Categories
Change Password!
Reset Password!
With a favorable safety profile, Ubrogepant exhibits comparable effectiveness for the management of both perimenstrual and non-perimenstrual migraines.
A post hoc analysis depicted that Ubrogepant, an oral calcitonin gene-related peptide receptor antagonist, exhibits comparable efficacy in addressing both perimenstrual migraine (pmM) and non-pmM attacks. Additionally, no new safety issues were observed. Investigators aimed to assess the effectiveness and safety of Ubrogepant in treating pmM attacks.
Following completion of one of two phase 3 trials, subjects had the option to join a 52-week, open-label, phase 3, long-term safety extension trial. In this trial, they were re-randomized to one of three groups: standard care, Ubrogepant 50 mg, or Ubrogepant 100 mg, with an equal distribution (1:1:1). This study focused on evaluating the effectiveness of Ubrogepant in a specific subgroup of females who used Ubrogepant to treat at least one pmM or non-pmM attack.
A pmM attack was defined as occurring between two days prior and the initial three days of menstrual bleeding. The study reported the mean (standard deviation [SD]) of Ubrogepant-treated attacks that achieved 2-hour pain freedom and pain relief, with equal weight given to each volunteer's outcomes. Out of a total of 734 women in the modified intent-to-treat group, 354 women reported experiencing at least one menstrual cycle during which they also had a headache treated with Ubrogepant.
Among these, 278 women reported pmM attacks, and 716 reported non-pmM attacks. Pain relief within 2 hours was observed in a mean (SD) of 28.7% (37.4) of pmM attacks and 22.1% (26.9) of non-pmM when treated with a 50 mg dose of Ubrogepant. For the 100 mg dose, the percentages were 29.7% (35.2) for pmM attacks and 25.3% (26.3) for non-pmM attacks.
There was no considerable variation in the mean percentage of pmM and non-pmM attacks that attained 2-hour pain alleviation with either 100 mg (67.1% [37.4] vs. 68.4% [30.2]) or 50 mg (64.8% [39.9] vs. 65.2% [32.4]) of Ubrogepant. In the pmM subgroup, treatment-related adverse events occurred in 8.8% (12 out of 137) of individuals receiving the 50 mg dose and 12.8% (18 out of 141) of those receiving the 100 mg dose of Ubrogepant. Thus, Ubrogepant displayed comparable effectiveness in treating both pmM and non-pmM attacks, and there were no new safety concerns identified.
Headache
Safety and efficacy of ubrogepant for the acute treatment of perimenstrual migraine attacks: A post hoc analysis
E Anne MacGregor et al.
Comments (0)