Clinical Trials Report: Sumatriptan–Naproxen Combination for Symptomatic Treatment of Comorbid Dysmenorrhea and Migraine

Abstract

Dysmenorrhea and headache are common menstrual disorders, affecting millions of women worldwide. Both of these conditions are associated with significant disability resulting in work or school absenteeism and substantially impaired quality of life. Migraine is a recurrent headache disorder estimated to affect at least 15% of the population, and is defined as episodic headaches lasting 4 to 72 h, accompanied by photophobia, phonophobia, nausea and vomiting, and restricted activity [1]. The condition is more prevalent in women than in men, with 4 of every 10 women experiencing migraine in their lifetime, most before the age of 35 years [2]. In population-based studies, around 50% of women with migraine report an association between migraine and menstruation [3]. The peak incidence of migraine during the menstrual cycle is on or between 2 days before the onset of menstrual flow and the first 3 days of bleeding [4]. The term menstrual migraine is used to describe attacks that regularly occur at this time [1]. Primary dysmenorrhea is the occurrence of painful menstrual cramps of uterine origin in the absence of pathology. The exact prevalence is unclear, although it is probable that most women experience dysmenorrhea at some time during their reproductive years. Cramps usually develop within hours of the start of menstruation and peak during the first 48 to 72 h of the cycle, when the flow becomes heaviest. Naproxen is an NSAID. NSAIDs are non-narcotic analgesics recommended as first-line treatment for primary dysmenorrhea, relieving symptoms in up to 70% of women [5]. Naproxen also is effective for the management of moderate to severe migraine, reducing headache intensity, rendering patients pain-free at 2 h, and improving migraineassociated symptoms [6]. Sumatriptan was the first triptan to be developed of seven triptans currently available, with established efficacy for symptomatic treatment of migraine [7]. The sumatriptan–naproxen sodium combination (sumatriptan, 85 mg, formulated with RT Technology, and naproxen sodium, 500 mg, in a single-tablet formulation [Treximet; GlaxoSmithKline, Research Triangle Park, NC]) is a more recent advance for symptomatic treatment of migraine and has been shown to be more effective in restoring normal function following treatment than either sumatriptan or naproxen sodium alone [8]. Prostaglandins have been implicated in the pathophysiology of both menstrual migraine and dysmenorrhea, E. A. MacGregor The City of London Migraine Clinic, 22 Charterhouse Square, London EC1M 6DX, UK