Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy

Neurology

Volumn 70, Issue 24, 2008, Pages 2305-2313

  Simpson, David M ^a,b   Brown, Stephen ^c   Tobias, Jeffrey ^d  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b MOUNT SINAI MEDICAL CENTER   (United States)

^c AIDS Research Alliance   (United States)

^d NeurogesX Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CAPSAICIN; ANALGESIC AGENT; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HIV ASSOCIATED DISTAL SENSORY POLYNEUROPATHY; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROPATHY; NOCICEPTION; OPEN STUDY; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SINGLE DRUG DOSE; SKIN MANIFESTATION; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; AGED; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTRADERMAL DRUG ADMINISTRATION; MIDDLE AGED; PAIN; PATHOPHYSIOLOGY; POLYNEUROPATHY; QUESTIONNAIRE;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; ANALGESICS, NON-NARCOTIC; CAPSAICIN; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; PAIN; PAIN MEASUREMENT; PLACEBOS; POLYNEUROPATHIES; QUESTIONNAIRES; TREATMENT OUTCOME;

EID: 46049111268     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/01.wnl.0000314647.35825.9c     Document Type: Article

References (40)

1. Morgello S, Estanislao L, Simpson D, et al. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: the Manhattan HIV Brain Bank. Arch Neurol 2004;61:546-551.
2. Simpson D, Evans S, Kitch D, et al. HIV neuropathy natural history cohort study: Assessment measures and risk factors. Neurology 2006;66:1679-1687.
3. Simpson DM, Tagliati M. Nucleoside analogue-associated peripheral neuropathy in human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol 1995;9:153-161.
4. Keswani SC, Pardo CA, Cherry CL, et al. HIV-associated sensory neuropathies. AIDS 2002;16:2105-2117.
5. Verma A. Epidemiology and clinical features of HIV-1 associated neuropathies. J Periph Nerv Syst 2001;6:8-13.
6. Breitbart W, Rosenfeld BD, Passik SD, McDonald MV, Thaler H, Portenoy RK. The undertreatment of pain in ambulatory AIDS patients. Pain 1996;65:243-249.
7. Breitbart W, Passik S, McDonald MV, et al. Patient-related barriers to pain management in ambulatory AIDS patients. Pain 1998;76:9-16.
8. Frich LM, Borgbjerg FM. Pain and pain treatment in AIDS patients: a longitudinal study. J Pain Symptom Manage 2000;19:339-347.
9. Verma S, Estanislao L, Mintz L,et al. Controlling neuropathic pain in HIV. Curr Infect Dis Rep 2004;6:237-242.
10. Cortright DN, Szallasi A. Biochemical pharmacology of the vanilloid receptor TRPV1. An update. Eur J Biochem 2004;271:1814-1819.
11. Bley KR. Recent developments in transient receptor potential vanilloid receptor 1 agonist-based therapies. Exp Opin Invest Drugs 2004;13:1445-1456.
12. Zhang WY, LiWan Po A. The effectiveness of topically applied capsaicin. A meta-analysis. Eur J Clin Pharmacol 1994;46:517-522.
13. Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain 1997;73:123-139.
14. Paice JA, Ferrans CE, Lashley FR, et al. Topical capsa-icin in the management of HIV-associated peripheral neuropathy. J Pain Symptom Manage 2000;19:45-52.
15. Dray A. Neuropharmacological mechanisms of capsaicin and related substances. Biochem Pharmacol 1992; 44:611-615.
16. Robbins WR, Staats PS, Levine J, et al. Treatment of intractable pain with topical large-dose capsaicin: preliminary report. Anesth Analg 1998;86:579-583.
17. Simpson DM, Estanislao L, Brown SJ, Sampson J. An open-label pilot study of high-concentration capsaicin patch in painful HIV neuropathy. J Pain Symptom Manage Epub 2007 Oct 22.
18. Gracely RH, McGrath F, Dubner R. Ratio scales of sensory and affective verbal pain descriptors. Pain 1978;5:5-18.
