. Just in the last 6 months my serum CA level has become elevated which precipitated my endocrinologist to switch me from Prolia to Evenity. At the same time I fractured my elbow. My endocrinologist & neurologist both know what I am taking but I don’t think they have drawn a connection. All of these drugs are so new and I sometimes feel like I’m the guinea pig. I truly don’t want to give up the Aimovig but am I “robbing Peter to pay Paul”? Tomorrow I see my neurologist and am definitely bringing your article. Thank you.

    • Dear Jo Ellen,

      It is very unfortunate that with the low salt diet–to which you were proud of–caused the weakening of your bones. Elevated calcium levels signal that calcium is leaching from your bones into your blood circulation for your cells’ use. Calcium is needed for the use of cells, all cells, in addition to forming your bones. In order for calcium to stay in your bones, you need to eat proper sodium, in addition to proper protein and phosphorus in your diet, else the calcium will be pulled. In addition, you also need high levels of D3 and the proper levels of certain B vitamins. Unfortunately, few doctors understand the importance of vitamins and minerals as they work together, cofactors for each for specific functions that are often overlooked.

      One of the biggest errors, for example, is the recommendation to take calcium supplement for osteoporosis or any sign of weakening of the bones. I don’t want to get into detail on this here since that’s not the subject of your comment.

      However, you are very correct about having been a guinea pig for these drugs. The number of migraineurs who cannot tolerate these drugs is growing exponentially. CGRP inhibitors can cause major havoc with the body because there are CGRP receptors EVERYWHERE in the body. I have already heard of a few people whose pancreas is on the verge of complete dysfunction as they are unable to shut production of insulin off without functioning CGRP receptors (this can cause them to become T1D in no time if the receptor damage is not reversible and we have yet to see it reverse!). Many people end up with heart problems because CGRP receptors have a vasodilating function, which the inhibition blocks. So people end up with severe hypertension. Many doctors now prescribe CGP with beta blockers and also corticosteroids, as many people get full body inflammation in response to any of the CGRP inhibitors.

      So the amount of damage you may have ended up with is really unknown. It is best to quit CGRP inhibitors and move to a migraine-preventive process. I have a book about it and two groups on Facebook, with the main protocol group here. You are welcome to join and find out how to prevent your migraines.

      Best wishes,
      Angela

  6. I’ve been on aimovig for just over a year now. I’ve gone from 30 severe attacks per month – yes that’s right, every single day for the past 15 years…. to zero. I have my life back. I have experienced no side effects at all. It has legitimately saved me from suicide.

    It is entirely up to the person suffering to make a call on whether it’s worth it but I would seriously advise reading multiple sources and studies and not buying into fearmongering. Think critically.

    • Dear Bia,

      I am very happy for you that you have zero migraines–and obviously no adverse effects. Unfortunately I have so far been in contact with over 100 migraineurs who took (note past tense) Aimovig or a few took other brands and all had major adverse reactions. Some immediately but others only after 6 months or longer. Some of the side effects are horrible and up to March of 2018, 3 deaths have also occurred.

      One of the major problems with CGRP inhibitors is that CGRP is required for proper heart function. It controls and maintains proper vasodilation to keep blood pressure low. Unfortunately, most migraineurs end up with astronomically high blood pressure so now Aimovig is prescribed with beta blockers to most people. Aimovig also causes massive whole-body inflammation to many, so they now also start each month’s shot with a taper-dose of Prednisone!

      And these are just some of the adverse reactions! There are some tragic ones as well.

      I recommend to everyone who considers CGRP inhibitors to understand that migraine is not a disease and can completely be prevented–100% preventable. Migraine is a genetic condition that makes migraineurs extremely carbs sensitive (intolerant) and need much more sodium in their electrolyte that other people. Once carbs are reduced or are gone completely and salt is increased, migraines magically disappear.

      Those who wish to try the non-medicinal approach should consider joining my migraine group here. Why take medicine when it is not necessary? I have had migraines all my life–same as you, every day for the last many years of my migraines. Now I have been migraine free (and medicine free) for over 5 years.

      Best wishes,
      Angela

    • Dear Frank,

      That you for asking. I personally would not take it under any condition, given the major side effects, and particularly not if I had pulmonary hypertension.

