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Pregabalin Relieves Pain of Diabetic Neuropathy

Lyrica (Pregabalin), just approved by the FDA was found to be a well-tolerated, effective treatment for the neuropathic pain and also improved sleep.

The study involved 338 patients with DPN-related pain who were randomized to receive pregabalin, at one of three doses, or placebo for 5 weeks.

The 300- and 600-mg/day doses of pregabalin, but not the 75-mg/day dose, were significantly better than placebo at improving the average pain score at 5 weeks (p = 0.0001), lead author Dr. Harold Lesser, from the University of Rochester School of Medicine & Dentistry in New York, and colleagues note. These doses were also tied to significant improvements in sleep and quality of life.

Treatment responders were defined as patients who experienced a 50% or greater reduction in pain from baseline. The two higher doses of pregabalin had responder rates around 47%, whereas the rate with placebo was just 18%.

The improvements in pain and sleep were noted within 1 week of treatment with pregabalin and persisted throughout the study, the investigators point out.

Treatment with pregabalin was well tolerated and side effects were generally mild, most commonly dizziness and somnolence, the report indicates.

"The efficacy profile for pregabalin was both statistically and clinically significant and is in the same range as other drugs of first choice currently used to treat neuropathic pain associated with NPN," Dr. Lesser’s team notes. The drug’s pharmacokinetic properties will likely make it easier to prescribe than gabapentin, a structurally related agent that is widely used to treat such pain, they add.

Neurology 2004;63:2104-2110.

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Hypertension. 2005;45:2-21