Monday 23 May 2011

Pregabalin (Lyrica)...

(...Treatments 1)

This is an example of a drug working better for diabetic patients, than for HIV patients, with neuropathy. Like everything else, the study is not definitive but it may be worthwhile discussing these findings with your neurologist or HIV specialist. Because it seems to perform much better against the placebo in the short term, that may be the reason why many HIV patients see the benefits of Lyrica but the findings suggest that the success falls away over a longer period of time.

IAC: Pregabalin Fails to Control HIV Neuropathic Pain Better than Placebo
By Ed Susman, Contributing Writer, MedPage Today
Published: August 08, 2008
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

MEXICO CITY, Aug. 8 -- The anti-convulsant pregabalin (Lyrica) did better than placebo in controlling HIV-related neuropathic pain in the short term, but not over the long haul, researchers found.

Treatment with pregabalin produced a significant reduction in neuropathic pain at two weeks, reducing the NRS-Pain score by two points compared with a 1.5-point decrease in scores among placebo patients (P<0.05), David Simpson, M.D., of Mount Sinai School of Medicine in New York, reported at the International AIDS Conference. However, he said, at the end of the 12-week period 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. "The effect of pregabalin on neuropathic pain in this study was similar to the effect observed in diabetic neuropathy and in post-herpetic neuropathy studies, but in this study there was a far larger placebo effect than the other studies." That negated the difference, Dr. Simpson said. "Placebo effects in these neuropathy studies always cause problems as far as having a successful trial is concerned," said John Mellors, M.D., of the University of Pittsburgh. He said that patient expectation and increases in endorphin levels can interfere with outcomes, especially in trials in which subjective measures of pain are the endpoints. In the pregabalin trial, patients with moderate to severe neuropathic pain secondary to HIV infection or treatment -- 6.7 on a scale of 1 to 10 -- were randomized into two arms, each with 151 individuals. About 80% of the patients were men, with an average age of 48; about 58% were white and about 31% were black. The mean years with an HIV diagnosis was about 13, and patients had complained of neuropathy symptoms for about six years. Although pregabalin was unable to show a difference from placebo in this neuropathy patient population, the drug has also received approval for treatment of pain in diabetic neuropathy patients. The study was sponsored by Pfizer, Inc.
Dr. Simpson has disclosed relationships with Cephalon, NeurogesX, Pfizer and Eli Lilly.
Dr. Mellors has disclosed relationships with Abbott Laboratories, Achillion Pharmaceuticals, Bristol-Myers Squibb, Agouron Pharmaceuticals, Boehringer-Ingelheim, Gilead Sciences, GlaxoSmithKline, Intelligent Therapeutic Solutions, Merck, Noviro/Idenix, Pfizer, Pharmasset, Triangle Pharmaceuticals, Trimeris, Virco-Tibotec and Visible Genetics.

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