      If you visit any Facebook groups associated with Aimovig (or any other CGRP), you will find that some of the major side effects of Aimovig are as follows:

      –hypertension so many doctors now prescribe it with a blood pressure reduction medicine
      –full body inflammation so many doctors now prescribe it with prednisone
      –bronchitis and pneumonia

      these three in addition to hundreds of others but these three are show-stoppers for your condition. However, if you have migraines, why not join my groups to learn how to become migraine free but changing your lifestyle. Everyone can become migraine free and medicine free by the proper lifestyle changes, which is my specialty. Please join us in my starter group here.

      I am looking forward to seeing you there,
      Angela

  7. Hello Angela,
    I found this article after researching my side effects on Aimovig. I have hormonal migraines, every month during my period, and if there is an incoming storm (low pressure system). My mother, grandmother, great-grandmother, etc. got them, as well. Mom’s went away for the most part with menopause (I am 39, so I still have a few years yet to go.) I started Aimovig in December in a state of desperation. I could not take the pain, anxiety, stress, depression anymore, especially while working full-time as a teacher, and with a 7-year-old at home. The “no side effects” bit convinced me, I had refused to try any of the other drugs that had a laundry list of side effects, and triptans made me feel horrible without fully working, so I thought this was safe and a Godsend. I have responded exceptionally well to the drug, only having one or two migraine days per month, and those went away quickly and could be beaten back with caffeine. However, I have had several side effects that all seem thyroid related (constipation and bloating, extreme fatigue, not quite depression, but a loss of the joy I used to feel in things, etc.) Who knows what is happening that I cannot see. Quite frankly, I believe I already suffered from some form of hypothyroidism, so this has antagonized it in the extreme. The constipation and bloating has been the absolute worst. My stomach is so distended, I just do not feel like myself, and I am very concerned about a slow bowel because colon cancer runs in the family. Not to mention the nightmare of trying to get insurance to even cover this drug. So, after 7 months of free injections using a coupon, and reading your article, I am now considering going off of this “miracle” drug, but I am terrified of the migraines coming back. I just ordered your book on Amazon for delivery Friday, and I am *very* good at following a regimen, so I suppose I am just reaching out for reassurance that this is the right decision, particularly with the new school year looming. Does this work for menstrual migraine? And if I really do have hypothyroidism, will taking a drug for that help or hinder my journey? Thank you for any feedback!

    • Hi Laura,

      Thanks for your story. Very sorry about the side effects of Aimovig–unfortunately they are all too common and often are very serious. Here is what I suggest:

      1) You should know that since the half-life of Aimovig is 29 days, and since you took it for 7 months, the clearance of Aimovig from your bosy is going to be many months after you stopped–at least 5-6 months. And that is because the first Aimovig half life in 1 months, and that same dose’s second half’s half-life is another month and the half-life f whatever still remained is yet another month and so forth. So when you took your 2nd Aimovig shot, you only had half of the 1st shot out of your body so for a month you had over 1.5 doses. Then in the 3rd month your 1st Aimovig is about 2/3rd out of your system, the 2nd month is half out of your system and now the 3rd month is a whole dose, so you have over 1.75 doses in you and so forth.

      2) This means that you should not have any immediate pain returning that is more than what you used to have while you were taking the drug
      3) You have time to start a lifestyle change that my migraineurs do in my migraine group, so join us there. There are other migraineurs in the group who got hurt by Aimovig and are now on the protocol, learning how to become migraine free.

      Glad you purchased the book. It gives you a basic explanation of what it takes to be migraine free. In the migraine group we help you implement the solution and also provide further help and even recipes.

      I am looking forward to seeing you in the group!

      Angela

      • Thank you very much for all of the info and your quick reply! I have high hopes, because before I even visited a neurologist for the first time 2 years ago I had decided to go without sugar, and for 2 months I had the fewest migraines I had had since my daughter weaned (I had zero migraines during pregnancy and breastfeeding! Do you have any idea why that is?); however, I did not know about the salt and low carbs, so I did not have all of the pieces to the puzzle. Then it all went in the gutter when my very first visit with a neurologist resulted in a prescription for pills. I remember at the time wondering why it is that doctors never ask about your eating habits! I am also justifiably put off that not once was I told about migraineurs losing sodium. Why did it take me using a drug, suffering side effects, then having to do my own research on the side effects I was experiencing in order to come across your article? It seems like much more than a coincidence! …In the meantime, I am interested to see if following the Protocol will help with the one or two mild migraines I am still experiencing while on this drug. I will let you know the results!

