Hostname: page-component-586b7cd67f-2plfb Total loading time: 0 Render date: 2024-11-22T18:42:27.883Z Has data issue: false hasContentIssue false
  • English
  • Français

Randomized Clinical Trials of Pregabalin for Neuropathic Pain: Methods, Results, and Implications

Published online by Cambridge University Press:  25 September 2007

Robert H. Dworkin ,
Rajbala Thakur ,
Teresa Griesing ,
Uma Sharma  and
James P. Young
Robert H. Dworkin
Affiliation:
Departments of Anesthesiology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA; Email: [email protected]
Rajbala Thakur
Affiliation:
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA; Email: [email protected]
Teresa Griesing
Affiliation:
Pfizer, Inc., New York, NY, USA; Email: [email protected]
Uma Sharma
Affiliation:
Pfizer, Inc., Ann Arbor, MI, USA; Email: [email protected]
James P. Young
Affiliation:
Pfizer, Inc., Ann Arbor, MI, USA; Email: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'

Keywords

diabetic peripheral neuropathyneuropathic painpostherpetic neuralgiapregabalinrandomized clinical trialsspinal cord injury
Type
Research Article
Information
Progress in Neurotherapeutics and Neuropsychopharmacology , Volume 3 , Issue 1 , January 2008 , pp. 167 - 187
Copyright
© 2008 Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Argoff, C.E., Backonja, M.-M., Belgrade, M.J., Bennett, G.J., Clark, M.R., Cole, B.E., et al. (2006). Consensus guidelines: treatment planning and options. Mayo Clinic Proceedings, 81 (Suppl.), S12–S25.Google Scholar
Belliotti, T., Ekhato, I.V., Capiris, T., Kinsora, J., Vartanian, M.G., Field, M., et al. (2005). Structure–activity relationships of pregabalin and analogs that target the α2–δ protein. Journal of Medicinal Chemistry, 48, 2294–2307.Google Scholar
Bowsher, D. (1999). The lifetime occurrence of herpes zoster and prevalence of postherpetic neuralgia: a retrospective survey in an elderly population. European Journal of Pain, 3, 335–342.Google Scholar
Crofford, L.J., Rowbotham, M.C., Mease, P.J., Russell, I.J., Dworkin, R.H., Corbin, A.E., et al. (2005). Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis and Rheumatism, 52, 1264–1273.Google Scholar
Dooley, D.J., Taylor, C.P., Donevan, S., & Feltner, D. (2007). Ca2+ channel α2δ ligands: novel modulators of neurotransmission. Trends in Pharmacological Sciences, 28, 75–82.Google Scholar
Dubinsky, R.M., Kabbani, H., El-Chami, Z., Boutwell, C., & Ali, H. (2004). Practice parameter: treatment of postherpetic neuralgia: an evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 63, 959–965.Google Scholar
Dworkin, R.H., Backonja, M., Rowbotham, M.C., Allen, R.R., Argoff, C.R., Bennett, G.J., et al. (2003a). Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Archives of Neurology, 60, 1524–1534.Google Scholar
Dworkin, R.H., Corbin, A.E., Young, Jr., J.P., Sharma, U., LaMoreaux, L., Bockbrader, H., et al. (2003b). Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology, 60, 1274–1283.Google Scholar
Dworkin, R.H., Fields, H.L., & Levine, J.D. (eds.) (2005a). Is fibromyalgia a neuropathic pain syndrome? Journal of Rheumatology, 32(Suppl. 75), 1–45.
Dworkin, R.H., Katz, J., & Gitlin, M.J. (2005b). Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain. Neurology, 65 (Suppl. 4), S7–S19.Google Scholar
Dworkin, R.H., Sharma, U., Young, J., & LaMoreaux, L. (2005c). Pain relief with pregabalin in postherpetic neuralgia (PHN) is not influenced by concomitant medications. Journal of Pain, 6 (Suppl. 1), S32.Google Scholar
