Source: Genomics  |  Posted 10 years ago

By Jill Stein
Special to DG News

BALTIMORE, MD -- March 18, 2002 -- The highly selective COX-2 inhibitor etoricoxib is as effective as naproxen sodium when used to treat primary dysmenorrhea.

Dr. Kerstin Malmstrom, with Merck Research Laboratories, in Rahway, New Jersey, described the results of this study at the 21st Annual Scientific meeting of the American Pain Society (APS).

Seventy-three women with primary dysmenorrhea were randomized to receive single doses of etoricoxib, 120 mg, naproxen sodium, 550 mg, or placebo in a double- blind, three- period crossover study. Trial participants were 18 years of age or older with a self-reported history of moderate to severe primary dysmenorrhea who had required treatment with analgesics during at least four of the last six menstrual cycles.

During the 24- hour time period after dosing in each period, patients reported pain relief and pain intensity scores and a global evaluation of their assigned medication. Sixty seven women completed all three periods and 67 women received each treatment.

The primary efficacy endpoint was total pain relief over eight hours (TOPAR8).

Patients treated with etoricoxib experienced faster, greater, and longer pain relief than patients treated with placebo. Etoricoxib, 120 mg, had similar analgesic effects as naproxen, 550 mg, including overall effect, time to onset, and peak and duration of effect. Significantly fewer patients required rescue analgesia within 24 hours of taking the study drug in the etoricoxib group (13.4 percent) and naproxen group (19.4 percent) compared with placebo (44 percent). Etoricoxib was generally well tolerated.

Primary dysmenorrhea is the most common gynecological disorder in menstruating women. The condition presents primarily as cramping pain in the lower abdomen before or during menstruation.

The authors of this study are from Merck Research Laboratories in Rahway, N.J. and Scirex Cooperation in Austin, Texas.