Long-term safety of CGRP pathway inhibitors in migraine patients with prior cerebrovascular or cardiovascular disease
Abstract
Background: Calcitonin gene-related peptide (CGRP) pathway inhibitors are highly effective migraine preventives, but their long-term cerebrovascular and cardiovascular safety in patients with prior ischaemic events remains uncertain, as such individuals were largely excluded from clinical trials.
Methods: We analysed data from a prospective real-world registry of migraine patients treated with CGRP pathway inhibitors at our tertiary Headache Centre. Patients with a history of ischaemic stroke, transient cerebral ischaemic attack, or ischaemic heart disease were included. Clinical characteristics, treatment response, and vascular outcomes were assessed during follow-up.
Results: Among 420 consecutive migraine patients treated with CGRP pathway inhibitors in our registry, 17 (4%) had a history of cerebrovascular and/or cardiovascular disease and met the inclusion criteria. These patients (median age 54.5 years, 76% female; 82% chronic migraine) contributed a total of 31 patient-years of exposure, with follow-up up to 5 years. Median time from event to treatment initiation was 5.0 years (IQR 4.5). 13 patients (76%) achieved ≥ 50% reduction in monthly migraine days (10/14 in chronic migraine; 3/3 in episodic migraine). No recurrent cerebrovascular events or worsening of underlying cardiac disease were observed during treatment. Serial neuroimaging, available in a subset, showed no new ischaemic lesions.
Conclusions: In this small real-world cohort patients with prior…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 420 participants or records.
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