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Background <p>Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway and small-molecule CGRP receptor antagonists (gepants) are increasingly used as first-line preventive therapy for migraine. CGRP is a potent endogenous vasodilator with putative cardioprotective effects, and its sustained blockade has prompted concern regarding cardiovascular and cerebrovascular adverse events, particularly among patients with pre-existing vascular risk factors who were largely excluded from pivotal trials.</p> Objectives <p>To systematically synthesise randomised and non-randomised evidence on the incidence of major adverse cardiovascular events (MACE), cerebrovascular events, hypertension, and changes in blood pressure associated with anti-CGRP monoclonal antibodies and gepants compared with placebo, standard preventive therapy, or onabotulinumtoxinA in adults with migraine and pre-existing vascular risk factors.</p> Methods <p>This protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 statement and has been prospectively registered with PROSPERO (CRD420261385216). MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, Scopus, and ClinicalTrials.gov will be searched from 1 January 2014 to the search date. Two reviewers will independently screen records, extract data, and assess risk of bias using RoB 2 (randomised trials) and ROBINS-I (non-randomised studies). Random-effects meta-analyses will pool risk ratios and mean differences where data permit; otherwise, findings will be synthesised narratively following Synthesis Without Meta-analysis (SWiM) guidance. Certainty of evidence will be rated using GRADE.</p> Discussion <p>The review will synthesise available evidence on the cardiovascular and cerebrovascular safety of CGRP-targeted therapies in a clinically relevant subgroup that is under-represented in registration trials. Where data are sufficient to support quantitative pooling, summary estimates will be generated; where the evidence base is sparse, findings will be reported narratively following SWiM guidance. The results are intended to inform prescribing decisions and shared decision-making.</p> Registration <p>PROSPERO: CRD420261385216.</p>

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Cardiovascular and Cerebrovascular Safety of Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Gepants for the Preventive Treatment of Migraine in Patients with Pre-Existing Vascular Risk Factors: a Systematic Review and Meta-Analysis Protocol

  • 期刊论文

  • 发表日期：

    2026年6月3日

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  • Ravi Shankar,
  • Amaevia Lim,
  • Qian Xu

摘要

Background

Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway and small-molecule CGRP receptor antagonists (gepants) are increasingly used as first-line preventive therapy for migraine. CGRP is a potent endogenous vasodilator with putative cardioprotective effects, and its sustained blockade has prompted concern regarding cardiovascular and cerebrovascular adverse events, particularly among patients with pre-existing vascular risk factors who were largely excluded from pivotal trials.

Objectives

To systematically synthesise randomised and non-randomised evidence on the incidence of major adverse cardiovascular events (MACE), cerebrovascular events, hypertension, and changes in blood pressure associated with anti-CGRP monoclonal antibodies and gepants compared with placebo, standard preventive therapy, or onabotulinumtoxinA in adults with migraine and pre-existing vascular risk factors.

Methods

This protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 statement and has been prospectively registered with PROSPERO (CRD420261385216). MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, Scopus, and ClinicalTrials.gov will be searched from 1 January 2014 to the search date. Two reviewers will independently screen records, extract data, and assess risk of bias using RoB 2 (randomised trials) and ROBINS-I (non-randomised studies). Random-effects meta-analyses will pool risk ratios and mean differences where data permit; otherwise, findings will be synthesised narratively following Synthesis Without Meta-analysis (SWiM) guidance. Certainty of evidence will be rated using GRADE.

Discussion

The review will synthesise available evidence on the cardiovascular and cerebrovascular safety of CGRP-targeted therapies in a clinically relevant subgroup that is under-represented in registration trials. Where data are sufficient to support quantitative pooling, summary estimates will be generated; where the evidence base is sparse, findings will be reported narratively following SWiM guidance. The results are intended to inform prescribing decisions and shared decision-making.

Registration

PROSPERO: CRD420261385216.