Instituut voor Neuropathische Pijn

Bottom line In this study, patients with HIV-associated peripheral neuropathy taking pregabalin (Lyrica) had no more pain relief than patients taking placebo. (Level of evidence = 2b)

Synopsis In this industry-sponsored study, patients with HIV-associated peripheral neuropathy for more than 3 months and with medication regimens that were unchanged for at least 3 months were randomly assigned to receive pregabalin (n = 151) or matching placebo (n = 151). The patients also had to have completed at least four daily pain diary entries during the last 7 days of a 2-week screening period. Once randomized, patients participated in a 2-week dose adjustment period. They were started on pregabalin: 75 mg twice a day (or matching placebo). After 3 days, depending on pain response, the dose was maintained or the end of the first and second weeks, the dose was titrated up or down based on symptoms, with a maximum dose of 300 mg twice a day. The dose adjustment at the end of 2 weeks was considered final, and the patient was reevaluated after 12 weeks. The authors used intention-to-treat analysis to assess the study outcomes. Sixty-one patients stopped participating in the study prematurely. For these patients, the researchers carried forward the last observation. This is a popular method, but it can infl ate the effect estimates. At the end of the study, the amount of pain relief on a scale of 0 to 10 was similar in both groups. Simpson DM, Schifitto G, Clifford DB, et al; 1066 HIV Neuropathy Study Group. Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial. Neurology. 2010;74(5):413-420.