Valdecoxib Is Associated with Improved Dyspepsia-Related Health Compared with Nonspecific NSAIDs in Patients with Osteoarthritis or Rheumatoid Arthritis

Rabeneck, Linda; Goldstein, Jay L.; Vu, An; Mayne, Tracy J.; Rublee, Dale A.
May 2005
American Journal of Gastroenterology;May2005, Vol. 100 Issue 5, p1043
Academic Journal
OBJECTIVES: Dyspepsia and related gastrointestinal (GI) symptoms are commonly reported by patients taking nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs) and significantly impact treatment effectiveness, cost, and quality of life. This study sought to evaluate dyspepsia-related health in osteoarthritis (OA) and rheumatoid arthritis (RA) patients taking valdecoxib compared with patients taking nonspecific NSAIDs.METHODS: Analysis of two separate, double-blind, placebo-controlled studies: one in RA patients randomized to placebo, valdecoxib (10 and 20 mg once daily[o.d.]) and naproxen (500 mg twice daily[b.i.d.]); one in OA patients randomized to placebo, valdecoxib (10 and 20 mg o.d.), diclofenac (75 mg b.i.d.), or ibuprofen (800 mg three times daily[t.i.d.]). Study population comprised patients with RA in flare or clinically documented OA who required chronic symptomatic treatment with NSAIDs/analgesics. Dyspepsia-related health was evaluated at baseline and weeks 2, 6, and 12 (or early termination) using the validated Severity of Dyspepsia Assessment (SODA) questionnaire. This patient self-report tool consists of scales for evaluating dyspepsia pain intensity, nonpain symptoms, and satisfaction. Analysis was based on the intent-to-treat population with the last observation carried forward.RESULTS: Valdecoxib was significantly better at endpoint than standard doses of naproxen, diclofenac, and ibuprofen for pain intensity scores (p<0.05), and provided significantly improved nonpain symptom and satisfaction scores compared with naproxen for patients with RA (p<0.05). For RA patients, the difference between valdecoxib and naproxen pain intensity scores were clinically meaningful; at all the time points, significantly fewer patients receiving valdecoxib reported severe dyspepsia pain intensity increases (≥10 points) than those receiving naproxen. At 12 wk, fewer patients receiving valdecoxib reported severe dyspepsia pain intensity increasesversusthose receiving ibuprofen and diclofenac.CONCLUSIONS: The GI tolerability of valdecoxib is superior to that of nonspecific NSAIDs, and therefore can potentially have a favorable impact on patient quality of life.(Am J Gastroenterol 2005;100:1043–1050)


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