Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis.
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.


METHODS
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.


METHODS
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.


METHODS
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.
Kivitz
Alan
A
Altoona Center for Clinical Research, Duncansville, PA, USA.
Eisen
Glenn
G
Zhao
William W
WW
Bevirt
Terry
T
Recker
David P
DP
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004064:Digestive System / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D010003:Osteoarthritis / Q000188:drug therapy*; D010147:Pain Measurement; D013449:Sulfonamides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007555:Isoxazoles; D009288:Naproxen; D013449:Sulfonamides; C406224:valdecoxib; D000096926:Benzenesulfonamides