Dworkin, R.H., Turk, D.C., Farrar, J.T., Haythornthwaite, J.A., Jensen, M.P., Katz, N.P., et al. (2005d). Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain, 113, 9–19.Google Scholar
Dworkin, R.H., O'Connor, A.B., Backonja, M., Farrar, J.T., Jensen, T.S., Kalso, E.A., et al. (in press). Pharmacologic management of neuropathic pain: evidence-based clinical recommendations. Pain.
Farrar, J.T., Young, J.P., LaMoreaux, L., Werth, J.L., & Poole, M. (2001). Clinical importance of changes in chronic pain intensity on an 11-point numerical pain rating scale. Pain, 94, 149–158.Google Scholar
Farrar, J.T., Dworkin, R.H., & Max, M.B. (2006). Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: making clinical trial data more understandable. Journal of Pain and Symptom Management, 31, 369–377.Google Scholar
Field, M.J., Cox, P.J., Stott, E., Melrose, H., Offord, J., Su, T., et al. (2006). Identification of the α2–δ–1 subunit of voltage dependent calcium channels as a novel molecular target for pain mediating the analgesic actions of pregabalin. Proceedings of the National Academy of Sciences USA, 103, 17537–17542.Google Scholar
Finnerup, N.B., Otto, M., Jensen, T.S., & Sindrup, S.H. (2005). Algorithm for neuropathic pain treatment: an evidence based proposal. Pain, 118, 289–305.Google Scholar
Freynhagen, R., Strojek, K., Griesing, T., Whalen, E., & Balkenohl, M. (2005). Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain, 115, 254–263.Google Scholar
Goldstein, D.J., Lu, Y., Detke, M.J., Lee, T.C., & Iyengar, S. (2005). Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain, 116, 109–118.Google Scholar
Guy, W. (1976). ECDEU Assessment Manual for Psychopharmacology (DHEW Publication No. ADM 76–338). Washington, DC: U.S. Government Printing Office.
Hempenstall, K., Nurmikko, T.J., Johnson, R.W., A'Hern, R.P., & Rice, A.S.C. (2005). Analgesic therapy in postherpetic neuralgia: a quantitative systematic review. PLOS Medicine, 2, 628–644.Google Scholar
IASP Special Interest Group on Neuropathic Pain (2006). Classification and taxonomy. Neuropathic Pain: Newsletter of the IASP Special Interest Group on Neuropathic Pain, Issue 7.Google Scholar
Jensen, M.P., Chodroff, M.J., & Dworkin, R.H. (2007). The impact of neuropathic pain on health-related quality of life: review and implications. Neurology, 68, 1178–1182.Google Scholar
Kieburtz, K., Simpson, D., Yiannoutsos, C., Max, M.B., Hall, C.D., Ellis, R.J., et al. (1998). A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. Neurology, 51, 1682–1688.Google Scholar
Lesser, H., Sharma, U., LaMoreaux, L., & Poole, R.M. (2004). Pregabalin relieves symptoms of painful diabetic neuropathy. Neurology, 63, 2104–2110.Google Scholar
Melzack, R. (1987). The short-form McGill Pain Questionnaire. Pain, 30, 191–197.Google Scholar
Merskey, H., & Bogduk, N. (eds.) (1994). Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms (2nd ed.). Seattle, WA: IASP Press, p. 212.
Moscucci, M., Byrne, L., Weintraub, M., & Cox, C. (1987). Blinding, unblinding, and the placebo effect: an analysis of patients' guesses of treatment assignment in a double-blind clinical trial. Clinical Pharmacology and Therapeutics, 41, 259–265.Google Scholar
Oster, G., Harding, G., Dukes, E., Edelsberg, J., & Cleary, P.D. (2005). Pain, medication use and health-related quality of life in older persons with post-herpetic neuralgia: results from a population-based survey. Journal of Pain, 6, 356–363.Google Scholar
