Pregabalin for painful HIV neuropathy: A randomized, double-blind, placebo-controlled trial

Neurology

Volumn 74, Issue 5, 2010, Pages 413-420

  Simpson, D M ^a   Schifitto, G ^b   Clifford, D B ^c   Murphy, T K ^d   Durso De Cruz, E ^d   Glue, P ^e   Whalen, E ^d   Emir, B ^d   Scott, G N ^f   Freeman, R ^g  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF ROCHESTER   (United States)

^c WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d Pfizer Global Pharmaceuticals   (United States)

^e UNIVERSITY OF OTAGO   (New Zealand)

^f UBC Scientific Solutions   (United States)

^g BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; PREGABALIN;

ADULT; ARTICLE; CLINICAL TRIAL; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE ASSOCIATION; DISORIENTATION; DISTAL SENSORY POLYNEUROPATHY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EUPHORIA; FATIGUE; FEMALE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN ASSESSMENT; PERIPHERAL EDEMA; POLYNEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SIDE EFFECT; SLEEP; SOMNOLENCE; TREATMENT DURATION; TREATMENT RESPONSE; XEROSTOMIA;

EID: 76349097543     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0b013e3181ccc6ef     Document Type: Article

References (33)

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 DM, Kitch D, Evans SR, et al, ACTG A5117 Study Group. 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, Hoke A, McArthur JC. 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. Gonzalez-Duarte A, Robinson-Papp J, Simpson DM. Diagnosis and management of HIV-associated neuropathy. Neurol Clin 2008;26:821-832.
7. 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.
8. Breitbart W, Passik S, McDonald MV, et al. Patient-related barriers to pain management in ambulatory AIDS patients. Pain 1998;76:9-16.
9. Frich LM, Borgbjerg FM. Pain and pain treatment in AIDS patients: a longitudinal study. J Pain Symptom Manage 2000;19:339-347.
10. Verma S, Estanislao L, Mintz L, Simpson D. Controlling neuropathic pain in HIV. Curr Infect Dis Rep 2004;6: 237-242.
11. Fink K, Dooley DJ, Meder WP, et al. Inhibition of neuronal Ca2+ influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology 2002;42:229-236.
12. Hahn K, Arendt G, Braun JS, et al, German Neuro-AIDS Working Group. A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies. J Neurol 2004;251:1260-1266.
13. RosenstockJ, Tuchman M, LaMoreaux L, SharmaU. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain 2004;110:628-638.
14. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology 2004;63:2104-2110. (Pubitemid 39636259)
15. Richter RW, Portenoy R, Sharma U, LaMoreaux L, Bock-brader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005;6:253-260.
16. Freynhagen R, Strojek K, Griesing T, Whalen E, Balk-enohl M. 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 2005;115:254-263.
17. Tolle T, Freynhagen R, Versavel M, Trostmann U, Young JP Jr. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain 2008;12:203-213.
18. Dworkin RH, Corbin AE, Young JP Jr, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology 2003;60:1274-1283.
19. Sabatowski R, Gálvez R, Cherry DA, et al, 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain 2004;109:26-35.
20. van Seventer R, Feister HA, Young JP Jr, Stoker M, Ver-savel M, Rigaudy L. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin 2006;22:375-384.
21. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology 2006;67:1792-1800.
22. Vranken JH, Dijkgraaf MG, Kruis MR, van der Vegt MH, Hollmann MW, Heesen M. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen. Pain 2008;136:150-157.
23. Crofford LJ, Rowbotham MC, Mease PJ, et al, Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibro-myalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005;52:1264-1273.
24. Mease PJ, Russell IJ, Arnold LM, et al. A randomized, double-blind, placebo-controlled, phase III trial of pre-gabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008;35:502-514.
25. Crofford LJ, Mease PJ, Simpson SL, et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain 2008;136:419-431.
26. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105-121.
27. Amaratunga D, Cabrera J. Mining data to find subsets of high activity. J Stat Plan Inference 2004;122:23-41.
28. LaMotte RH, Shain CN, Simone DA, Tsai EF. Neuro-genic hyperalgesia: psychophysical studies of underlying mechanisms. J Neurophysiol 1991;66:190-211.
29. Ziegler EA, Magerl W, Meyer RA, Treede RD. Secondary hyperalgesia to punctate mechanical stimuli: central sensitiza-tion to A-fibre nociceptor input. Brain 1999;122: 2245-2257.
30. Dworkin RH, Katz J, Gitlin MJ. Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain. Neurology 2005; 65:S7-S19.
31. Khan A, Khan SR, Walens G, et al. Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports. Neuropsychopharma- cology 2003;28:552-557.
32. Kieburtz K, Simpson D, Yiannoutsos C, et al. A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection: AIDS Clinical Trial Group 242 Protocol Team. Neurology 1998;51:1682-1688.
33. Simpson DM, McArthur JC, Olney R, et al, Lamotrigine HIV Neuropathy Study Team. Lamotrigine for HIV-associated painful sensory neuropathies: a placebo-controlled trial. Neurology 2003;60:1508-1514.