Note: On June 21, 2007, Lyrica (pregabalin capsules CV) were approved by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia.
Lyrica for Fibromyalgia
According to a study published in the April 2005 issue of Arthritis & Rheumatism, the medication Lyrica (generic name pregabalin):
- significantly reduced the pain of fibromyalgia syndrome
- improved sleep and fatigue
- improved other patient-reported conditions including bodily pain and vitality
Fibromyalgia is characterized by widespread pain, fatigue, and sleep problems. Fibromyalgia is difficult to treat. The cause is unknown and there is no approved treatment which eliminates or controls the primary symptoms of fibromyalgia.
Lyrica for Fibromyalgia Study
In the study, which was an eight-week double-blind trial led by a University of Kentucky physician, 529 fibromyalgia patients were randomized to receive one of three daily doses of Lyrica (150, 300, or 450 mgs.) or placebo. The primary objective of the study was reduction in severity of pain.
Statistics about the study participants reveal that, on average, patients were women in their late 40s who had long histories (average duration nine years) with fibromyalgia. The study participants had moderate to severe pain and diminished quality of life.
Prior to the onset of the trial, study participants discontinued all medications for pain and sleep except acetaminophen, aspirin, or symptomatic migraine treatment.
Lyrica for Fibromyalgia Study Results
The benefit of Lyrica for fibromyalgia was demonstrated as early as the first week of treatment.
A significantly greater proportion of patients receiving Lyrica versus placebo (48% vs. 27%) experienced a clinically meaningful reduction in pain. What defines a clinically meaningful reduction in pain? It is defined as a 30% or greater improvement in pain.
Significantly more patients taking 450 mg per day Lyrica experienced a 50% or greater reduction in pain at the end of the study compared with placebo, (29% vs. 13%).
Using daily sleep diaries and a sleep scale measurement, patients taking Lyrica reported significant improvement in sleep compared to those receiving placebo. Patients taking Lyrica also reported reduced fatigue on a scale of severity, distress, degree of interference in activities of daily living, and timing.
Mild-to-moderate dizziness and sleepiness were reported as the two most common side effects by patients given Lyrica. The side effects appeared to be dose related.
Lyrica Already Approved For Other Indications
In December 2004, The U.S. Food and Drug Administration approved Lyrica for the management of two of the most common forms of nerve pain, diabetic peripheral neuropathy and post-herpetic neuralgia.
Related Resources
Source: Pregabalin for the Treatment of Fibromyalgia Syndrome, Arthritis & Rheumatism, April 2005
