Sumatriptan/Naproxen Sodium as Early Intervention for Migraine: Effects on Functional Ability, Productivity, and Satisfaction in 2 Randomized Controlled Trials

• Objective: To examine the effects of early intervention with sumatriptan/naproxen sodium for migraine on functional ability, productivity, and patient satisfaction. • Design: 2 randomized, double-blind, parallel-group studies. • Participants and setting: Migraineurs aged 18 to 65 years at 106 U.S. neurology and headache clinics treated with sumatriptan 85 mg formulated with RT technology/naproxen sodium 500 mg or placebo within 1 hour of pain onset. • Measurements: Functional ability on a 5-point scale through 4 hours postdose, migraine-associated disability time through 24 hours postdose, and satisfaction on the Revised Patient Perception of Migraine Questionnaire (PPMQ-R). • Results: Two and 4 hours postdose, approximately twice as many patients reported normal functional ability with sumatriptan/naproxen than placebo in each study (P < 0.001). Total disability time was 47% to 48% lower with sumatriptan/naproxen than placebo (2.7 versus 5.1 hours study 1; 2.7 versus 5.2 hours study 2; P < 0.001). Mean lost workplace productivity and lost nonworkplace activity time were lower with sumatriptan/naproxen than placebo (lost workplace productivity: 1.8 versus 3.1 hours study 1 [P < 0.001]; 1.7 versus 2.5 hours study 2 [P < 0.05]; lost nonworkplace activity time: 2.2 versus 4.1 hours study 1; 2.2 versus 4.3 hours study 2 [P < 0.001]). Mean satisfaction scores were significantly higher with sumatriptan/naproxen versus placebo for the efficacy, functionality, and ease of use subscales and the total score in both studies. • Conclusion: Sumatriptan/naproxen confers rapid, restoration of functional ability and productivity in migraine and receives high patient satisfaction ratings. Migraine is a common and disabling illness, affecting about 18% of U.S. women and 6% of men [1,2]. Migraines have long been recognized as a major cause of work absenteeism and decreased work productivity [3–7], with the cost of productivity losses estimated between $5.6 to $17 billion per year [7,8]. Headache disability also impacts the sufferer’s personal life and has been shown to reduce health-related quality of life [9]. Triptans are the mainstay of therapy for acute treatment of migraine, and their effectiveness has been well-established in controlled clinical trials. Sumatriptan has been shown to be effective in relieving headache and associated migrainous symptoms in long-term studies [10–12]. The positive effects of sumatriptan on health-related quality of life and productivity have also been established [13–15]. Naproxen has been available to consumers by prescription since 1976 and naproxen sodium has been available as an over-the-counter analgesic since 1994. Naproxen-containing products are indicated for multiple conditions, including arthritis and pain, but not migraine. To date, there have been no published large studies (> 200 adults) that have evaluated the effects of naproxen after long-term episodic use in any condition. Despite this, migraine treatment guidelines recommend use of nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line therapy [16]. A sumatriptan/naproxen sodium tablet containing sumatriptan 85 mg formulated with RT technology and naproxen sodium 500 mg (“sumatriptan/naproxen” henceforth) is being evaluated for the acute treatment of migraine. originAl reseArch From the Park Nicolett Headache Clinic & Research Center and University of Minnesota School of Medicine, Minneapolis, MN (Dr. Taylor); the Minneapolis Clinic of Neurology, Minneapolis, MN (Dr. Heiring); Michigan Headache Treatment Network, Lansing, MI (Dr. Messina); Braverman-Panza Medical Group, Albany, NY (Dr. Braverman-Panza); and GlaxoSmithKline, Research Triangle Park, NC (Drs. Ames and Burch, Mss. Bird and McDonald).