Pregabalin No Better Than Placebo in Treating HIV-Associated Neuropathic Pain: Presented at AIDS 2008

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Title: Pregabalin No Better Than Placebo in Treating HIV-Associated Neuropathic Pain: Presented at AIDS 2008
URL: http://www.pslgroup.com/dg/2278C6.htm
Doctor's Guide
August 8, 2008

By Ed Susman

MEXICO CITY -- August 8, 2008 -- Pregabalin, an anticonvulsant used for treatment of diabetic neuropathic pain, failed to prove better than placebo among patients with human immunodeficiency (HIV)-associated peripheral neuropathic pain, researchers stated here at the 17th International AIDS Conference (AIDS 2008).

While pregabalin reduced pain among patients in the 14-week study, the placebo effect nearly equaled that of the active drug, creating a nonsignificant difference in results.

"The effect of pregabalin on neuropathic pain in this study was similar to the effect observed in diabetic neuropathy and in postherpetic neuropathy studies," said David Simpson, MD, Mount Sinai School of Medicine, New York, New York. "In this study, [there] was a far larger placebo effect than [in] the other studies, and that negated the difference."

In an oral late-breaker presentation on August 7, Dr. Simpson said that treatment with pregabalin produces a significant reduction in neuropathic pain at 2 weeks, reducing the NRS-Pain score by 2 points compared with a 1.5-point decrease in scores among placebo patients (P < .05).

At the end of the 14-week period, however, the pain reduction among pregabalin patients was about 3.2 points compared with 2.5 points among placebo patients -- a difference that did not reach statistical significance, Dr. Simpson said. In this trial, patients with moderate to severe neuropathic pain secondary to HIV infection or treatment -- 6.7 on a scale of 1 to 10 -- were randomised into 2 arms, each with 151 individuals.

Dr. Simpson noted that the placebo effect can be unpredictable. In one trial, for example, capsaicin proved superior to placebo in controlling neuropathic pain; but in a second trial, capsaicin was equally effective in pain reduction -- but the trial failed because the placebo effect was just as potent.

About 80% of the patients in the pregabalin trial were men with an average age of 48 years; about 58% were white and about 31% were black. The mean time subjects had had an HIV diagnosis was approximately 13 years, and patients had complained of neuropathy symptoms for about 6 years.

[Presentation title: Pregabalin in HIV-Associated Painful Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study (Study A0081066). Abstract title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Pregabalin vs Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy. Abstract: THAB0301]

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