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Ric Day, MD; Briggs Morrison, MD; Armando Luza, MD; Oswaldo Castaneda, MD; Alberto Strusberg, MD; Menachem Nahir, MD; Knut Bjorn Helgetveit, MD; Barbara Kress, RN; Brian Daniels, MD; James Bolognese; Dave Krupa; Beth Seidenberg, MD; Elliot Ehrich, MD; for the Rofecoxib/Ibuprofen Comparator Study Group

Arch Intern Med. 2000;160:1781-1787.

Background  Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). It is not known whether a specific inhibitor of COX-2 will provide efficacy in osteoarthritis (OA) comparable with NSAIDs. Therefore, we compared the efficacy and safety of the rofecoxib, which specifically inhibits COX-2, with those of the NSAID ibuprofen in patients with OA.

Objective  To compare the clinical efficacy and tolerability of rofecoxib (12.5 and 25 mg once daily) with ibuprofen (800 mg 3 times daily).

Methods  A randomized, double-blind trial of 809 adults with OA was conducted. Patients with OA in whom the knee or hip was the primary source of pain were randomized to 1 of 4 treatment groups on demonstration of disease activity: placebo; rofecoxib, 12.5 or 25 mg once daily; or ibuprofen, 800 mg 3 times daily. Clinical efficacy and safety were monitored during a 6-week treatment period.

Results  Both doses of rofecoxib demonstrated efficacy clinically comparable with ibuprofen as assessed by 3 primary end points (pain walking on a flat surface [Western Ontario and McMaster Universities Osteoarthritis Index], patient global assessment of response to therapy, and investigator global assessment of disease status) according to predefined comparability criteria. Both rofecoxib doses and the ibuprofen dose provided significantly (P<.001) greater efficacy than placebo on all primary end points. Results from secondary end points were consistent with those of the primary end points. All treatments were well tolerated; the overall incidence rates of clinical adverse experiences were not significantly different (P>.05) among the treatment groups.

Conclusion  Rofecoxib was well tolerated and provided clinical efficacy comparable with a high dose of the NSAID ibuprofen.

From St Vincent's Hospital, Darlinghurst, Australia (Dr Day); Merck Research Laboratories, Rahway, NJ (Drs Morrison, Daniels, Seidenberg, and Ehrich, Ms Kress, and Mssrs Bolognese and Krupa); Clinica San Pablo, Surca Lima, Peru (Dr Luza); Clinica Anglo-Americana, Lima, Peru (Dr Castaneda); Department of Rheumatology, Rambam Medical Center, Haifa, Israel (Dr Nahir); and Martina Hansens Hospital, Baerum, Norway (Dr Helgetveit). Dr Strusberg is in private practice in Cordoba, Argentina.

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