Raskin, J., Pritchett, Y.L., Wang, F., D'Souza, D.N., Waninger, A.L., Iyengar, S., et al. (2005). A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Medicine, 6, 346–356.Google Scholar
Rice, A.S.C., & Maton, S. (2001). Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain, 94, 215–224.Google Scholar
Richter, R.W., Portenoy, R., Sharma, U., Lamoreaux, L., Bockbrader, H., & Knapp, L.E. (2005). Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. Journal of Pain, 6, 253–260.Google Scholar
Rosenstock, J., Tuchman, M., LaMoreaux, L., & Sharma, U. (2004). Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain, 110, 628–638.Google Scholar
Rowbotham, M., Young, J.R., Sharma, U., & Knapp, L.K. (2003). Pregabalin shows reduction in pain by day 3 of treatment. European Journal of Neurology, 10 (Suppl. 1), 73.Google Scholar
Rowbotham, M.C., Harden, N., Stacey, B., Bernstein, P., & Magnus-Miller, L. (1998). Gabapentin for the treatment postherpetic neuralgia: a randomized controlled trial. JAMA, 280, 1837–1842.Google Scholar
Sabatowski, R., Galvez, R., Cherry, D.A., Jacquot, F., Vincent, E., Maisonobe, M., et al. (2004). Pregabalin reduces pain and improved sleep and mood disturbances in patients with postherpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain, 109, 26–35.Google Scholar
Schmader, K.E. (2002). The epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clinical Journal of Pain, 18, 350–354.Google Scholar
Sharma, U., Young, J., LaMoreaux, L., Emir, B., Fukui, A., Murphy, T.K., & Siffert, J. (2005) Efficacy, safety, and tolerability of pregabalin treatment for neuropathic pain: findings from the analysis of 10 randomized clinical trials. Presented at the meeting of the American Academy of Physical Medicine and Rehabilitation, 27–30 October 2005, Philadelphia, Pennsylvania.
Shlay, J.C., Chaloner, K., Max, M.B., Flaws, B., Reichelderfer, P., Wentworth, D., et al. (1998). Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. JAMA, 280, 1590–1595.Google Scholar
Siddall, P.J., Cousins, M.J., Otte, A., Griesing, T., Chambers, R., & Murphy, T.K. (2006). Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology, 67, 1792–1800.Google Scholar
Taylor, C.P., Angelotti, T., & Fauman, E. (2007). Pharmacology and mechanism of action of pregabalin: the calcium channel α2–δ (alpha2–delta) subunit as a target for antiepileptic drug discovery. Epilepsy Research, 73, 137–150.Google Scholar
Turk, D.C., Dworkin, R.H., Allen, R.R., Bellamy, N., Brandenburg, N., Carr, D.B., et al. (2003). Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain, 106, 337–345.Google Scholar
Turk, D.C., Dworkin, R.H., Burke, L.B., Gershon, R., Rothman, M., Scott, J., et al. (2006). Developing outcome measures for pain clinical trials: IMMPACT recommendations. Pain, 125, 208–215.Google Scholar
Van Seventer, R., Feister, H.A., Young, Jr., J.P., Stoker, M., Versavel, M., & Rigaudy, L. (2006). Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Current Medical Research and Opinion, 22, 375–384.Google Scholar
Ware, Jr., J.E., Snow, K.K., Kosinski, M., & Gandek, B. (1992). SF-36-item Short Form Health Survey (SF-36): I. conceptual framework and item selection. Medical Care, 30, 473–483.Google Scholar
Wernicke, J.F., Pritchett, Y.L., D'Souza, D.N., Waninger, A., Tran, P., Iyengar, S., et al. (2006). A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology, 67, 1411–1420.Google Scholar
Woolf, C.J. (2004). Pain: moving from symptom control toward mechanism-specific pharmacologic management. Annals of Internal Medicine, 140, 441–451.Google Scholar