        • Hi Laura,

          Most migraineurs have no migraines during pregnancy and nursing. This probably has hormonal origin plus the fact that moms-to-be eat and drink better than normally. In addition, the baby’s system may help the mother. For example, a friend of mine has very serious psoriatic arthritis and was on medicine before she got pregnant. While she was pregnant, her baby’s immune system protected her from the pain. So it is possible that the baby’s electrolyte system is also helping the mother. I am not sure.

          Most doctors have no idea about the sodium loss because this isn’t taught in med school and most researchers also have not yet understood it. It is just now that I start seeing some articles coming out of the woods investigating the sodium connection, except that they still understand it backwards and want to stop the sodium flux. It will be a long time before the industry will try adding simple sodium to the diet. In some countries they are actually doing it already.

          Good luck and looking forward to you joining us.

          Angela

  8. Thank you so much for sharing this article!

    I have Trigeminal Neuralgia (TN, type 1) and middle ear problems due to clogged Eustachian tube.
    When I first read about a CGRP receptor agonist I thougt it might be worth a shot because TN pain uses the same pain-pathway (the trigeminal nerve) than migraine.
    Also interesting: the drug used for TN is a calcium-channel blocker.

    Reading your article I kept on thinking what’s the missing link here in my case…?

    • Hi Alice,

      I don’t think there is a missing link. CGRP receptor inhibitors prevent pain signal but not action potential of the neuron or the release of neurotransmitters. Voltage gated calcium channel blockers don’t block pain signals but prevent the release of the neurotransmitters. Neurotransmitter-release is the purpose of the action potential, and so by the neuron’s inability to release neurotransmitters, the action potentials will also reduce. In addition, since neurons remain in connection in order to communicate, and communication is via the neurotransmitters, when neurotransmitters don;t come, connections break and the brain is in degenerative mode.

      So with the two combined, the initial goal is to prevent the neuron’s activity and whatever activity it retains, prevent the pain signals from reaching the pain receptors.

      There are many health concerns associated with both actions independently and combined they cause very serious issues. In addition to the host of side effects that range from hypertension, full body inflammation, hair falling out, chronic bronchitis, chronic colds, acne, swelling rashes, fever, loss of muscle functions, chronic fatigue syndrome, etc., both of these cause permanent changes in the brain–degenerative.

      I hope this helps you understand these drugs,
      Angela

  9. I have a question. I’ve been on this shot now for 2 weeks & haven’t started my period. I’m concerned because I’m not pregnant & usually regular with my periods. I’ve taken blood pressure meds before this shot. To help with the migraine/headaches. Had all normal cycles. Can this shot cause the no period? & I do want to try having a baby next year will it effect any of that?

    • Hi Jennifer,

      Not sure about getting pregnant but late/delayed/stopped periods have been reported. Here is a huge list of review and over 50% is really negative, and here is a page where women complain about late periods.

      It is a monster drug from what I read in CGRP Facebook groups. The half-life of the drug is 29 days–meaning to completely leave your system it take several months. Since it is new, few side effects are officially reported in the official database, please report your case here.

      In terms of long-term side effects: unknown. Everyone taking a drug like this, which manipulated the brain, is taking a chance. Please feel free to join my migraine group to find non-medicinal migraine treatment and prevention.

      Angela

  10. This is a great article regarding salt intake. I’m a health researcher and my mother-in-law has chronic migraines. I noticed that she, like many other migraineurs, is taking several “salt stealer” medications such as anti-depressants and anti-anxiety meds. Hyponatremia (low blood sodium) is listed in the Prescribing Info for these medications. Low salt, electrolyte imbalance, and the body compensates by adding water to cells, the cells (including brain cells) expand and bad things happen (headache, confusion, etc.). Additionally she normally skips breakfast so no food is counteracting the meds that are taken at night so they have extra time to perform their salt stealing activities. I’m of the opinion humans need more salt and migraineurs Especially need more salt. On a side note, I worked in pharma for a long time, but stopped as the companies talked about profits much more than about patients.

