Drug that reduces the pain of fibromyalgia and improves sleep

Apr 12 2005

A study of a drug that reduces the pain of fibromyalgia and improves sleep is published by a University of Kentucky physician in the peer-reviewed journal, Arthritis & Rheumatism.

The lead author of the study was Dr. Leslie Crofford, professor, UK College of Medicine, chief, Division of Rheumatology, and the Gloria W. Singletary Chair and Director of the Center for the Advancement of Women's Health.

"Fibromyalgia is a debilitating condition affecting as many as six million Americans, yet there is no approved treatment that relieves its core symptoms," said Crofford. "This is the first prospective study suggesting that Lyrica may be effective in improving the pain of fibromyalgia and some of its other symptoms such as sleep problems and fatigue."

Pfizer Inc's Lyrica (pregabalin) significantly reduced the pain of fibromyalgia and improved sleep, fatigue and other patient-reported conditions such as bodily pain and vitality, according to a study published in Arthritis & Rheumatism.

Fibromyalgia is characterized by widespread musculoskeletal pain, fatigue and sleep problems. Fibromyalgia is difficult to treat, with most patients continuing to have persistent symptoms even after pain management interventions. The cause of fibromyalgia is unknown. In the study, patients treated with Lyrica experienced a greater reduction in pain compared to those who received placebo.

The benefit with Lyrica was demonstrated as early as the first week of treatment. In addition, a significantly greater proportion of patients receiving Lyrica versus placebo (48 percent versus 27 percent) experienced a clinically meaningful reduction of pain, as defined by a 30 percent or greater improvement in pain. Additionally, significantly more patients taking Lyrica (450 mg per day) experienced a 50 percent or greater reduction in pain at the end of the study compared with placebo (29 percent versus 13 percent, respectively).

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.

Study Background

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.

LYRICA Background

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 for the treatment of neuropathic pain and as adjunctive therapy for partial seizures.