Oral celecoxib is more effective than placebo for the treatment of acute migraine with or without aura, according to a pooled analysis of data from 2 clinical trials presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, held from June 9-12, in Denver, Colorado, and virtually.
Some treatments for acute migraine have differing efficacy among patients with aura and those without aura. In previous studies, celecoxib, a cyclooxygenase-2-selective nonsteroidal anti-inflammatory drug, was found to be more effective than placebo, but it remains unclear whether it is more effective for aura-associated migraine or migraine without aura.
This post-hoc analysis evaluated whether celecoxib was effective among patients with and without aura. In the double-blind, randomized, placebo-controlled trials (ClinicalTrials.gov Identifier: NCT03009019 and NCT03006276), patients (N=1075) experiencing a single migraine attack of moderate to severe intensity received 120 mg/4.8 mL oral solution of celecoxib or placebo. Patients were evaluated for 2-hour outcomes.
Patients were aged mean 44.5 years and 86.4% were women. Patient groups with (n=595) and without (n=480) aura were well balanced, comprising 71.8%-76.6% White individuals, the most frequent number of monthly migraine attacks was 4 (22.4%-29.0%), and 22.4%-32.9% reported nausea, 15.7%-25.2% phonophobia, and 41.9%-61.7% photophobia as the most bothersome symptom. A total of 301 of the patients with aura and 249 of the patients without aura received celecoxib.
At 2 hours, celecoxib was more effective than placebo for freedom from pain among those with (36% vs 25%; P <.001) and without (31% vs 21%; P <.001) aura, for freedom from most bothersome symptom among those with (57% vs 43%; P <.001) and without (58% vs 44%; P <.001) aura, and for pain relief among those with (74% vs 61%; P <.001) and without (68% vs 56%; P <.001) aura, respectively.
In a regression model analysis, no significant aura interaction terms were observed, indicating that celecoxib was similarly effective among both patients with and without aura.
This post hoc analysis found that “celecoxib oral solution 120 mg was more effective than placebo whether subjects treating attacks in trial had a history of aura or not,” the researchers concluded.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Tepper SJ, Serrano D, Iaconangelo C, Lipton RB. Treatment effects of celecoxib oral solution in migraine with aura and without aura: Post-hoc analysis of results from two randomized, double-blind placebo-controlled trials. Presented at: AHS 2022 Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado. Poster 206.