Weight loss with atogepant in the long-term treatment of migraine: An interim analysis of a safety endpoint from a phase 3, multicenter, open-label, 156-week extension study
Abstract
Objective: To assess weight loss with atogepant 60 mg once daily during long-term treatment of chronic migraine (CM) and episodic migraine (EM) among participants previously failed by two to four classes of conventional oral preventive medications.
Background: The risk of migraine, including CM, in individuals with obesity is higher than in those without obesity. Calcitonin gene-related peptide has been linked to the pathophysiology of both obesity and migraine. Weight loss with atogepant, a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine, has been observed during the 12-week EM and CM trials, as well as in long-term (40- or 52-week) EM trials. Long-term effects of atogepant on body weight in participants with increased migraine burden (i.e., EM or CM) have not been reported.
Methods: In this interim analysis of a safety endpoint from study 312, a phase 3, open-label, extension study, weight loss was assessed in the overall population and by prior participation in each lead-in study (12-week double-blind treatment period): PROGRESS (phase 3, multicenter, randomized, controlled study in CM) or ELEVATE (phase 3, multicenter, randomized, controlled study in EM treatment failure). Change from baseline in body weight at each study visit through end of treatment (PROGRESS and ELEVATE) or up to week 52 (study 312) was assessed (safety endpoint). Proportions of participants with ≥5% weight loss at any time, at the end of the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 595 participants or records.
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