    • Dear Jonathan,

      I completely agree. Most medicines given t migraineurs block or remove sodium from the cells, causing hyponatremia (or what feels like hyponatremia, even if not measurably so by electrolyte test) in migraineurs. In addition, migraineurs have a lot busier brain activity with their hyper sensitive sensory organs, so they need more salt than the general population does.

      Skipping breakfast is a problem on medication for all, since meds assume food, though if she were not taking any medications, skipping breakfast is a great way to prevent migraines. A proper and well-managed fasting is extremely healthy for migraineurs; it resets their metabolic system, brings glucose out of all places, and makes them use it up. Many migraineurs–all migraineurs under my care in my Facebook groups–find that a very much reduced carbohydrate diet (such as the ketogenic or the carnivore diet) with time restricted feeding, ample salt and water, and without any medicines (this is important!) is completely migraine preventive.

      I agree with you that all humans need more salt.

      I was reading an academic article with some unrelated topic from the early 1900’s where they looked at various health markers for a lot of women–I think it was menstrual cycle related. One of the markers hit me in the eyes! Sodium! Today, the healthy lab range is between 135-145 but there was not a single test result in the trial’s sample under 143! Most of the women in the trial had sodium ranges of 143-158! I suppose it would take quite a digging into research to figure out the “who done it” to have reached what we call normal ranges today, since they are clearly not normal.

      I completely share your disappointment with the healthcare system, which is really a disease care and has no incentive to help patients.

      Best wishes to you and to your MIL!
      Angela

  11. I took Aimovig 70 mg in November in December, I felt like I got more headache days overall, but was hoping something would change later. In January and February took 140 mg and my condition worsen, oh my! I have migraine and headache most days in January and so in February literals every day. Plus the constipation on mostly fruits/ veggies whole wheat bread diet. I don’t believe it has no side=de effect, I think it makes things worse.
    For those with bruises on injection sites: massage gently the site for 2 min after injection is all!

    • Dear Elena,

      Thanks for your comment. I am very sorry to hear about the Aimovig adverse effects. Please be sure to spend a minute and report your experience with the FDA here. They have an online form that takes less than a minute. You can print a form out and mail it in, and there is also a toll free number to call if you prefer that way.

      Please feel free to join my FB migraine group–already several ex-Aimovig users are in the group for recovery and to learn how to become migraine free without any medicines. Over 5000 migraineurs have gone through this group over the past few years and we have lots of success.

      Best wishes,
      Angela

  12. Salt is a HUGE contributing factor to my migraines…every time I eat salty foods, I can guarantee having one. I’m meeting with my neurologist this week to discuss Aimovig and Emgality, and depending on what kind of financial assistance I can get, will try one of those. A friend is currently on Aimovig and said it has been “life-changing” for her.

    • Dear Beth,

      Salt is not a migraine contributing factor–unless you are piling salt in without potassium, and you continue to eat carbs. There is a LOT of information that is in my book that explains what you are misusing and why salt increases your migraines.

      There are many people for whom Aimovig and the other CGRP inhibitors cause no adverse reactions but way too many end up with major problems–many may be lifelong irreversible problems. CGRP inhibitors are not preventing migraines. They only remove the sensation of the pain for some, and only some of the time. The rest of the time these people still take their other migraine medications. I have not met anyone yet you was migraine free. And if you have symptoms of migraine such as inability to talk, see, walk, etc., you will have those symptoms only without pain. So be careful about having migraines without pain–particularly if your migraines come with vertigo, dizziness, aura, or have hemiplegic migraines.

      Best of luck.
      Angela

  13. Interesting article on the CGRP drugs. I suffer from chronic migraine and have been offered this treatment several times from the trial stage onwards and while I am usually open to trying most things for my migraine my gut instinct about this drug is to not touch it. I’m not a medical person but my limited understanding of CGRP is that it is an essential neuropeptide in the wound healing process and that blocking its action over long periods of time could do serious damage to the bodies connective tissues and muscle. I would be very worried about its effects on my heart over time. I am already concerned about the long term side effects If this class of drug is seen by drugs companies and doctors as a long term preventive for migraine sufferers.

    I wish more research was being done into the actual causes of migraine rather than how to merely stop the pain as it is clear that migraine is a much more systematic illness and not purely neurological.

