Patients taking Lyrica reported significant improvement in the quality of sleep compared to those who received placebo, as assessed by daily sleep diaries and a sleep scale measurement. Additionally, patients taking Lyrica reported reduced fatigue on a scale of severity, distress, degree of interference in activities of daily living, and timing.
In this eight-week double-blind trial, 529 patients with fibromyalgia were randomized to receive one of three daily doses of Lyrica (150 mg, 300 mg, or 450 mg) or placebo. The primary objective was reduction in the severity of pain. Pain scores were recorded in daily diaries. On average, patients in the study were women in their late 40s who had a long history of fibromyalgia, with average duration nine years, and had experienced moderate to severe pain and diminished quality of life. Prior to the trial, study participants discontinued all medications for pain and sleep disorders except for acetaminophen, aspirin or symptomatic migraine treatment.
The two most common side effects reported by Lyrica-treated patients were mild-to-moderate dizziness and sleepiness, and tended to be dose-related. Few patients discontinued the trial due to these side effects. About 80 percent of patients from all treatment groups entered the open-label extension.
The U.S. Food and Drug Administration (FDA) approved Lyrica in December 2004 for the management of two of the most common forms of neuropathic (nerve) pain, diabetic peripheral neuropathy and post herpetic neuralgia. Lyrica will be available in pharmacies in the future. Lyrica is currently under review by the FDA for the adjunctive treatment of partial seizures in adults.
Pfizer's Lyrica is currently available in various European Union member states for the treatment of peripheral neuropathic pain and as adjunctive therapy for partial seizures, and in Mexico f
Contact: Amanda W. Nelson
University of Kentucky