Erenumab for Migraine Does Not Increase Cardiovascular, Cerebrovascular Risk

Use of erenumab does not increase the risk for cardiovascular or cerebrovascular events compared with use of other migraine preventive medications, according to study results published in the journal Headache.

Migraine affects more than 10% of the global population and is linked to a higher risk for cardiovascular diseases, including myocardial infarction (MI) and stroke. Although erenumab — a human monoclonal antibody (mAb) against the calcitonin gene-related peptide (CGRP) receptor — has shown efficacy in patients with migraine, the CGRP pathway not only plays a key role in migraine pathophysiology but is also involved in vascular function. Therefore, use of erenumab may increase the risk for cardiovascular events. Preclinical and clinical trials have not indicated significant cardiovascular risks with erenumab, but real-world long-term safety data remain limited.

To address this knowledge gap, investigators conducted a retrospective observational cohort study using data from the MarketScan Commercial and Medicare Supplemental medical claims database. They analyzed outcomes for 108,019 patients who received migraine preventive medications, including erenumab, other anti-CGRP mAbs (galcanezumab-gnlm, fremanezumab-vfrm, and eptinezumab-jjmr), standard oral preventive medications, and onabotulinumtoxinA. The investigators assessed the cumulative risk (CR) for new-onset hypertension, MI, and stroke, employing comparative analyses to estimate relative risk (RR) of vascular events while controlling for confounding factors through inverse probability weighting and negative control outcome analyses.

At 12 months, the unadjusted CR for hypertension was similar across treatment groups: erenumab (CR, 9.34%; 95% CI, 8.79-9.89%), other anti-CGRP mAbs (CR, 9.42%; 95% CI, 8.92-9.92%), standard oral preventive medications (CR, 9.09%; 95% CI, 8.77-9.41%), and onabotulinumtoxinA (9.10%; 95% CI, 8.39-9.81%).

At 36 months, the adjusted RR for MI with erenumab vs other anti-CGRP mAbs was 1.02 (95% CI, 0.45-1.59), and with erenumab vs onabotulinumtoxinA was 0.87 (95% CI, 0.19-1.55). The adjusted RR for stroke was 0.90 (95% CI, 0.56-1.25) with erenumab vs other anti-CGRP mAbs and 0.97 (95% CI, 0.42-1.52) with erenumab vs onabotulinumtoxinA. Results were consistent across different patient subgroups, including those with and without a history of cardiovascular disease or migraine aura.

At 36 months, the cumulative risk for MI and stroke remained low across all treatment groups, with no significant differences between erenumab and comparator treatments.

Limitations of the study include reliance on medical claims data, which may contain misclassification errors or incomplete information on patient adherence to treatment. Additionally, while statistical adjustments were applied, residual confounding remains a possibility.

The investigators concluded, “In this analysis of the MarketScan medical claims database, we found no difference in the risk of vascular events in patients treated with erenumab versus other anti-CGRP pathway mAbs or onabotulinumtoxinA.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

This article originally appeared on Clinical Pain Advisor