- Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
- Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
- Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
- Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
- Discuss the effect that the migraine drug erenumab (Aimovig) has on blood pressure.
The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults.1 Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent microvascular vasodilator; blocking or deleting it has produced hypertensive effects in animals.2
A retrospective analysis of postmarketing reports submitted to the FDA Adverse Events Reporting System 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.
In contrast, a retrospective analysis of four randomized, double-blind, placebo-controlled clinical trials including 2443 patients did not finnd 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-jjmr (Vyepti), fremanezumab-vfrm (Aiovy), and galcanezumab-gnlm (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
- Erenumab (Aimovig) for migraine prevention. Med Lett Drugs Ther 2018; 60:101.
- Z Kee et al. The role of calcitonin gene related peptide (CGRP) in neurogenic vasodilation and its cardioprotective effects. Front Physiol 2018; 9:1249.
- S Saely et al. Hypertension: a new safety risk for patients treated with erenumab. Headache 2021; 61:202.
- D Kudrow et al. Vascular safety of erenumab for migraine prevention. Neurology 2020; 94:e497.
- Drugs for migraine. Med Lett Drugs Ther 2020; 62:153.