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An open-label pilot study of high-concentration capsaicin patch in painful HIV neuropathy.
J Pain Symptom Manage. 2008 Mar; 35(3):299-306.JP

Abstract

Peripheral neuropathy is the most frequent neurological complication of human immunodeficiency virus (HIV)-1 infection and is commonly associated with the development of chronic pain. This open-label, 12-week pilot study assessed the efficacy, tolerability, and safety of a high-concentration capsaicin dermal patch (NGX-4010; capsaicin, 640microg/cm2, 8% w/w) to treat painful HIV-associated distal sensory polyneuropathy (DSP). Eligible patients had moderate-to-severe pain in both feet due to HIV-associated DSP or antiretroviral toxic neuropathy. Patients received a single 60-minute application of the investigational high-concentration capsaicin patch to the affected areas. The primary outcome measure was the mean percent change in numeric pain rating scale (NPRS) during weeks two to 12 postadministration. After a single 60-minute NGX-4010 application, the mean percent change from baseline in "average pain for past 24 hours" NPRS scores during weeks two to 12 was -40% (95% CI: -61%, -19%; P=0.0020). Similar results were observed for "worst pain for past 24 hours" and "pain now" scores. Eight of 12 patients (67%) were treatment responders (> or =30% pain decrease). Four of 12 patients (33%) experienced a > or =50% reduction in pain. Treatment was generally well tolerated. Treatment-associated pain was self-limited and could be managed with short-acting opioids. This study demonstrates that treatment of painful HIV-associated neuropathy with a single application of NGX-4010, a high-concentration capsaicin patch, was feasible, well tolerated, and associated with significant reduction in pain over the 12 weeks studied. No safety concerns were identified. Controlled studies of NGX-4010 for the treatment of painful HIV-associated neuropathy are warranted.

Authors+Show Affiliations

Mount Sinai School of Medicine, New York, NY 10029, USA. david.simpson@mssm.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17959343

Citation

Simpson, David M., et al. "An Open-label Pilot Study of High-concentration Capsaicin Patch in Painful HIV Neuropathy." Journal of Pain and Symptom Management, vol. 35, no. 3, 2008, pp. 299-306.
Simpson DM, Estanislao L, Brown SJ, et al. An open-label pilot study of high-concentration capsaicin patch in painful HIV neuropathy. J Pain Symptom Manage. 2008;35(3):299-306.
Simpson, D. M., Estanislao, L., Brown, S. J., & Sampson, J. (2008). An open-label pilot study of high-concentration capsaicin patch in painful HIV neuropathy. Journal of Pain and Symptom Management, 35(3), 299-306.
Simpson DM, et al. An Open-label Pilot Study of High-concentration Capsaicin Patch in Painful HIV Neuropathy. J Pain Symptom Manage. 2008;35(3):299-306. PubMed PMID: 17959343.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label pilot study of high-concentration capsaicin patch in painful HIV neuropathy. AU - Simpson,David M, AU - Estanislao,Lydia, AU - Brown,Stephen J, AU - Sampson,James, Y1 - 2007/10/23/ PY - 2006/12/28/received PY - 2007/04/01/revised PY - 2007/04/09/accepted PY - 2007/10/26/pubmed PY - 2008/4/25/medline PY - 2007/10/26/entrez SP - 299 EP - 306 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 35 IS - 3 N2 - Peripheral neuropathy is the most frequent neurological complication of human immunodeficiency virus (HIV)-1 infection and is commonly associated with the development of chronic pain. This open-label, 12-week pilot study assessed the efficacy, tolerability, and safety of a high-concentration capsaicin dermal patch (NGX-4010; capsaicin, 640microg/cm2, 8% w/w) to treat painful HIV-associated distal sensory polyneuropathy (DSP). Eligible patients had moderate-to-severe pain in both feet due to HIV-associated DSP or antiretroviral toxic neuropathy. Patients received a single 60-minute application of the investigational high-concentration capsaicin patch to the affected areas. The primary outcome measure was the mean percent change in numeric pain rating scale (NPRS) during weeks two to 12 postadministration. After a single 60-minute NGX-4010 application, the mean percent change from baseline in "average pain for past 24 hours" NPRS scores during weeks two to 12 was -40% (95% CI: -61%, -19%; P=0.0020). Similar results were observed for "worst pain for past 24 hours" and "pain now" scores. Eight of 12 patients (67%) were treatment responders (> or =30% pain decrease). Four of 12 patients (33%) experienced a > or =50% reduction in pain. Treatment was generally well tolerated. Treatment-associated pain was self-limited and could be managed with short-acting opioids. This study demonstrates that treatment of painful HIV-associated neuropathy with a single application of NGX-4010, a high-concentration capsaicin patch, was feasible, well tolerated, and associated with significant reduction in pain over the 12 weeks studied. No safety concerns were identified. Controlled studies of NGX-4010 for the treatment of painful HIV-associated neuropathy are warranted. SN - 0885-3924 UR - https://www.unboundmedicine.com/medline/citation/17959343/An_open_label_pilot_study_of_high_concentration_capsaicin_patch_in_painful_HIV_neuropathy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(07)00562-3 DB - PRIME DP - Unbound Medicine ER -