Pregabalin reduced pain and improved quality of sleep among fibromyalgia sufferers and improving sleep quality among patients with fibromyalgia, 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,” said Andrew Clair, PhD, and Birol Emir, PhD, in a press release.
“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 (e.g., moderate vs. severe),” they added.
The researchers collected data from five randomized, double-blind, placebo-controlled phase 3 clinical trials to determine efficacy through 12 weeks. Adults in the trials were diagnosed with FM and had either moderate pain (4-6 on 11 point rating scale) or severe pain (7-10), and were treated with 300 mg to 450 mg of pregabalin.
A total of 1,605 participants were treated with pregabalin and 929 were given placebo. All participants taking the drug self-reported a reduction in pain and improvement in sleep quality from week 8 through week 12 (P < .01). There was greater improvement in both pain and sleep quality for those whose baseline was severe and were treated with the medication (p < .01).
“Pregabalin 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.”