Efficacy and safety of the COX-2 specific inhibitor valdecoxib in the management of osteoarthritis of the hip: a randomized, double-blind, placebo-controlled comparison with naproxen.
OBJECTIVE
Non-steroidal antiinflammatory agents are commonly used to treat pain and inflammation associated with osteoarthritis (OA), but have poor gastrointestinal (GI) tolerability. This study compared the efficacy of the COX-2 specific inhibitor valdecoxib with naproxen and placebo, in treating symptomatic OA of the hip.


METHODS
This multicenter, randomized, double-blind 12-week study compared the efficacy and tolerability of single daily doses of valdecoxib 5 mg and 10 mg with placebo or naproxen 500 mg BID. Efficacy was assessed by Patient's and Physician's Global Assessment of Arthritis, and the WOMAC (Western Ontario and McMasters) OA Individual and Composite Indices. The incidence of adverse events was monitored throughout the study.


RESULTS
Valdecoxib was clinically and statistically superior to placebo for Patient's and Physician's Global Assessment of Arthritis and for all WOMAC OA Indices over the 12 week study period (P<or= 0.05). Valdecoxib 10 mg was similar to naproxen in terms of efficacy, and demonstrated greater numerical improvements compared with valdecoxib 5 mg. Valdecoxib 5 mg and 10 mg demonstrated similar tolerability compared to placebo and a lower incidence of GI-related adverse effects compared with naproxen.


CONCLUSIONS
Single daily doses of valdecoxib 5 mg and 10 mg were similar to naproxen and superior to placebo, in treating symptomatic OA of the hip. Both doses of valdecoxib were well tolerated and demonstrated improved GI tolerability compared to naproxen.
Makarowski
W
W
Rheumatology Associates of NW Pennsylvania, Erie, Pennsylvania, USA.
Zhao
William W
WW
Bevirt
Terry
T
Recker
David P
DP
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use; D016009:Chi-Square Distribution; D003248:Constipation / Q000139:chemically induced; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004415:Dyspepsia / Q000139:chemically induced; D006801:Humans; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008565:Membrane Proteins; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects / Q000627:therapeutic use; D015207:Osteoarthritis, Hip / Q000188:drug therapy*; D011451:Prostaglandin-Endoperoxide Synthases; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000096926:Benzenesulfonamides
D000894:Anti-Inflammatory Agents, Non-Steroidal; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D007555:Isoxazoles; D008565:Membrane Proteins; D009288:Naproxen; D011451:Prostaglandin-Endoperoxide Synthases; D013449:Sulfonamides; C406224:valdecoxib; D000096926:Benzenesulfonamides; C496540:PTGS2 protein, human