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

Abstract

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. 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. 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 increases versus those receiving ibuprofen and diclofenac. 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.