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Randomized Controlled Trial
. 2010 Feb 2;74(5):413-20.
doi: 10.1212/WNL.0b013e3181ccc6ef.

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

D M Simpson  1 , G Schifitto, D B Clifford, T K Murphy, E Durso-De Cruz, P Glue, E Whalen, B Emir, G N Scott, R Freeman; 1066 HIV Neuropathy Study Group
Affiliations
Randomized Controlled Trial

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

D M Simpson et al. Neurology. .

Abstract

Objective: Pregabalin is effective in several neuropathic pain syndromes. This trial evaluated its efficacy, safety, and tolerability for treatment of painful HIV-associated neuropathy.

Methods: This randomized, double-blind, placebo-controlled, parallel-group trial included a 2-week double-blind dose-adjustment (150-600 mg/day BID) phase, a 12-week double-blind maintenance phase, and an optional 3-month open label extension phase. The primary efficacy measure was the mean Numeric Pain Rating Scale (NPRS) score, an 11-point numeric rating scale. Secondary measures included Patient Global Impression of Change (PGIC) and sleep measurements.

Results: Baseline mean NPRS score was 6.93 for patients randomized to pregabalin (n = 151) and 6.72 for those to placebo (n = 151). Pregabalin average daily dosage (SD) was 385.7 (160.3) mg/d. At endpoint, pregabalin and placebo showed substantial reductions in mean NPRS score from baseline: -2.88 vs -2.63, p = 0.3941. Pregabalin had greater improvements in NPRS score relative to placebo at weeks 1 (-1.14 vs -0.69, p = 0.0131) and 2 (-1.92 vs -1.43, p = 0.0393), and at weeks 7 (-3.22 vs -2.53 p = 0.0307) and 8 (-3.33 vs -2.53, p = 0.0156). At all other time points, differences between groups were not significant. Sleep measurements and 7-item PGIC did not differ among treatment groups; however, collapsed PGIC scores showed 82.8% of pregabalin and 66.7% of placebo patients rated themselves in 1 of the 3 "improved" categories (p = 0.0077). Somnolence and dizziness were the most common adverse events with pregabalin.

Conclusions: Pregabalin was well-tolerated, but not superior to placebo in the treatment of painful HIV neuropathy. Factors predicting analgesic response in HIV neuropathy warrant additional research.

Classification of evidence: This Class II trial showed that pregabalin is not more effective than placebo in treatment of painful HIV neuropathy.

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Figures

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Figure 1 Subject flow through the trial
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Figure 2 Study design and dosing schedule
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Figure 3 Mean change from baseline in Numeric Pain Rating Scale score
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References

    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. - PubMed
    1. 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. - PubMed
    1. 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. - PubMed
    1. Keswani SC, Pardo CA, Cherry CL, Hoke A, McArthur JC. HIV-associated sensory neuropathies. AIDS 2002;16:2105–2117. - PubMed
    1. Verma A. Epidemiology and clinical features of HIV-1 associated neuropathies. J Periph Nerv Syst 2001;6:8–13. - PubMed

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