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Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial.
Neurology. 2010 Feb 02; 74(5):413-20.Neur

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.

Authors+Show Affiliations

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

Pub Type(s)

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

Language

eng

PubMed ID

20124207

Citation

Simpson, D M., et al. "Pregabalin for Painful HIV Neuropathy: a Randomized, Double-blind, Placebo-controlled Trial." Neurology, vol. 74, no. 5, 2010, pp. 413-20.
Simpson DM, Schifitto G, Clifford DB, et al. Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial. Neurology. 2010;74(5):413-20.
Simpson, D. M., Schifitto, G., Clifford, D. B., Murphy, T. K., Durso-De Cruz, E., Glue, P., Whalen, E., Emir, B., Scott, G. N., & Freeman, R. (2010). Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial. Neurology, 74(5), 413-20. https://doi.org/10.1212/WNL.0b013e3181ccc6ef
Simpson DM, et al. Pregabalin for Painful HIV Neuropathy: a Randomized, Double-blind, Placebo-controlled Trial. Neurology. 2010 Feb 2;74(5):413-20. PubMed PMID: 20124207.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial. AU - Simpson,D M, AU - Schifitto,G, AU - Clifford,D B, AU - Murphy,T K, AU - Durso-De Cruz,E, AU - Glue,P, AU - Whalen,E, AU - Emir,B, AU - Scott,G N, AU - Freeman,R, AU - ,, PY - 2010/2/4/entrez PY - 2010/2/4/pubmed PY - 2010/2/20/medline SP - 413 EP - 20 JF - Neurology JO - Neurology VL - 74 IS - 5 N2 - 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. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/20124207/Pregabalin_for_painful_HIV_neuropathy:_a_randomized_double_blind_placebo_controlled_trial_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=20124207 DB - PRIME DP - Unbound Medicine ER -