NEW research has shown that anti-CGRP monoclonal antibodies (mAbs) are not associated with an increased cardiovascular disease (CVD) risk, compared to onabotulinumtoxinA among, Medicare beneficiaries with migraine.
This study evaluated the cardiovascular safety of anti-CGRP mAbs, a migraine-specific preventive therapy, in patients with high baseline cardiovascular risk. Concerns about the potential effects of CGRP blockade on cardiovascular outcomes were addressed using a cohort of 9,153 Medicare beneficiaries aged 18 years or older. Data from May 2018 to December 2020 were analysed retrospectively, with patients grouped based on their initiation of anti-CGRP mAbs or onabotulinumtoxinA. Exclusions included patients with prior myocardial infarction (MI), stroke, cluster headache, cancer, or those receiving hospice care within the baseline year. The primary endpoint was time to first MI or stroke, while secondary outcomes included hypertensive crises, peripheral revascularisation, and Raynaud phenomenon.
The study included 5,153 anti-CGRP mAb users (mean age 57.8 years, 83.6% female) and 4,000 onabotulinumtoxinA users (mean age 61.9 years, 83.8% female). Analysis showed no significant difference in the primary composite outcome of MI or stroke (adjusted hazard ratio [aHR], 0.88; 95% CI, 0.44-1.77). Similarly, no differences were found for hypertensive crises (aHR, 0.46; 95% CI, 0.14-1.55), peripheral revascularisation (aHR, 1.50; 95% CI, 0.48-4.73), or Raynaud phenomenon (aHR, 0.75; 95% CI, 0.45-1.24). Subgroup analyses across age and pre-existing cardiovascular conditions confirmed these findings.
In conclusion, the use of anti-CGRP mAbs does not appear to elevate cardiovascular risk in older adults or individuals with disability. These findings offer reassurance for clinicians prescribing these therapies to patients historically underrepresented in clinical trials. However, longer-term studies across diverse populations are needed to strengthen the evidence base. Clinicians should continue to individualise treatment decisions, balancing the benefits of migraine prevention against potential risks.
Katrina Thornber, EMJ
Reference
Yang S et al. Cardiovascular Safety of Anti-CGRP monoclonal antibodies in older adults or adults with disability with migraine. JAMA Neurol. 2025;DOI:10.1001/jamaneurol.2024.4537.
