A new drug, Lyrica (pregabalin) is a well-tolerated, effective treatment for pain in the extremities often experienced by people with diabetes, according to a recent report. In addition to reducing the pain, the drug seems to improve sleep.

The findings, which appear in the medical journal Neurology, are based on a study sponsored by Pfizer, which markets Lyrica. Just last week, the FDA approved the drug specifically for painful diabetic neuropathy.

The study involved 338 patients with diabetes-related pain who were randomly given Lyrica, at one of three doses, or inactive “placebo” for five weeks.

The intermediate and highest doses of Lyrica, but not the lowest dose, were better than placebo at improving pain, 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.

People who were given Lyrica were also more likely to have a treatment response, meaning that they had a 50 percent or greater improvement in their pain. The two higher doses of Lyrica had responder rates of around 47 percent, whereas the rate with placebo was just 18 percent.

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

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

The results suggest that Lyrica has the potential to become a first-line treatment for diabetes pain, Lesser’s team notes.

SOURCE: Neurology, December 15, 2004.