Consistency of response to sumatriptan-naproxen sodium in a placebo-controlled, crossover study

Lipton RB, Dodick DW, Adelman JU, Kaniecki RG, Lener SE, White JD & Nelsen AC. Consistency of response to sumatriptan-naproxen sodium in a placebo-controlled, crossover study. Cephalalgia 2009. London. ISSN 0333-1024 Two identical randomized, placebo-controlled, crossover studies were conducted to evaluate consistency of response to sumatriptan-naproxen sodium 85-500 mg (S-NS) over four attacks in adults with migraine. Patients were instructed to treat within 1 h of pain onset while pain was mild. Co-primary end-points were pain-free response at 2 h (2hPF) and 24-h sustained pain-free response (24hSPF) calculated as percentages of all attacks. In Study 1, 570 patients treated 1693 attacks with S-NS and 424 with placebo. In Study 2, 565 patients treated 1678 attacks with S-NS and 422 with placebo. Compared with placebo, S-NS conferred higher 2hPF rates (Study 1: S-NS 52%, placebo 25%; Study 2: S-NS 50%, placebo 20%; both P < 0.001) and higher 24hSPF rates (Study 1: S-NS 37%, placebo 17%; Study 2: S-NS 34%, placebo 12%; both P < 0.001). 2hPF was reported in at least two of the first three S-NS-treated attacks in 55.0% of patients in Study 1 and 52.1% of patients in Study 2. 24hSPF was reported in at least two of the first three S-NS-treated attacks in 35.7% of patients in Study 1 and 32.6% of patients in Study 2. The incidences of any adverse event and of specific adverse events were low and generally similar between S-NS and placebo.