Long-term safety, efficacy and functional outcomes of atogepant for the preventive treatment of migraine
Abstract
AimLong-term data for oral calcitonin gene-related peptide receptor antagonist, atogepant, in episodic migraine (EM) has been reported. This is the first report on one-year outcomes in participants with chronic migraine (CM) and in the EM population with prior preventive treatment failures. Here, we report the long-term safety, tolerability, efficacy and functional outcomes of one-year preventive treatment of EM or CM with atogepant.MethodsThis is an interim analysis of an ongoing, open-label, multicenter, 156-week, safety extension study that enrolled completers from phase 3 PROGRESS and ELEVATE trials. The participants completing week 52 or early termination were evaluated. Eligible adults with at least a one-year history of migraine, with either CM (PROGRESS) or EM who previously had inadequate response to two to four classes of conventional oral preventive treatments (ELEVATE). All participants received atogepant 60 mg once daily. The primary outcome was safety and tolerability of atogepant. Efficacy and functional outcomes were prespecified exploratory analyses.ResultsOf 596 participants, 595 (PROGRESS, n = 325; ELEVATE, n = 270) were treated and included in the safety population and 524 (PROGRESS, n = 284; ELEVATE, n = 240) were included in the modified intent-to-treat population. In this interim analysis, mean duration of atogepant exposure was 496.5 days. Treatment-emergent adverse events (TEAEs) occurred in 79.0% of participants; most were mild/moderate and not…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 596 participants or records.
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