Pregabalin was effective in reducing pain and improving sleep quality among patients with fibromyalgia through 12 weeks, and adverse effects were consistent with the medication’s known safety profile, according to data published in Current Medical Research and Opinion.
“Pregabalin is a therapy approved for the treatment of [fibromyalgia (FM)-related] pain in multiple countries worldwide, and its efficacy for the treatment of FM-related pain has been demonstrated in several double-blind, randomized, placebo-controlled clinical trials,” Andrew Clair, PhD, and Birol Emir, PhD, both of Pfizer, in New York, wrote. “These clinical trials enrolled subjects with moderate or severe FM 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 FM-related pain by differences in baseline pain in severity categories (eg, moderate vs. severe).”
To analyze pregabalin’s efficacy for pain and sleep improvement through 12 weeks among patients with FM who have moderate-to-severe baseline pain, the researchers collected data from five randomized, double-blind, placebo-controlled phase 3 clinical trials. In these trials participants were adults aged 18 years or older with FM who had moderate pain, defined as a score of 4 to 6 on the 11-point numeric rating scale, or severe pain, with a score of 7 to 10. The treatment was 300 mg to 450 mg of pregabalin.
The pooled analysis included 1,605 participants treated with pregabalin and 929 individuals who were given a placebo. The analysis included mixed effects repeated measures, baseline observation carried forward, or logistic regression.
According to the researchers, all participants self-reported reduced pain and improved sleep quality from week 8 through week 12 (P < .01). In addition, greater improvements in pain and sleep quality were recorded among those who had baseline severe pain and were treated with the medication (P < .01). Treatments were well tolerated among participants, and adverse effects were in line, in both patients with severe and moderate baseline pain, with the results of previously published trials, the researchers said.
“Pregablin was found to be efficacious and generally well tolerated as a treatment for reducing pain in subjects with FM 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.” – by Jason Laday
Disclosure: Clair and Emir report that they are employees and shareholders of Pfizer, which sponsored the study.