A comparison of valdecoxib (Bextra) & naproxen in the treatment of arthritis symptoms

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A comparison of valdecoxib and naproxen in the treatment of rheumatoid

arthritis symptoms.

Clin Ther. 2006 Feb;28(2):204-21.

GW, Kivitz AJ, Brown MT, Verburg KM.

Department of Medicine, Scripps Clinic, La Jolla, California 92037, USA.

GWWMDPHD@...

OBJECTIVES: The primary aim of this work was to compare the efficacy of

valdecoxib 10, 20, and 40 mg QD with that of placebo and naproxen 500 mg BID

in patients with rheumatoid arthritis (RA). The overall safety and

tolerability profiles of valdecoxib and naproxen were also compared.

METHODS: A 12-week, multicenter, randomized, double-blind, parallel-group,

placebo- and active-controlled study was performed in patients with

adult-onset RA whose disease was in a flare state after discontinuing NSAIDs

or other analgesics. Patients were randomly assigned to valdecoxib 10, 20,

or 40 mg QD, naproxen 500 mg BID, or placebo. The primary efficacy measures

were the American College of Rheumatology (ACR) 20% responder index

(ACR-20), physicians' assessments of tender/painful joint count and swollen

joint count, and patients' and physicians' global assessments of disease

activity. Adverse events, clinical laboratory data, and vital signs were

assessed by the investigator and compared between treatment groups to

evaluate overall tolerability and safety.

RESULTS: A total of 1093 patients were randomized to receive either

valdecoxib 10 mg QD (n=226), valdecoxib 20 mg QD (n=219), valdecoxib 40 mg

QD (n=209), naproxen 500 mg BID (n=219), or placebo (n=220). At all time

points, the proportion of ACR-20 responders was significantly higher in the

valdecoxib groups than the placebo group at weeks, 6, and 12. Similarly, at

all time points, the proportion of ACR-20 responders was significantly

higher in the naproxen 500-mg group than the placebo group.

In addition, mean changes in the number of tender/painful joint counts were

significantly greater in the valdecoxib groups than the placebo group at

weeks 2, 6, and 12. Naproxen treatment was also associated with greater

reductions in tender/painful joint count than placebo.

Mean changes in swollen joint count decreased at all time points in all

groups, with significantly greater changes in the valdecoxib and naproxen

treatment groups than the placebo group. Physicians' global assessments of

disease activity scores were significantly lower in the valdecoxib and

naproxen treatment groups than the placebo group.

Adverse events were reported by 45.5% patients in the placebo group, 51.8%

in the valdecoxib 10 mg QD group, 58.0% in the valdecoxib 20 mg QD group,

56.9% in the valdecoxib 40 mg QD group, and 62.6% in the naproxen 500 mg BID

treatment group.

CONCLUSIONS: Valdecoxib 10, 20, and 40 mg QD were efficacious for treating

the signs and symptoms of RA in these patients. The efficacy of valdecoxib

20 and 40 mg QD was not significantly different from that of naproxen 500 mg

BID. Valdecoxib was generally well tolerated in this study.

PMID: 16678642 [PubMed - in process]