Health-Related Quality-of-Life Outcomes in Patients Treated with Push-Pull OROS Hydromorphone versus Extended-Release Oxycodone for Chronic Hip or Knee Osteoarthritis Pain: A Randomized, Open-Label, Parallel-Group, Multicenter Study
Kavita Gajria (Abt Bio-Pharma Solutions, Incorporated, Lexington, Massachusetts, USA) Mark Kosinski (QualityMetric Incorporated, Lincoln, Rhode Island, USA) Jeff Schein (Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA) Shane Kavanagh (Janssen Pharmaceutica, Beerse, Belgium) Dominique Dubois (Patient Value Solutions, Huldenberg, Belgium)
Abstract
Background: Chronic osteoarthritis (OA) pain impacts health-related quality of life (HR-QOL). Objective: 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. Methods: This was a 6-week, randomized, open-label, parallel-group, multicenter study of 124 patients 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(TM)). Within- and between-group changes from baseline to 6 weeks were evaluated using ANOVA. Results: At baseline, trial patients had significantly worse MOS Sleep Scale (multivariate ANOVA [MANOVA] F_=_11.0, p_<_0.001) and WOMAC(TM) 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(TM) scale (measuring functionality outcomes such as pain, stiffness, physical function etc). Conclusion: Both OROS hydromorphone and ER oxycodone improved sleep and function, with greater sleep benefits being observed in patients treated with OROS hydromorphone. DOI: 10.2165/1312067-200801030-00009
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