Efficacy and cardiovascular safety of lasmiditan in patients with cardiovascular risk factors: A systematic review and meta-analysis with updated synthesis of triptan safety data
Abstract
Objective: This study was conducted to evaluate lasmiditan efficacy and cardiovascular (CV) safety in patients with CV risk factors, and provide an updated synthesis of observational evidence on long-term triptan-related CV outcomes.
Background: Approximately 20% of patients with migraine have CV contraindications to triptans. Lasmiditan, a selective 5-hydroxytryptamine (5-HT)1F receptor agonist without vasoconstrictive properties, may offer a safer alternative to triptans for these patients.
Methods: In this systematic review and meta-analysis, we systematically searched MEDLINE, Embase, Scopus, and Cochrane CENTRAL from inception to June 2025 following a retrospectively registered International Prospective Register of Systematic Reviews protocol (CRD420251208584). Primary outcomes were pain freedom at 2 h (efficacy; randomized controlled trials) and major adverse CV events (observational studies). Random-effects meta-analyses used odds ratios (ORs) for binary efficacy outcomes and hazard ratios for time-to-event safety data. Rare cardiac adverse events were analyzed using Peto ORs. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework.
Results: Sixteen studies were included (six lasmiditan studies involving three randomized controlled trials [two phase 3 and one phase 2] enrolling 5126 participants, two post hoc analyses, one open-label extension, and 10 triptan CV safety studies). In the…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 5,126 participants or records.
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