TY - JOUR
T1 - Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis
T2 - Results of two similarly designed studies
AU - Smugar, Steven S.
AU - Schnitzer, Thomas J.
AU - Weaver, Arthur L.
AU - Rubin, Bernard R.
AU - Polis, Adam B.
AU - Tershakovec, Andrew M.
N1 - Funding Information:
by Merck and Company, Inc. Drs. Smugar and Tershakovec and Mr. Polis are employees of Merck & Co., Inc. Dr. Schnitzer has served as a consultant to GlaxoSmithKline, Merck & Co., Inc., NicOx, Novartis, and Winston Laboratories, has received clinical research support from Endo Pharmaceuticals, Merck & Co., Inc., Novartis, Pfizer, and Winston Laboratories, and has equity interest in NicOx SA. Dr. Weaver has financial interest/relationship or affiliation with one or more organizations including consultant status, medical advisory boards, and speakers’ bureaus. These companies include Abbott, Amgen, Astellas, Aventis, Biovail, Boehringer-Ingelheim, Bristol-Myers Squibb, Centocor, Cypress Bioscience, Fugisawa, Genentech, Helsinn, Immunex, Lilly, Medecisive Laboratories, Merck & Co., Inc. Merckel, Novartis, Ortho-McNeil, Parke-Davis, Pfizer, Pharmacia, Primus Pharmaceuticals, Prometheus, Schwarz Biosciences, TAP, Takeda, Theraquest, and Wyeth. Dr. Weaver is also on the board of directors of MGI Pharma. Dr Rubin has received research grants from Merck, Pfizer, Genentech, Centocor, Novartis, TAP. He is on the Speaker’s Bureau or as served as a consultant to Merck, Pfizer, Amgen, Wyeth, Abbott, Genentech, Lilly.
PY - 2006/7
Y1 - 2006/7
N2 - 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.
AB - 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.
KW - Celecoxib
KW - Night pain
KW - Osteoarthritis
KW - PGART
KW - Rofecoxib
KW - WOMAC
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UR - http://www.scopus.com/inward/citedby.url?scp=33746136948&partnerID=8YFLogxK
U2 - 10.1185/030079906X104876
DO - 10.1185/030079906X104876
M3 - Article
C2 - 16834834
AN - SCOPUS:33746136948
SN - 0300-7995
VL - 22
SP - 1353
EP - 1367
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 7
ER -