Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis: results of two similarly designed studies.

Abstract

OBJECTIVE:

To compare the efficacy of rofecoxib and celecoxib for the treatment of knee or hip OA over 6 weeks.

METHODS:

Two similarly designed, multicenter, randomized, double-blind, placebo-controlled studies. Patients were randomly assigned 3:3:3:1 in Study 1 to once daily (QD) rofecoxib 12.5 mg (N = 456), rofecoxib 25 mg (N = 459), celecoxib 200 mg (N = 456), or placebo (N = 150) and 3:3:1 in Study 2 to QD rofecoxib 25 mg (N = 471), celecoxib 200 mg (N = 460), or placebo (N = 151). There was no rofecoxib 12.5 mg arm in Study 2. The primary outcome measure of both studies was pain at night over 6 weeks for rofecoxib 25 mg vs. celecoxib 200 mg. Efficacy comparisons with rofecoxib 12.5 mg in Study 1 were included as pre-specified study objectives but not as pre-specified study hypotheses. Secondary endpoints included Patient Global Assessment of Response to Therapy (PGART) over 6 weeks and over 1 week. Safety was evaluated through the assessment of spontaneously reported adverse experiences (AEs), evaluation of vital signs, and laboratory data reported by investigators and patients.

RESULTS:

For the primary endpoint, reduction in pain at night over 6 weeks in Study 1 was not significantly different between active treatments; in Study 2 rofecoxib 25 mg significantly (p = 0.023) reduced pain at night compared with celecoxib 200 mg over 6 weeks. For the secondary endpoints, in both studies, significantly (p < 0.05) more patients treated with rofecoxib 25 mg than celecoxib 200 mg had a good or excellent PGART over 6 weeks, and over the first week (p < 0.01). In both studies, there were no significant differences between active medications in the incidence of reported overall, serious, or drug-related AEs. The reported AE rates with the active treatments were generally similar to those with placebo in the two studies.

CONCLUSIONS:

Rofecoxib 25 mg was significantly better than celecoxib 200 mg in relieving night pain at 6 weeks in one study; this was not confirmed in the accompanying study.

• Authors: Steven S Smugar, Thomas J Schnitzer, Arthur L Weaver, Bernard R Rubin, Adam B Polis, Andrew M Tershakovec
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 22 Issue 7 Pg. 1353-67 (Jul 2006) ISSN: 0300-7995 [Print] England
• PMID: 16834834 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Lactones
• Pyrazoles
• Sulfonamides
• Sulfones
• rofecoxib
• Celecoxib

Topics

• Adult
• Aged
• Aged, 80 and over
• Celecoxib
• Double-Blind Method
• Female
• Humans
• Lactones (administration & dosage)
• Male
• Middle Aged
• Osteoarthritis (drug therapy)
• Osteoarthritis, Hip (drug therapy)
• Osteoarthritis, Knee (drug therapy)
• Pyrazoles (administration & dosage)
• Sulfonamides (administration & dosage)
• Sulfones (administration & dosage)
• Treatment Outcome