The American Academy of Pain Medicine      Annual Meeting Home Page     
24th Annual Meeting
February 13-16, 2008
Orlando, FL
© 2006 American Academy of Pain Medicine
 


Thursday, February 14, 2008
194

Effects of 12-Hour, Extended-Release Hydrocodone/Acetaminophen on Pain-Related Physical Function, Work Productivity, and Sleep Quality: A 56-Week, Open-Label Study

Dave Webster, DO1, Darrell Herrington, DO2, Bruce C. Corser, MD3, Ronald Rapoport, MD4, Ara Hagop Dikranian, MD5, James W. Thomas, MS6, Pamela G. Vo, PharmD, MS6, Andrea Best, DO6, Steven E. Marx, PharmD, MS6, and Rita Jain, MD6. (1) Team Research of Central Texas, Killeen, TX, USA, (2) Benchmark Research, San Angelo, TX, USA, (3) Community Research, Cincinnati, OH, USA, (4) Truesdale Clinic, Fall River, MA, USA, (5) San Diego Arthritis Medical Clinic, San Diego, CA, USA, (6) Abbott Laboratories, Abbott Park, IL, USA

Introduction

Osteoarthritis (OA) and mechanical chronic low back pain (CLBP) are common pain conditions that can have significant negative impact on physical function, work productivity, and sleep quality. Pain reduction is the primary treatment goal, however, improvements in sleep, productivity, and/or maintaining physical functioning are also important. The primary objective was to assess long-term safety and efficacy of extended-release hydrocodone/acetaminophen (HC/APAP CR). Here, we report results from secondary objectives: sleep, physical function/role, and productivity.

Methods

Detailed information on the primary endpoint and study design has been reported. Secondary endpoints were assessed using Brief Pain Inventory (BPI), Work Productivity and Activity Impairment (WPAI), and SF-36 questionnaires that occurred at baseline, weeks 24 and 56. BPI was also administered at weeks 4, 12, and 40.

Results

Patients showed improvement in all BPI pain assessments from baseline to each evaluation periods. Particularly, for the pain-related interference group, patients had less sleep interference (decreased~40-50%) and less interference in walking ability due to pain (decreased~30-40%) from baseline to weeks 4, 12, 24, 40 and 56.

At week 24, impairment while working due to health decreased from baseline 17.4%, and impairment of regular daily activities decreased 24.7%. At week 56, impairment while working due to health decreased from baseline 16.6%, and impairment of regular daily activities decreased 22.3%. Overall impairment due to health decreased 17.5% at week 24 and 15.8% at week 56.

Improvements in all 8-domains of the SF-36 were observed from baseline to study endpoints. Bodily pain, physical role, and physical functioning domains showed the greatest improvements (mean change: 18.13, 17.46, 14.40, respectively) among the 8-domains at week 24. At final visit, these domains continued to show greatest improvement.

Conclusion

In this study, OA and CLBP patients taking HC/APAP CR demonstrated improvement in physical function/role and less productivity impairment and pain-related sleep interference.


References: Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003 Nov 12;290(18):2443-54.
Funding: Funded by Abbott Laboratories Inc., Abbott Park, IL

Dave Webster, DO
Conflict of Interest Disclosure: Abbott Laboratories Inc., Researcher

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