19. Melzack R. The short-form McGill Pain Questionnaire. Pain 1987;30:191-197.
20. Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 1983;17:197-210.
21. Guidance for Industry: Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 1999. Available at: http://www.fda. gov/ohrms/dockets/98fr/990236Gd. pdf#search=%22 HillTop%20Research%2C%20Inc.%20dermal%20 irritation%22. Accessed August 15, 2007.
22. Pardo CA, McArthur JC, Griffin JW. HIV neuropathy: Insights in the pathology of HIV peripheral nerve disease. J Periph Nerv Syst 2001;6:21-27.
23. Martin C, Solders G, Sonnerborg A, Hansson P. Painful and non-painful neuropathy in HIV-infected patients: an analysis of somatosensory nerve function. Eur J Pain 2003;7:23-31.
24. Schiffito G, Yiannoutsos CT, Simpson DM, et al. A placebo-controlled study of memantine for the treatment of HIV-associated sensory neuropathy. J Neurovirol 2006;12:328-331.
25. Pettersen JA, Jones G, Worthington C, et al. Sensory neuropathy in human immunodeficiency virus/acquired immunodeficiency syndrome patients: protease inhibitor-mediated neurotoxicity. Ann Neurol 2006;59: 816-824.
26. Simpson DM, Dorfman D, Olney RK, et al. Peptide T in the treatment of painful distal neuropathy associated with AIDS: results of a placebo-controlled trial. Neurology 1996;47:1254-1259.
27. Evans S, Simpson D, Kitch D, et al. Phase II trial of Prosaptide™ prosaposin-derived peptides for HIV-associated sensory neuropathies: first use of electronic diary to record HIV-associated neuropathic pain. Presented at: 13th Conference on Retroviruses and Opportunistic Infections; February 6, 2006; Denver, CO. Abstract.
28. McArthur JC, Yiannoutsos C, Simpson DM, et al. A phase II trial of recombinant human nerve growth factor for sensory neuropathy associated with HIV infection. Neurology 2000;54:1080-1088.
29. Kieburtz K, Simpson DM,and the ACTG 242 Study Team. A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. Neurology 1998;51:1682-1688.
30. Schlay JC, Chaloner K, Max MB, et al. Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. JAMA 1998;280:1590-1595.
31. Estanislao L, Olney R, McArthur J, and the Lidoderm HIV neuropathy study group. A randomized placebo-controlled trial of 5% lidocaine gel for HIV-associated distal symmetric polyneuropathy. J AIDS 2004;37: 1584-1586.
32. Simpson DM, Olney R, McArthur JC, et al. Lam-otrigine in the treatment of painful HIV-associated peripheral neuropathy: a randomized, placebo-controlled trial. Neurology 2003;60:1508-1514.
33. Hahn K, Arendt G, Braun JS, et al. A placebocontrolled trial of gabapentin for painful HIV- associated sensory neuropathies. J Neurol 2004;251: 1260-1266.
34. Abrams DI, Jay CA, Shade SB, et al. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology 2007;68:515-521.
35. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30.
36. Simpson D, Brown S, Tobias J. Treatment of Painful HIV-Associated Distal Sensory Polyneuropathy (DSP) with a High-Concentration Capsaicin Dermal Patch (NGX-4010): Report of a 52-Week Study. Presented at the 59th American Academy of Neurology annual meeting; April 27-May 5, 2007; Boston, MA. Abstract 2712.
37. Nolano M, Simone DA, Wendelschafer-Crabb G, et al. Topical capsaicin in humans: parallel loss of epidermal nerve fibers and pain sensation. Pain 1999;81: 135-145.
38. Lee YS, Kho HS, Kim YK, Chung SC. Influence of topical capsaicin on facial sensitivity in response to experimental pain. J Oral Rehabil 2007;34:9-14.
39. Backonja MM, Irving GA, Argoff CE. Rational multi-drug therapy in the treatment of neuropathic pain. Curr Pain Headache Rep 2006;10:34-38.
40. Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 2005;352: 1324-1334.