Richard B. Lipton, M.D., from Albert Einstein College of Medicine and the Montefiore Headache Center in New York City, and colleagues evaluated the efficacy and safety of atogepant for the preventive treatment of migraine from Dec. 14, 2018, to June 19, 2020, in adults seen at 128 U.S. sites with four to 14 migraine-days per month. Analysis included patients randomly assigned to 10 mg of atogepant (214 patients), 30 mg of atogepant (223 patients), 60 mg of atogepant (222 patients), or placebo (214 patients) once daily in 12 weeks.
The researchers found that a ≥50 percent reduction in the mean of mean monthly migraine-day (MMD) was achieved by 55.6 percent treated with 10 mg of atogepant (odds ratio, 3.1), 58.7 percent treated with 30 mg atogepant (odds ratio, 3.5), 60.8 percent treated with 60 mg of atogepant (odds ratio, 3.8), and 29 percent receiving placebo. A ≥25 percent reduction in the 12-week mean of MMDs was achieved by 73.4, 77.1, 81.1, and 58.9 percent, respectively, while a ≥75 percent reduction in mean MMDs was achieved by 30.4, 29.6, 37.8, and 10.7 percent, respectively. A 100 percent reduction in mean MMDs was achieved for 7.9 percent with 10 mg, 4.9 percent for 30 mg, and 7.7 percent for 60 mg of atogepant versus 0.9 percent with placebo.
“At all doses, atogepant was effective during the 12-week double-blind treatment period beginning in the first 4 weeks, as evidenced by significant reductions in mean MMDs at every responder threshold level,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Allergan, which manufactures atogepant and funded the study.