(11/10/02 7:31 pm)
Pregabalin Effective in Treating Symptoms of Fibromyalgia|
Pregabalin Effective in Treating Symptoms of Fibromyalgia
By Emma Hitt
Special to DG News
NEW ORLEANS, LA -- October 30, 2002-- Pregabalin appears to prevent symptoms and improve quality of life and sleep disturbances in patients with fibromyalgia, new trial findings suggest.
These findings were presented at the American College of Rheumatology (ACR) 66th Annual Scientific Meeting.
Pregabalin (Pfizer Inc.) is structurally related to gamma amino butyric acid (GABA); however, it binds to calcium channels, not GABA receptors, and modulates calcium influx, resulting in analgesic, anxiolytic and anticonvulsant activity.
Dr. Leslie Crofford, with the University of Michigan, Ann Arbor, United States, and colleagues evaluated the efficacy and safety of pregabalin up to 450mg/day (150 mg TID) for reducing pain and associated symptoms in 529 patients with fibromyalgia.
Patients were randomized to receive 150, 300 or 450mg/day of pregabalin or placebo for eight weeks.
Those taking pregabalin 450mg/day showed a significantly improved mean pain score compared to those receiving placebo (-0.93; p<0.001), and they were more likely to experience a 50 percent reduction in pain from baseline (p =.003), the researchers found.
Furthermore, compared to those taking 150 mg/day pregabalin or placebo, patients receiving 300 or 450mg/day pregabalin also experienced less fatigue and improved sleep quality.
Forty eight patients (9 percent) withdrew due to adverse events, the most common being dizziness and somnolence; 44 patients (8 percent) withdrew due to lack of efficacy.
According to Dr. Crofford, treatments for fibromyalgia are limited, and pregabalin represents another treatment option compared to tricyclic antidepressants and serotonin reuptake inhibitors, she told Doctor's Guide.
The study was funded by Pfizer Inc. The company will be filing an application for approval for neuropathic pain and anxiety indications in the US and in Europe this year, Dr. Crofford said.