Abstract

Health-related quality-of-life (HRQoL) measures provide important information about the outcomes of treatment from the patient’s perspective. In this study, HRQoL outcomes of opioid therapy for the treatment of chronic osteoarthritis (OA) pain were evaluated. A 6-week, open-label, randomized, comparative, repeated-dose, parallel-group study assessed the efficacy, safety, and quality-of-life impact of once-daily OROS® hydromorphone and twice-daily ER oxycodone in 126 patients with chronic OA pain of the knee or hip who had received chronic NSAIDs or another non-steroidal, non-opioid analgesic. Patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at baseline and after 6 weeks of treatment. HRQoL outcomes were defined as changes in WOMAC scale scores from baseline to 6 weeks and were evaluated within and between treatment groups using analysis of variance. Large effect size (>0.8 SD unit) improvements in WOMAC scale scores were observed in both treatment groups. Among OROS® hydromorphone patients, mean (SE) scores improved by 12.6 (±1.6, P< .001) points on the WOMAC physical function scale, 4.3 (±0.5, P< .001) points on the WOMAC pain scale, and 1.7 (±0.2, P< .001) points on the WOMAC stiffness scale. For patients receiving ER oxycodone, scores improved by 11.8 (±1.8, P< .001) points on the WOMAC physical function scale, 4.0 (±0.5, P< .001) points on the WOMAC pain scale, and 1.8 (±0.3, P< .001) points on the WOMAC stiffness scale. Differences in outcomes between treatment groups were not statistically significant. OROS® hydromorphone provides an effective once-daily treatment option for patients with chronic OA pain as evidenced by the significant HRQoL improvement (relative to baseline) in WOMAC physical function, pain, and stiffness scale scores.

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