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Atogepant for the Preventive Treatment of Migraine.
Ailani, Jessica; Lipton, Richard B; Goadsby, Peter J; Guo, Hua; Miceli, Rosa; Severt, Lawrence; Finnegan, Michelle; Trugman, Joel M.
  • Ailani J; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Lipton RB; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Goadsby PJ; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Guo H; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Miceli R; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Severt L; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Finnegan M; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
  • Trugman JM; From MedStar Georgetown University Hospital, Washington, DC (J.A.); Albert Einstein College of Medicine and Montefiore Headache Center, New York (R.B.L.); the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London (P.J.G.); the Departme
N Engl J Med ; 385(8): 695-706, 2021 08 19.
Article in English | MEDLINE | ID: covidwho-1364626
ABSTRACT

BACKGROUND:

Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist that is being investigated for the preventive treatment of migraine.

METHODS:

In a phase 3, double-blind trial, we randomly assigned adults with 4 to 14 migraine days per month in a 1111 ratio to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks. The primary end point was the change from baseline in the mean number of migraine days per month across the 12 weeks. Secondary end points included headache days per month, a reduction from baseline of at least 50% in the 3-month average of migraine days per month, quality of life, and scores on the Activity Impairment in Migraine-Diary (AIM-D).

RESULTS:

A total of 2270 participants were screened, 910 were enrolled, and 873 were included in the efficacy analysis; 214 were assigned to the 10-mg atogepant group, 223 to the 30-mg atogepant group, 222 to the 60-mg atogepant group, and 214 to the placebo group. The mean number of migraine days per month at baseline ranged from 7.5 to 7.9 in the four groups. The changes from baseline across 12 weeks were -3.7 days with 10-mg atogepant, -3.9 days with 30-mg atogepant, -4.2 days with 60-mg atogepant, and -2.5 days with placebo. The mean differences from placebo in the change from baseline were -1.2 days with 10-mg atogepant (95% confidence interval [CI], -1.8 to -0.6), -1.4 days with 30-mg atogepant (95% CI, -1.9 to -0.8), and -1.7 days with 60-mg atogepant (95% CI, -2.3 to -1.2) (P<0.001 for all comparisons with placebo). Results for the secondary end points favored atogepant over placebo with the exceptions of the AIM-D Performance of Daily Activities score and the AIM-D Physical Impairment score for the 10-mg dose. The most common adverse events were constipation (6.9 to 7.7% across atogepant doses) and nausea (4.4 to 6.1% across atogepant doses). Serious adverse events included one case each of asthma and optic neuritis in the 10-mg atogepant group.

CONCLUSIONS:

Oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks. Adverse events included constipation and nausea. Longer and larger trials are needed to determine the effect and safety of atogepant for migraine prevention. (Funded by Allergan; ADVANCE ClinicalTrials.gov number, NCT03777059.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Piperidines / Pyridines / Pyrroles / Spiro Compounds / Calcitonin Gene-Related Peptide Receptor Antagonists / Migraine Disorders Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Variants Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Piperidines / Pyridines / Pyrroles / Spiro Compounds / Calcitonin Gene-Related Peptide Receptor Antagonists / Migraine Disorders Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Variants Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: N Engl J Med Year: 2021 Document Type: Article