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Safety and efficacy of ubrogepant for the acute treatment of perimenstrual migraine attacks: A post hoc analysis.
- Source :
- Headache: The Journal of Head & Face Pain; Sep2023, Vol. 63 Issue 8, p1135-1144, 10p
- Publication Year :
- 2023
-
Abstract
- Objective: To evaluate the efficacy and safety of ubrogepant for the acute treatment of perimenstrual migraine (pmM) attacks. Background: Ubrogepant is an oral calcitonin gene‐related peptide receptor antagonist approved for the acute treatment of migraine in adults. Methods: After completing one of two phase 3 trials, participants could enroll in a phase 3, 52‐week, open‐label, long‐term safety extension trial and were re‐randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg. This post hoc analysis evaluated the efficacy of ubrogepant in a subset of women who treated ≥1 pmM or non‐pmM attack with ubrogepant. A pmM attack started on or between 2 days before and the first 3 days of menstrual bleeding. Mean (standard deviation [SD]) percentages of ubrogepant‐treated attacks achieving 2‐h pain freedom and pain relief were reported, with outcomes weighted equally by participant. Results: Of 734 women in the modified intent‐to‐treat population, 354 reported ≥1 menstrual cycle start date and a ubrogepant‐treated headache day in the same month. A qualifying pmM and non‐pmM attack was reported by 278 and 716 women, respectively. Pain freedom at 2 h was achieved in a mean (SD) of 28.7% (37.4) of pmM attacks and 22.1% (26.9) of non‐pmM attacks treated with ubrogepant 50 mg (p = 0.054) and 29.7% (35.2) versus 25.3% (26.3) of attacks treated with ubrogepant 100 mg (p = 0.757). No difference was found in the mean percentage of ubrogepant‐treated pmM and non‐pmM attacks that achieved 2‐h pain relief with ubrogepant 50 mg (64.8% [39.9] vs. 65.2% [32.4]; p = 0.683) and with 100 mg (67.1% [37.4] vs. 68.4% [30.2]; p = 0.273). Treatment‐related treatment‐emergent adverse events were reported by 8.8% (12/137) and 12.8% (18/141) in the ubrogepant 50 and 100 mg pmM subgroups, respectively. Conclusions: Ubrogepant demonstrated similar efficacy for the treatment of pmM and non‐pmM attacks. No new safety signals were identified. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00178748
- Volume :
- 63
- Issue :
- 8
- Database :
- Complementary Index
- Journal :
- Headache: The Journal of Head & Face Pain
- Publication Type :
- Academic Journal
- Accession number :
- 172021879
- Full Text :
- https://doi.org/10.1111/head.14619