Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium

Abstract

Background: Dysmenorrhea and menstrual migraine may share a common pathogenic pathway. Both appear to be mediated, in part, by an excess of prostaglandin production that occurs during menstruation.

Methods: Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms.

Results: Sumatriptan-naproxen was superior to placebo for relief of tiredness, irritability, and abdominal pain at the time periods of 2, 4, and 4-24 hours (p≤0.023); back pain at the time periods of 4 and 4-24 hours (p≤0.023); and bloating at 4-24 hours endpoint (p=0.01). The odds ratios (ORs) of attaining migraine pain freedom for 2 hours and for sustained 2-24 hours decreased as moderate to severe dysmenorrhea symptoms increased with sumatriptan-naproxen versus placebo.

Conclusions: Treatment with sumatriptan-naproxen may provide relief of menstrual symptoms and migraine in female migraineurs with dysmenorrhea. The presence of moderate to severe dysmenorrhea symptoms is associated with decreased response rates for menstrual migraine, suggesting that the co-occurrence of these disorders may negatively impact the results of migraine-abortive therapy.

Trial registration: ClinicalTrials.gov NCT00329355 NCT00329459.

Figures

FIG. 1.

Disposition of participants in the pooled analysis.

FIG. 2.

Menstrual symptom relief at 1, 2, 4, and 4–24 hours posttreatment.

FIG. 3.

Odds ratios for pain-free response versus number of moderate to severe menstrual symptoms at 30 minutes: sumatriptan-naproxen versus placebo.

FIG. 4.

Odds ratios for sustained pain-free response versus number of moderate to severe menstrual symptoms at 30 minutes: sumatriptan-naproxen versus placebo.