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Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis.
J Fam Pract. 2002 Jun; 51(6):530-7.JF

Abstract

OBJECTIVE

We compared the efficacy and upper gastrointestinal safety of the cyclooxygenase-2-specific inhibitor valdecoxib with naproxen and placebo in treating moderate to severe osteoarthritis of the knee.

STUDY DESIGN

This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and upper gastrointestinal tract safety of valdecoxib at dosages of 5, 10, and 20 mg once daily with placebo and naproxen at the dosage of 500 mg twice daily.

POPULATION

We included patients who had been diagnosed with moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology.

OUTCOMES MEASURED

The Patient's and Physician's Global Assessment of Arthritis (PaGAA, PhGAA), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), and Western Ontario and McMaster's Universities (WOMAC) Osteoarthritis indices were assessed at baseline and at weeks 2, 6, and 12. Upper gastrointestinal ulceration was assessed by pre- and posttreatment endoscopies.

RESULTS

Valdecoxib 10 and 20 mg once daily (but not 5 mg once daily) demonstrated similar efficacy to naproxen at 500 mg twice daily, and all 3 dosages were superior to placebo for the PaGAA, PhGAA, PAAP-VAS, and WOMAC Osteoarthritis indices at most assessments throughout the 12-week study (P <.05). The incidence of endoscopically proven ulcers was significantly higher in the naproxen group than in the 5- and 10-mg valdecoxib groups, but not in the 20-mg valdecoxib group. All 3 valdecoxib doses were comparable to placebo in ulcer incidence.

CONCLUSIONS

Valdecoxib (10 and 20 mg once daily) is significantly superior to placebo and as effective as naproxen (500 mg twice daily) in improving moderate to severe osteoarthritis of the knee. Upper gastrointestinal tract safety of valdecoxib (5 and 10 mg) was comparable to that of placebo and significantly better than that of naproxen.

Authors+Show Affiliations

Altoona Center for Clinical Research, Duncansville, PA, USA.No affiliation info availableNo 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

12100776

Citation

Kivitz, Alan, et al. "Randomized Placebo-controlled Trial Comparing Efficacy and Safety of Valdecoxib With Naproxen in Patients With Osteoarthritis." The Journal of Family Practice, vol. 51, no. 6, 2002, pp. 530-7.
Kivitz A, Eisen G, Zhao WW, et al. Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis. J Fam Pract. 2002;51(6):530-7.
Kivitz, A., Eisen, G., Zhao, W. W., Bevirt, T., & Recker, D. P. (2002). Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis. The Journal of Family Practice, 51(6), 530-7.
Kivitz A, et al. Randomized Placebo-controlled Trial Comparing Efficacy and Safety of Valdecoxib With Naproxen in Patients With Osteoarthritis. J Fam Pract. 2002;51(6):530-7. PubMed PMID: 12100776.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis. AU - Kivitz,Alan, AU - Eisen,Glenn, AU - Zhao,William W, AU - Bevirt,Terry, AU - Recker,David P, PY - 2002/7/9/pubmed PY - 2002/8/17/medline PY - 2002/7/9/entrez SP - 530 EP - 7 JF - The Journal of family practice JO - J Fam Pract VL - 51 IS - 6 N2 - OBJECTIVE: We compared the efficacy and upper gastrointestinal safety of the cyclooxygenase-2-specific inhibitor valdecoxib with naproxen and placebo in treating moderate to severe osteoarthritis of the knee. STUDY DESIGN: This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and upper gastrointestinal tract safety of valdecoxib at dosages of 5, 10, and 20 mg once daily with placebo and naproxen at the dosage of 500 mg twice daily. POPULATION: We included patients who had been diagnosed with moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology. OUTCOMES MEASURED: The Patient's and Physician's Global Assessment of Arthritis (PaGAA, PhGAA), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), and Western Ontario and McMaster's Universities (WOMAC) Osteoarthritis indices were assessed at baseline and at weeks 2, 6, and 12. Upper gastrointestinal ulceration was assessed by pre- and posttreatment endoscopies. RESULTS: Valdecoxib 10 and 20 mg once daily (but not 5 mg once daily) demonstrated similar efficacy to naproxen at 500 mg twice daily, and all 3 dosages were superior to placebo for the PaGAA, PhGAA, PAAP-VAS, and WOMAC Osteoarthritis indices at most assessments throughout the 12-week study (P <.05). The incidence of endoscopically proven ulcers was significantly higher in the naproxen group than in the 5- and 10-mg valdecoxib groups, but not in the 20-mg valdecoxib group. All 3 valdecoxib doses were comparable to placebo in ulcer incidence. CONCLUSIONS: Valdecoxib (10 and 20 mg once daily) is significantly superior to placebo and as effective as naproxen (500 mg twice daily) in improving moderate to severe osteoarthritis of the knee. Upper gastrointestinal tract safety of valdecoxib (5 and 10 mg) was comparable to that of placebo and significantly better than that of naproxen. SN - 0094-3509 UR - https://www.unboundmedicine.com/medline/citation/12100776/Randomized_placebo_controlled_trial_comparing_efficacy_and_safety_of_valdecoxib_with_naproxen_in_patients_with_osteoarthritis_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=12100776.ui DB - PRIME DP - Unbound Medicine ER -