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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.
Osteoarthritis Cartilage. 2002 Apr; 10(4):290-6.OC

Abstract

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.

DESIGN

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.

Authors+Show Affiliations

Rheumatology Associates of NW Pennsylvania, Erie, Pennsylvania, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11950252

Citation

Makarowski, W, et al. "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." Osteoarthritis and Cartilage, vol. 10, no. 4, 2002, pp. 290-6.
Makarowski W, Zhao WW, Bevirt T, et al. 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. Osteoarthritis Cartilage. 2002;10(4):290-6.
Makarowski, W., Zhao, W. W., Bevirt, T., & Recker, D. P. (2002). 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. Osteoarthritis and Cartilage, 10(4), 290-6.
Makarowski W, et al. 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. Osteoarthritis Cartilage. 2002;10(4):290-6. PubMed PMID: 11950252.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Makarowski,W, AU - Zhao,William W, AU - Bevirt,Terry, AU - Recker,David P, PY - 2002/4/13/pubmed PY - 2002/5/15/medline PY - 2002/4/13/entrez SP - 290 EP - 6 JF - Osteoarthritis and cartilage JO - Osteoarthritis Cartilage VL - 10 IS - 4 N2 - 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. DESIGN: 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. SN - 1063-4584 UR - https://www.unboundmedicine.com/medline/citation/11950252/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1063458401905102 DB - PRIME DP - Unbound Medicine ER -