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Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy.
Neurology. 2008 Jun 10; 70(24):2305-13.Neur

Abstract

BACKGROUND

HIV-associated distal sensory polyneuropathy (HIV-DSP) is a painful condition with limited effective treatment. Capsaicin desensitizes cutaneous nociceptors resulting in reduced pain. We report a placebo-controlled study of a high-concentration capsaicin dermal patch (NGX-4010) for the treatment of painful HIV-DSP.

METHODS

This double-blind multicenter study randomized 307 patients with painful HIV-DSP to receive NGX-4010 or control, a low-concentration capsaicin patch. After application of a topical anesthetic, NGX-4010 or control was applied once for 30, 60, or 90 minutes to painful areas on the feet. The primary efficacy endpoint was percent change in Numeric Pain Rating Scale (NPRS) from baseline in mean "average pain for past 24 hours" scores from weeks 2 to 12.

RESULTS

A single NGX-4010 application resulted in a mean pain reduction of 22.8% during weeks 2 to 12 as compared to a 10.7% reduction for controls (p = 0.0026). Following a transient treatment-related pain increase, pain was reduced; significant improvement was apparent by week 2 and continued throughout the controlled 12-week observation period. Mean pain reductions in the NGX-4010 30-, 60- and 90-minute groups were 27.7%, 15.9%, and 24.7% (p = 0.0007, 0.287, and 0.0046 vs control). One third of NGX-4010-treated patients reported >or=30% pain decrease from baseline as compared to 18% of controls (p = 0.0092). Self-limited, mild-to-moderate local skin reactions were commonly observed.

CONCLUSIONS

A single NGX-4010 application was safe and provided at least 12 weeks of pain reduction in patients with HIV-associated distal sensory polyneuropathy. These results suggest that NGX-4010 could provide a promising new treatment for painful HIV neuropathy.

Authors+Show Affiliations

Clinical Neurophysiology Laboratories and Neuro-AIDS Program, The Mount Sinai Medical Center, New York, NY 10029, USA. david.simpson@mssm.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18541884

Citation

Simpson, David M., et al. "Controlled Trial of High-concentration Capsaicin Patch for Treatment of Painful HIV Neuropathy." Neurology, vol. 70, no. 24, 2008, pp. 2305-13.
Simpson DM, Brown S, Tobias J, et al. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008;70(24):2305-13.
Simpson, D. M., Brown, S., & Tobias, J. (2008). Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology, 70(24), 2305-13. https://doi.org/10.1212/01.wnl.0000314647.35825.9c
Simpson DM, et al. Controlled Trial of High-concentration Capsaicin Patch for Treatment of Painful HIV Neuropathy. Neurology. 2008 Jun 10;70(24):2305-13. PubMed PMID: 18541884.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. AU - Simpson,David M, AU - Brown,Stephen, AU - Tobias,Jeffrey, AU - ,, PY - 2008/6/11/pubmed PY - 2008/7/3/medline PY - 2008/6/11/entrez SP - 2305 EP - 13 JF - Neurology JO - Neurology VL - 70 IS - 24 N2 - BACKGROUND: HIV-associated distal sensory polyneuropathy (HIV-DSP) is a painful condition with limited effective treatment. Capsaicin desensitizes cutaneous nociceptors resulting in reduced pain. We report a placebo-controlled study of a high-concentration capsaicin dermal patch (NGX-4010) for the treatment of painful HIV-DSP. METHODS: This double-blind multicenter study randomized 307 patients with painful HIV-DSP to receive NGX-4010 or control, a low-concentration capsaicin patch. After application of a topical anesthetic, NGX-4010 or control was applied once for 30, 60, or 90 minutes to painful areas on the feet. The primary efficacy endpoint was percent change in Numeric Pain Rating Scale (NPRS) from baseline in mean "average pain for past 24 hours" scores from weeks 2 to 12. RESULTS: A single NGX-4010 application resulted in a mean pain reduction of 22.8% during weeks 2 to 12 as compared to a 10.7% reduction for controls (p = 0.0026). Following a transient treatment-related pain increase, pain was reduced; significant improvement was apparent by week 2 and continued throughout the controlled 12-week observation period. Mean pain reductions in the NGX-4010 30-, 60- and 90-minute groups were 27.7%, 15.9%, and 24.7% (p = 0.0007, 0.287, and 0.0046 vs control). One third of NGX-4010-treated patients reported >or=30% pain decrease from baseline as compared to 18% of controls (p = 0.0092). Self-limited, mild-to-moderate local skin reactions were commonly observed. CONCLUSIONS: A single NGX-4010 application was safe and provided at least 12 weeks of pain reduction in patients with HIV-associated distal sensory polyneuropathy. These results suggest that NGX-4010 could provide a promising new treatment for painful HIV neuropathy. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/18541884/Controlled_trial_of_high_concentration_capsaicin_patch_for_treatment_of_painful_HIV_neuropathy_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=18541884 DB - PRIME DP - Unbound Medicine ER -