Abstract
Chronic osteoarthritis (OA) pain impacts health-related quality of life (HR-QOL). The primary aim of this study was to evaluate and compare HR-QOL outcomes following treatment with once-daily push-pull Osmotic controlled-Release Oral delivery System (OROS) hydromorphone versus twice-daily extended-release (ER) oxycodone for moderate to severe chronic knee or hip OA pain. This was a 6-week, randomized, open-label, parallel-group, multicenter study of 124patients with OA whose pre-trial treatment included NSAIDs or other non-steroidal, non-opioid analgesics. The HR-QOL of patients was assessed using the Medical Outcomes Study (MOS) Sleep Scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™). Within- and between-group changes from baseline to 6weeks were evaluated using ANOVA. At baseline, trial patients had significantly worse MOS Sleep Scale (multivariate ANOVA [MANOVA] F = 11.0, p < 0.001) and WOMAC™ scores (MANOVA F = 55.7, p < 0.001) than chronic disease benchmarks. Both treatment groups showed significant improvements on the sleep disturbance scale (p < 0.01), with additional improvements observed with OROS hydromorphone on the sleep quantity (p = 0.046), sleep snoring (p = 0.044), awaken short of breath or with a headache (p = 0.024), 6-item sleep problems index I (p < 0.001), and 9-item sleep problems index II (p < 0.001) scales. Significant treatment differences in favor of OROS hydromorphone over ER oxycodone were also observed on the awaken short of breath or with a headache (p = 0.014) scale and sleep problems index I (p = 0.045). Both treatment groups showed comparable large effect size (>0.8 SD unit) improvements on the WOMAC™ scale (measuring functionality outcomes such as pain, stiffness, physical function etc). Both OROS hydromorphone and ER oxycodone improved sleep and function, with greater sleep benefits being observed in patients treated with OROS hydromorphone.
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