Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study.
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.
Lipton
R B
RB
Albert Einstein College of Medicine and the Montefiore Headache Center, Bronx, New York, NY 10461, USA. rlipton@aecomy.yu.edu
Dodick
D W
DW
Adelman
J U
JU
Kaniecki
R G
RG
Lener
S E
SE
White
J D
JD
Nelsen
A C
AC
D000293:Adolescent; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D009288:Naproxen / Q000008:administration & dosage*; D010147:Pain Measurement / Q000187:drug effects* / Q000706:statistics & numerical data; D015990:Placebo Effect; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage; D018170:Sumatriptan / Q000008:administration & dosage*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D016861:Cyclooxygenase Inhibitors; D017366:Serotonin Receptor Agonists; D009288:Naproxen; D018170:Sumatriptan