Recent findings suggest that pregabalin may help reduce pain and improve the quality of sleep in fibromyalgia patients. The study, “The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain,” was published in the Current Medical Research and Opinion journal.

Fibromyalgia affects 2 to 8 percent of the world’s population. The syndrome is identified by widespread muscle pain that intensifies upon pressure and is often accompanied by a number of symptoms, including sleep disturbances. Like a number of other medically unexplained syndromes, fibromyalgia has no cure, but can be managed in various ways, including medications. Among them, pregabalin is a drug approved for the treatment of fibromyalgia in Canada and the United States.

“Pregabalin is a therapy approved for the treatment of fibromyalgia pain in multiple countries worldwide, and its efficacy for the treatment of fibromyalgia-related pain has been demonstrated in several double-blind, randomized, placebo-controlled clinical trials,” Andrew Clair, Ph.D., and Birol Emir, Ph.D., both with Pfizer in New York, wrote in a press release.

Researchers evaluated the efficacy of pregabalin in terms of pain and sleep changes through 12 weeks of treatment.  They collected and analyzed data from five Phase 3 trials of adult fibromyalgia patients with moderate-to-severe baseline pain: 1,605 patients treated with 300 mg. to 450 mg. of pregabalin, and 929 individuals with placebo.

“These clinical trials enrolled subjects with moderate or severe fibromyalgia pain at baseline; however, determining differences in the efficacy and safety of pregabalin stratified by disease severity was not a prespecified analysis. Moreover, we are not aware of any other studies that have evaluated the efficacy or safety of pregabalin for fibromyalgia-related pain by differences in baseline pain in severity categories (eg, moderate vs. severe),” researchers wrote.

They found that all participants showed decreased pain as well as improved sleep quality noticeable from weeks 8-12. The improvements were more substantial in patients treated with pregabalin and with baseline severe pain. Furthermore, pregabalin was found to be overall well-tolerated by the patients and side effects were consistent with those reported in previous trials.

“Pregablin was found to be efficacious and generally well tolerated as a treatment for reducing pain in subjects with fibromyalgia regardless of baseline pain severity,” Clair and Emir wrote.

“These reductions in pain appeared greater in subjects with severe compared with moderate baseline pain, whereas the incidence of [adverse effects] remained consistent with the known safety profile of pregabalin and was comparable between subjects, irrespective of baseline pain severity,” they wrote.