    • Hi Anne,

      I am glad that you are thinking seriously and have done some research. I completely agree with you. The human body is an extremely efficient and well-optimized body that needs every single receptor to function. Blocking any (inhibition is blocking) will have negative consequences on the long run. It already has major negative consequences for many migraineurs: hypertension and whole body inflammation (many doctors now prescribe Aimovig with a drug for hypertension and prednisone for the inflammation), hair falling out, depression, anxiety, bronchitis, sinus infection, pain in muscles and joints… a host of major problems that people didn’t have and now they do as a result of Aimovig, plus the drug for some caused massive migraines that woudl not break for 30 days and even those for whom the drug helps to some degree, need to continue their other medicines, else they are back to where they were, with full blown migraines.

      In terms of your plea for finding the cause: the cause is known and is published only ignored. No one makes money by knowing the cause, particularly if the solution doesn’t contain any medicines. I have published the cause (tried in various journals but none wanted to consider an article that cuts medicines out!) in my book. The first edition published 5 years ago, the 2nd edition, the Complete Guide, published in 2017. I have worked with over 5000 migraine sufferers of all ages, both genders, and all types of migraines and the protocol is extremely successful because it is a systemic approach. Like you wrote: migraine is a systemic condition and not neurological. Aimovig and other drugs try to reduce the pain but don;t address the cause of migraines.

      I opened a couple of Facebook migraine groups to guide migraineurs–it is hard to understand things–let alone read a book–while having a migraine. In addition to the original protocol that is discussed in the book, I extended and developed a ketogenic and a carnivore diet program for migraineurs. Migraineurs are so different from other populations that the ketogenic diet had to be modified. Most migraineurs do best on the carnivore diet for reasons that are explained in my book.

      So the solution is out there and doctors are starting to pay attention. There are many doctors also in my group, learning how to do and what. I recommend you look into and consider to join the protocol group, which is our starter group.

      I am looking forward to seeing you in the group. 🙂

      Angela

  14. I have taken just one 70 mg shot. I have gone from daily intense migraines to NONE. With no side effects except an usually nasty bruise at injection site ( and i did many rounds of IVF so am not picky). I worry about the newness of the drug and side effects in future but for 12 days have had a normal life.

    • I am glad it is working for you so far Furmat. I hope it will continue to work for you. I receive emails and comments from people who have major adverse reactions.

      The most complaints I so far received:

      1) hair loss
      2) sinus infection
      3) ear infection
      4) bronchitis
      5) other respiratory infections
      6) major constipation that requires prescription-dose daily relief
      7) insomnia
      8) anxiety
      9) depression
      10) major migraine nonstop for over 30 days

      It is important for you to know that Aimovig blocks the pain sensors that would tell you that you have a migraine and not the migraine itself. So if you usually get cognitive changes during a migraine, you will still get those cognitive changes only not the pain. This may impair your judgment so be aware of that.

      Best,
      Angela

  15. I just found this site. I have had severe side effects from a similar new competitor drug Ajovy. It’s given me severe vertigo, heart palpitations, muscle pain and more. This one actually lists no side effects but injection site reaction. I do think these new drugs could potentially be very dangerous and people don’t even know about the risks involved.
    Interestingly enough, I had recently added more salt to my diet and was feeling much better before decided to try this drug.

    • Hi Lisa,

      Very sorry to hear about the severe side effects you had. I wish migraineurs woudl read this article before they start any of these new drugs for migraine. Very happy that you are increasing your salt. Join my Facebook migraine group to understand why salt is important for migraine prevention and how to apply it successfully, together with other changes that help prevent migraine completely.

      Looking forward to seeing you in the group,
      Angela

  16. Thank you for posting your analysis. I read the clinical review from the FDA and although I’m not good at stats, I got the same impression as you did about the “reduction of headache days”. I also couldn’t help but notice the following: In a total of 2499 people who got at least one dose of the drug in the named trials, there were: two cardiovascular-related deaths, 2 spontaneous abortions (out of 23 pregnancies), 17 cases of malignancies, 10 patients with thrombosis/embolisms, 27 patients with suicidal ideation, 8.9% developed anti-drug antibodies, and more.
    Headache prevents me now.. but here is the link: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000MedR.pdf

    • Precisely Clarity. Their label on the package doesn’t contain any adverse reactions, only constipation, as if that was the most important one. Mind you, I have yet to talk to anyone who didn’t end up with major constipation and so that is not even a “probably” side effect but a “for sure this will happen to you” story. The rest of the adverse reactions–some fatal–for whatever reason are not noted on the FDA label. This is very sad since many migraineurs jump on this medicine, believing it is so great, and end up getting hurt. Several already contacted me. Sad story.

