Assessing blood pressure changes and hypertension-related outcomes in patients with migraine treated with erenumab: A systematic review and meta-analysis.

Abstract

Objectives/background: We aimed to systematically review and summarize evidence on the effects of erenumab on systemic blood pressure (BP) in patients with migraine (International Prospective Register of Systematic Reviews ID: CRD42024571056). US Prescribing Information for erenumab was updated to include the potential risk of hypertension, although randomized trials did not link it previously. The association of this monoclonal antibody with an elevated vascular risk remains uncertain.

Methods: Embase, PubMed, and the Cochrane databases were searched up to June 18, 2024 for studies examining the impact of erenumab on BP in patients with migraine. I² statistics and prediction intervals (PIs) were applied to assess heterogeneity, and sensitivity and subgroup analyses were used to explore it. Data were collected using mean difference (MD) or proportion of events. The risk of bias of the included studies was assessed with the Cochrane Risk of Bias tool.

Results: Systolic (MD = 0.86, 95% confidence interval [CI] = -1.02 to 2.73, p = 0.370, I² = 63%) and diastolic (MD = 1.33, 95% CI = -0.05 to 2.72, p = 0.060, I² = 69%) BP measures did not significantly differ between after and before erenumab treatment. This lack of significant difference persisted at 3 and 12 months. The leave-one-out technique did not change heterogeneity. The proportion of participants presenting worsening BP appears to be 22.04% (95% CI = 11.12-38.98, PI = 0.54-93.60), with 56.40% corresponding to nonhypertensive individuals at baseline. The incidence of patients starting antihypertensive medications during the study was 3.96% (95% CI = 1.30-11.42, PI = 0.02-90.04), of which 62.88% corresponded to nonhypertensive patients at baseline.

Conclusion: We did not find an association of erenumab with significant increases in systemic BP. There is a considerable degree of fragility in the current evidence available. The decision to prescribe erenumab, especially for patients with multiple comorbidities and risk factors for hypertension, must be made weighing the risks and benefits. Further studies are needed to confirm these findings.