BALTIMORE, MD — March 15, 2002 — The new cyclooxigenase (COX)-2 selective inhibitor etoricoxib may prove to be a useful tool in the management of patients with chronic low back pain, suggest results reported here today at the 21st Annual Scientific Meeting of the American Pain Society (APS).
Dr. Gregory P. Geba, with Merck & Co., in West Point, Pennsylvania, described the results of a study in which 319 patients with chronic low back pain were randomized to 12 weeks' treatment with etoricoxib 60 mg or 90 mg QD, or placebo. Acetaminophen was permitted as rescue therapy in doses that did not exceed 1,950 mg/day.
All participants in the trial had low back pain that was present for at least three months, which they treated with either a non-steroidal anti-inflammatory drug (NSAID) or acetaminophen on a regular basis. Subjects were also NSAID/acetaminophen- responsive and had demonstrated a flare-up of low back pain upon withdrawal from prior therapy.
The primary efficacy measure was time-weighted average response (change from baseline or treatment value) over four weeks and over 12 weeks of treatment.
Both doses of etoricoxib provided significant pain relief and improvement in disability scores at the primary time point of four weeks. Treatment differences from placebo appeared to be established as early as one week after the start of therapy.
Etoricoxib was generally safe and well tolerated.
After four weeks of treatment, the mean change from baseline in Low Back Pain Intensity Scale (LBP) score was -36.13 for the 60 mg group, -33.48 for the 90 mg group, and -23.19 for the placebo group (p<0.005). On the Roland and Morris Disability Questionnaire (R/M), the mean change was -6.19 with 60 mg, -6.05 with 90 mg, and -3.75 with placebo (p<0.005).
After 12 weeks of treatment, mean change in LBP was -37.38 with etoricoxib 60 mg (p<0.005), -34.42 with the 90 mg dosage (p<0.05), and -26.92 with placebo. The mean change in R/M disability score was -6.75 with 60 mg of etoricoxib, -6.38 with 90 mg, and -4.32 with placebo (p<0.005).