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On August 4, 2023 we reported on a study published in Lancet Neurology that examined the safety, tolerability, and efficacy of atogepant 30 mg taken twice daily and 60 mg taken once daily.
The randomized, double-blind, placebo-controlled trial was conducted at 142 international sites and enrolled adults aged 18 to 80 years with at least a 1-year history of chronic migraine with age of onset before age 50 years. Investigators randomly assigned eligible participants in 1:1:1 ratio to receive oral atogepant 30 mg twice a day, oral atogepant 60 mg once a day, or placebo for 12 weeks. The study's primary efficacy endpoint was defined as change in monthly migraine days (MMD) from baseline to end of treatment period and was analyzed in the modified intent to treat population. The safety population was comprised of all participants who received at least 1 dose of a study drug or placebo.
The researchers assessed potential participants for eligibility between March 11, 2019, and January 20, 2022, and the final cohort numbered 778. Researchers reported that 84 participants left the trial with the modified intent-to-treat population comprised of 755 participants n (atogepant 30 mg twice a day n=253, atogepant 60 mg once a day n=256, and placebo n=246).
The investigators reported that change from the baseline MMDs over the 12-week study period was −7.5 (SE 0.4) with atogepant 30 mg twice daily, −6.9 (0.4) with atogepant 60 mg once daily, and −5.1 (0.4) with placebo. The calculated least squares mean difference from placebo was −2.4 with atogepant 30 mg twice daily (95% CI −3.5 to −1.3; adjusted P<.001) and −1.8 with atogepant 60 mg once daily (−2.9 to −0.8; adjusted P=.0009).
Investigators also observed significant reductions in mean number of days a month when acute medication was used as well as clinically significant improvements over placebo in patient reported outcomes.
"Atogepant 30 mg twice a day and 60 mg once a day showed clinically relevant reductions in MMDs across 12 weeks in chronic migraine patients. Both atogepant doses were well tolerated, consistent with the known safety profile of atogepant."