A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster

Dworkin, Robert H.; Barbano, Richard L.; Tyring, Stephen K.; Betts, Robert F.; McDermott, Michael P.; Pennella-Vaughan, Janet; Bennett, Gary J.; Berber, Erhan; Gnann, John W.; Irvine, Carrie; Kamp, Cornelia; Kieburtz, Karl; Max, Mitchell B.; Schmader, Kenneth E.

doi:10.1016/j.pain.2008.12.022

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Volume 142, Issue 3 , Pages 209-217, April 2009

A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster

Robert H. Dworkin
- Departments of Anesthesiology and Neurology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 604, Rochester, NY 14642, USA
- Corresponding author. Tel.: +1 585 275 3524; fax: +1 585 473 5007.
Richard L. Barbano
- Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Stephen K. Tyring
- Department of Dermatology, University of Texas Health Science Center and the Center for Clinical Studies, Houston, TX, USA
Robert F. Betts
- Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Michael P. McDermott
- Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Janet Pennella-Vaughan
- Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Gary J. Bennett
- Department of Anesthesiology, McGill University, Montreal, Canada
Erhan Berber
- Novartis Pharmaceuticals, East Hanover, NJ, USA
John W. Gnann
- Departments of Medicine, Pediatrics, and Microbiology, University of Alabama at Birmingham and Birmingham Veterans Administration Medicine Center, Birmingham, AL, USA
Carrie Irvine
- Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Cornelia Kamp
- Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Karl Kieburtz
- Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Mitchell B. Max
- Department of Anesthesiology, University of Pittsburgh, Pittsburgh, PA, USA
Kenneth E. Schmader
- Department of Medicine-Geriatrics, Duke University, and GRECC, Durham VA Medical Center, Durham, NC, USA

Received 3 September 2008; received in revised form 10 November 2008; accepted 15 December 2008. published online 05 February 2009.

Abstract

Although acute pain in patients with herpes zoster can be severe and has a substantial impact on health-related quality of life, there have been no randomized clinical trials of oral medications specifically for its ongoing treatment. A randomized clinical trial was conducted in which 87 subjects ⩾50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24h⩾3 on a 0–10 rating scale initiated 7 days of treatment with famciclovir in combination with 28 days of treatment with either controlled-release (CR) oxycodone, gabapentin, or placebo. Subjects were evaluated for adverse effects of treatment, acute pain, and health-related quality of life. The results showed that CR-oxycodone and gabapentin were generally safe and were associated with adverse events that reflect well-known effects of these medications. Discontinuing participation in the trial, primarily associated with constipation, occurred more frequently in subjects randomized to CR-oxycodone (27.6%) compared with placebo (6.9%). Treatment with CR-oxycodone reduced the mean worst pain over days 1–8 (p=0.01) and days 1–14 (p=0.02) relative to placebo but not throughout the entire 28-day treatment period as pain resolved in most subjects. Gabapentin did not provide significantly greater pain relief than placebo, although the data for the first week were consistent with a modest benefit. By demonstrating that CR-oxycodone is safe, generally adequately tolerated, and appears to have efficacy for relieving acute pain, the results of this clinical trial provide a foundation for evidence-based treatment for acute pain in herpes zoster.