Four CGRP drugs have been approved for migraine prevention. Three of the drugs, Erenumab (Aimovig), Fremanezumab(Ajovy), and (galcanezumab) Emgality are given once every month by self administered subcutaneous injection. Eptinezumab (Vyepti) is a similar drug delivered by IV infusion. They all work well for preventing migraine with few side effects.

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However, Erenumab has been implicated as possibly causing high blood pressure.

This is an article by Britt Talley Daniel MD, retired member of the American Academy of Neurology, Migraine textbook author, Podcaster, YouTube video producer, and Blogger.

Additional questions:

Has the FDA reacted to the hypertension problem with Erenumab (Aimovig)?

Aimovig is a once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist. It was approved by the FDA in 1918 for preventive treatment of migraine in adults, but in April 2021 the FDA added a warning to its labeling about risk of new onset hypertension and worsening of preexisting hypertension associated with use of the drug.

How does Erenumab (Aimovig) work?

Erenumab (Aimovig) blocks the CGRP receptor, it is a microvascular vasodilator. Erenumab (Aimovig) has produced hypertensive effects in animals.

What accepted side effects does Erenumab (Aimovig) have?

Possible side effects are:

hypersensitivity reaction

injection site reaction-bruising

constipation

muscle cramps or spasms

What reports have shown hypertension from Erenumab (Aimovig)?

The Medical Letter on Drugs Therapy. 2021 Apr 5;63(1621):56 reported a retrospective analysis of post marketing reports submitted to the FDA Adverse Events Reporting System. They identified 61 cases of elevated blood pressure associated with erenumab use, of which 41 were considered serious and 7 required hospitalization.

Many cases occurred in patients with preexisting hypertension or risk factors for hypertension such as age ≥65 years, dyslipidemia, and diabetes. The median reported increases in systolic and diastolic blood pressure were 39 and 28 mm Hg, respectively.

Most cases were associated with the first or second dose of erenumab. Of the 44 cases in which time to onset was reported, 28 occurred ≤7 days after the most recent dose. Hypertension was reported both with and without concurrent triptan use.3 One Medical Letter reviewer reported a case of hypertension that persisted for >3 months after stopping erenumab, even with use of antihypertensive therapy.

Is there controversy regarding Erenumab (Aimovig) aggravating hypertension?

In contrast, a retrospective analysis of four randomized, double-blind, placebo-controlled clinical trials including 2443 patients did not find an association between erenumab use and hypertension or vascular events; these trials excluded patients who had experienced a serious cardiovascular event in the previous 12 months.4

Eptinezumab (Vyepti), fremanezumab (Aiovy), and galcanezumab (Emgality), the other CGRP antagonists approved by the FDA for migraine prevention, block CGRP itself rather than its receptors. Their labels do not contain warnings about a risk of hypertension. Patients with significant cardiovascular risk factors were also excluded from clinical trials of these agents.5

Another article published in Headache. 2021 Oct;61(9):1411-1420. doi: 10.1111/head.14208. Epub 2021 Sep 30 was entitled:

Risk of hypertension in erenumab-treated patients with migraine: Analyses of clinical trial and postmarketing data

David W Dodick 1, Stewart J Tepper 2, Jessica Ailani 3, Nicola Pannacciulli 4, Marco S Navetta 4, Brett Loop 5, Feng Zhang 4, Ani C Khodavirdi 4, Allison Mann 6, Ahmad Abdrabboh 6, Jawed Kalim 6

Objective: To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting.

Background: Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting.

Methods: Safety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020.

Results: In the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years.

Conclusions: Clinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab.

Final analysis

The statement above from America’s top Migraine experts states the current situation that ”Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab.”

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All the best.

Britt Talley Daniel MD