      Thanks for the link to the Clinical Reviews. Great (long) read for people considering to use Aimovig.

      In terms of your migraines, please join my migraine group so we can help you.

      Best wishes,
      Angela

  17. Hi there,
    Great article. I normally will not try new meds but was desperate with my chronic migraines. I did a 70 mg shot a week ago. This drug is awful!!!! My migraines have been daily and so intense my normal abortive meds are working. Also I am dizzy, nauseous, fatigue beyond belief, and insomnia bad. I look and feel like death. I wish I had never tried this! I am scared to death. Is there anyway to counter act this or get it out of the system faster? I can do nothing but lay down.
    I was told by my neurologist the only side effect was constipation. Which I now have as well.

    • Very sorry D about your experience. I am glad you visited this site and learned the truth about Aimovig. I wonder when (if) the FDA will update the label to reflect the true adverse effects. The FDA has an adverse event reporting system that I just looked for so you can report your adverse events easily here. The more reports the FDA gets, the faster the drug will get warnings on it, and in time may even be pulled form the market if there are enough serious adverse events. Please report!

      In the meantime, to help you with your migraines–once Aimovig starts to leave your system (half-life is one month! Half-life means the time it takes half the dose you took to be cleared from your body), you can start applying the Stanton Migraine Protocol(R), which will help you get over your migraines and learn how to prevent them. I am a migraine sufferer who can prevent my migraines and I ma one of over 4000. Try it, it is free. You can find us here.

      We are looking forward to helping you,
      Angela

  18. Interesting article. I found some of your language to be hyperbolic (“given the miniscule benefits”, “misleading clinical trial summary” and from a commenter “false hope, minimal help, sheep mentality that Big Pharma desires”) making me wonder what IS your actual motivation? You must know that you are extremely lucky to be able to control your migraines through diet alone, but attempting to discredit a new medication that is providing alleviation of debilitating pain to a wealth of sufferers is curious.

    Then, lo and behold, we learn you are promoting your book, self described as “the holy grail of migraines”.!! Wow, what a byline. We don’t need medication…we need your book!

    I just received my second round of shots, and during the first month experienced 16 completely headache free days and a had a 50% reduction in migraine days and the days I did get a migraine, the pain level never went over a 3 and most were thwarted completely with aspirin and a cup of coffee. Before Aimovig, it was daily headaches with 10-12 migraines with pain levels from 3-9. I tried maganesium, I tried B vitamins, I tried lemon/salt drinks, I tried elimination diets, I tried DHEA, I tried fish oil, I tried NAC+, I tried Butterbur, I tried Feverfew, I tried the emotional feedback technique, I tried other mind/body techniques, I tired CBD oil, I tried meditation all with limited or negligent results. Then I tried Aimovig and to experience that many migraine/headache free days in the 33 days following the shots is REMARKABLE. Who knows, maybe at this point it’s placebo, but I’m remaining positive. I wish you would too, give hope, don’t squash it.

    • Dear Cheryl,

      There is nothing hyperbolic about my comments–they are true statements that reflect what the actual clinical trial results show versus what the FDA label shows—I think the people with hyperbolic statements and conflicting interest are those who make this drug available and mislead the migraine population. This drug is not a migraine prevention drug–it merely blocks pain sensors. What that means–an example may be a broken arm: you broke your arm but your pain sensors are blocked, so no pain is felt, therefore, you continue to play tennis with a broken arm. Not very smart and is certainly not healthy or preventive.

      I just received yet more emails from migraine sufferers on Aimovig and also a comment on one of my blogs, having adverse effects and should they continue the drug. My friends and I also keep an eye on various Facebook groups where migraineurs use Aimovig–or other brands of the same pain-sensor blocking drugs–and see the many complaints and problems.

