AAN 2025 | A systematic review and meta-analysis of the cardiovascular safety of erenumab in migraine treatment

So in recent years, a new class of drugs targeting the calcitonin gene-related peptide pathway has emerged and transformed migraine treatment for sure. CGRP is a neurotransmitter with strong vasodilatory properties, and it is known to play a key role in migraine pathophysiology. And because of these properties, there were some theoretical concerns that blocking the CGRP or its receptor might lead to increased blood pressure. And while randomized controlled trials initially reported a good cardiovascular safety profile, we had some post-marketing data from the FDA reporting system and some real-world studies reporting that patients undergoing treatment with erenumab, a CGRP receptor monoclonal antibody, had increased blood pressure with clinically relevant outcomes for their lives, like the need for initiation of antihypertensive medication. So this conflicting evidence motivated us to conduct a systematic review and meta-analysis to better understand whether erenumab affects systemic blood pressure in patients undergoing treatment. We followed the Cochrane Handbook for Interventional Systematic Reviews and the PRISMA guidelines. We conducted systematic searches in PubMed, Embase and Cochrane databases for randomized controlled trials or real-world studies that reported changes in blood pressure or related outcomes such as the proportion of patients initiating antihypertensive medications during the study conduction. We applied a random effects model in order to take into account the inclusion of non-randomized data, and we conducted subgroup analysis and sensitivity analysis to better explore the heterogeneity between studies. After the full-test screening, we included 10 studies encompassing around 3,000 migraine patients treated with this monoclonal antibody, and our findings showed that no significant changes were found in systolic or diastolic blood pressure even after 3 or 12 months of treatment. And we also found that the incidence of patients starting antihypertensive medication was around 4%, which is not a big number, and most of these patients didn’t have a hypertension diagnosis at baseline. When we were doing the systematic review, the qualitative review, we found one important observation that is that few studies in the literature that were included in the systematic review, they focus on higher risk populations like older adults or patients with multiple comorbidities. We know that migraine is associated with a higher risk for cardiovascular and cerebrovascular and psychiatric conditions, so this is very important because that’s the real situation in migraine patients. So we have a subgroup of migraineurs that are not generally included in the randomized controlled trials, they usually are excluded by the criteria, and it therefore limits the generalizability of our findings. Our conclusion was that erenumab does not appear to significantly raise blood pressure in migraine patients, but further well-designed studies, especially encompassing this at-risk population, are really needed. And until then, we believe an individualized and case-by-case approach is the most prudent action when deciding to prescribe or not erunemab.

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