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Abstract

Prospective real-world data comparing all major migraine drug classes are scarce in low- and middle-income countries; Iraq offers an opportune setting given expanding access to gepants and lasmiditan. To compare 24-week efficacy, tolerability, and medication overuse headache (MOH) risk across triptans, gepants, lasmiditan, and valproate in Iraqi migraineurs, and to identify independent predictors of optimal response. This prospective cohort study (February–August 2024) enrolled 247 patients at four Baghdad tertiary headache clinics. Four primary drug groups (triptans n=110, gepants n=46, lasmiditan n=38, valproate n=35; N=229) were compared by ANOVA; a smaller simple-analgesics cohort (n=18) was analysed descriptively. Monthly migraine days (MMD), visual analogue scale (VAS), and HIT-6 were assessed at baseline, 12, and 24 weeks. Ethical approval was obtained (Approval No. 238); retrospective ISRCTN registration is in progress. At 24 weeks, gepants achieved the lowest residual MMD (3.9±2.4 days/month), VAS (3.8±1.4), and HIT-6 (47.8±6.8), significantly better than triptans (P<0.05). Two-hour pain freedom did not differ significantly among triptans, gepants, and lasmiditan after correction for multiple comparisons. Gepant use was the strongest independent predictor of optimal response (≥50% MMD reduction: OR=2.66, 95% CI 1.20–5.89; ≥30%: OR=2.41, 95% CI 1.12–5.19), robust across sensitivity analyses and E-value analysis at both thresholds (E=4.25–4.76). Gepants and lasmiditan showed no MOH signal. The Composite Migraine Control Score (CMCS) ranked gepants highest (76.0/100). In this first concurrent 24-week comparison of four migraine drug classes in the MENA region, gepants showed superior control, best tolerability, and lowest MOH risk. Confirmatory trials and external validation of the novel CMCS are needed‎.

Keywords: Migraine, Gepants, CGRP receptor antagonist, Triptans, Lasmiditan, Valproate

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