Nonspecific oral medications versus anti–calcitonin gene‐related peptide monoclonal antibodies for migraine: A systematic review and meta‐analysis of randomized controlled trials

降钙素基因相关肽 偏头痛 荟萃分析 医学 降钙素 单克隆抗体 随机对照试验 内科学 单克隆 药理学 抗体 免疫学 神经肽 受体
作者
Jennifer Robblee,Sameh M. Hakim,John Reynolds,Teshamae Monteith,Niushen Zhang,Meredith Barad
出处
期刊:Headache [Wiley]
卷期号:64 (5): 547-572 被引量:2
标识
DOI:10.1111/head.14693
摘要

Abstract Objective To compare calcitonin gene–related peptide monoclonal antibodies (CGRP mAbs) versus nonspecific oral migraine preventives (NOEPs). Background Insurers mandate step therapy with NOEPs before approving CGRP mAbs. Methods Databases were searched for class I or II randomized controlled trials (RCTs) comparing CGRP mAbs or NOEPs versus placebo for migraine prevention in adults. The primary outcome measure was monthly migraine days (MMD) or moderate to severe headache days. Results Twelve RCTs for CGRP mAbs, 5 RCTs for topiramate, and 3 RCTs for divalproex were included in the meta‐analysis. There was high certainty that CGRP mAbs are more effective than placebo, with weighted mean difference (WMD; 95% confidence interval) of −1.64 (−1.99 to −1.28) MMD, which is compatible with small effect size (Cohen's d −0.25 [−0.34 to −0.16]). Certainty of evidence that topiramate or divalproex is more effective than placebo was very low and low, respectively (WMD −1.45 [−1.52 to −1.38] and −1.65 [−2.30 to −1.00], respectively; Cohen's d −1.25 [−2.47 to −0.03] and −0.48 [−0.67 to −0.29], respectively). Trial sequential analysis showed that information size was adequate and that CGRP mAbs had clear benefit versus placebo. Network meta‐analysis showed no statistically significant difference between CGRP mAbs and topiramate (WMD −0.19 [−0.56 to 0.17]) or divalproex (0.01 [−0.73 to 0.75]). No significant difference was seen between topiramate or divalproex (0.21 [−0.45 to 0.86]). Conclusions There is high certainty that CGRP mAbs are more effective than placebo, but the effect size is small. When feasible, CGRP mAbs may be prescribed as first‐line preventives; topiramate or divalproex could be as effective but are less well tolerated. The findings of this study support the recently published 2024 position of the American Headache Society on the use of CGRP mAbs as the first‐line treatment.
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