      In terms of reducing your migraine pain-days by 50% — this is the exact number advertised by big pharma, and the way you put it (not 49.9 or 50.0001%?), makes me think that you are connected to big pharma in some way–which is fine with me. For chronic migraineurs, like I am (if I don’t prevent them), 50% reduction in pain days means it is a horrible month. Why not 100%? It can be done easily, freely, and can be a permanent solution once you understand how it works.

      In terms of me being “lucky” in that I responded to the Stanton Migraine Protocol(R)… yeah… if you understand what migraine is, you can prevent it and feel lucky too. I am not the only lucky one; over 4000 such lucky people so far since I started to help other people! All of those who started the protocol and stuck with it are migraine free and also medicine free–and, by the way, the ketogenic or carnivore diets also make everyone migraine free, provided they apply the nutritional changes well and titrate off all of their medications first, since there are some interactions between migraine medicines and the ketogenic diet. Titration is easy while on the Stanton Migraine Protocol(R).

      Medicines are not needed for a health-condition that is caused by eating foods one should not be eating. Just stop eating the stuff.

      In terms of me advertising my book: you bet! It is much cheaper to pay less than $10 for an e-book or less than $30 for a big paperback that gives you a solution for life, than to pay the copay for even a single Aimovig shot. And in exchange of spending the $10, you can become completely migraine free. So why wouldn’t I advertise it? Some of the migraine sufferers in my migraine group have saved in excess of $50,000 a year by not having to buy these medications and not needing to go to the ER for treatments. You can see some of the testimonials that I copy-pasted with permission from my closed Facebook group here.

      Have a lovely day,
      Angela

  19. Where can I find more info on increasing salt? I have Meniere’s disease as well as chronic migraines. Is it safe for me to increase salt? Thank you so much for this very useful information.

    • Hi Lena,

      There are many academic journal articles about salt now suggesting that the ideal sodium intake a day is between 4,000 and 6,000 mg for all people, healthy or sick. However, none of these articles is open to the public. The best places to find out about salt in general is in the book “The Salt Fix: Why the Experts Got It All Wrong–and How Eating More Might Save Your Life” by James DiNicolantonio (amazon linked) and more specifically for migraine and also Meniere’s disease, which is mentioned in the book, read my book “Fighting The Migraine Epidemic: Complete Guide: How to Treat & Prevent Migraines Without Medicines” by Angela A Stanton, PhD, also amazon- linked.

      The recommendation to reduce sodium consumption for Meniere’s disease comes from the understanding that salt retains water, which is true, except that salt doesn’t ever retain water outside of the cellular spaces in the body and the liquid in the case of Meniere’s disease is outside of the cells in a space where only air should be. Biologically the concept of keeping water there by salt is impossible so the theory is wrong. I work with many migraineurs who have Meniere’s disease who improved from increasing their salt consumption. You are welcome to join my Facebook migraine group, where we provide guidance.

      Best wishes,
      Angela

  20. Fascinating article. Much needed. Tysm for writing & sharing with us. I shared it with many fellow migraineurs. I’ll be looking into your work now, as I have suffered for years, but I’m getting better. Shine On, Angela! We need you!

  21. Every time I tell people about the benefits of salt, including doctors and other so called health providers, they look at me in disbelief, and sometimes even with anger. “How can you be so stupid, Roald”, is a common phrase leaving their mouth, followed by, “Too much salt is bad for you, Roald”. Of course I agree with them on “too much”, which eases a bit the mental pain and confusion I’ve caused them, and also gives them the uplifting feeling they’ve corrected my abominable take on salt. Well……um……till I tell them: “If you drink too much water, you could die.” ?

    Ah, already Petronius noticed: Mundus vult decipi, ergo decipiatur.

  22. Thanks for outlining the drug and its testing in such detail. Many migraneurs are being sold a false hope based on desperation and I have no doubt that many will be led to spend a ton on something that is only of minimal help, and may be far more damaging than we realize now. Long live healing ourselves by natural routes our bodies suggest (minerals, food, water) and thanks for pushing back against the sheep-like mentality that Big Pharma desires from chronic sufferers.

    • Thanks Kristina for your support. Indeed, drugs are big money business! Making money on false hope (very well put by you) is what health conditions/diseases are all about, even at the price of hurting migraineurs and others who are ill. Thanks for reading my article and thanks for helping migraine sufferers you work with by informing them.

      Best wishes,
      Angela

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