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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

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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™). 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™ 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).

Conclusion: 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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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgments

This study was funded by Janssen Pharmaceutica and Ortho-McNeil Janssen Scientific Affairs, LLC.

Kavita Gajria was an employee of QualityMetric Incorporated at the time of writing this article and was a paid consultant for Janssen Pharmaceutica and Ortho-McNeil Janssen Scientific Affairs, LLC. Mark Kosinski is an employee of QualityMetric Incorporated and is a paid consultant for Ortho-McNeil Janssen Scientific Affairs, LLC (Raritan, NJ, USA) and Janssen Pharmaceutica (Beerse, Belgium). Jeff Schein is an employee of and owns stock in Ortho-McNeil Janssen Scientific Affairs, LLC (Raritan, NJ, USA). Shane Kavanagh is an employee of Janssen Pharmaceutica (Beerse, Belgium) and owns stock in Johnson & Johnson. Dominique Dubois was an employee of Janssen Pharmaceutica (Beerse, Belgium) at the time of writing of this article and owns stock in Johnson & Johnson.

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Authors and Affiliations

  1. Abt Bio-Pharma Solutions, Incorporated, 181 Spring Street, Lexington, Massachusetts, 02421, USA

    Kavita Gajria

  2. QualityMetric Incorporated, Lincoln, Rhode Island, USA

    Mark Kosinski

  3. Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA

    Jeff Schein

  4. Janssen Pharmaceutica, Beerse, Belgium

    Shane Kavanagh

  5. Patient Value Solutions, Huldenberg, Belgium

    Dominique Dubois

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  1. Kavita Gajria
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Correspondence to Kavita Gajria.

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Gajria, K., Kosinski, M., Schein, J. et al. 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. Patient-Patient-Centered-Outcome-Res 1, 223–238 (2008). https://doi.org/10.2165/1312067-200801030-00009

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