Aimovig™: A Miracle Migraine Treatment or Unnecessary Risk?

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Aimovig versus salt
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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37 Comments

  1. 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!

    1. 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

      1. 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!

        1. 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

  2. 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…?

    1. 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

  3. 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?

    1. 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

  4. 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.

    1. 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

  5. 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!

    1. 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

  6. 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.

    1. 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

  7. 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.

    1. 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

  8. 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.

    1. 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

  9. 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.

    1. 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

  10. 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

    1. 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

  11. 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.

    1. 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

  12. 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.

    1. 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

  13. 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.

    1. 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

  14. 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!

  15. 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.

  16. 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.

    1. 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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