A drug called pregabalin has been shown to be an effective and safe treatment for pain in patients with fibromyalgia, according to study data being presented at the annual meeting of the American College of Rheumatology. The drug, Pregabalin, also was shown to improve sleep and fatigue levels, the data demonstrate. Fibromyalgia syndrome (FMS) is a chronic disorder characterized by widespread musculoskeletal pain that is frequently associated with fatigue and sleep disturbances. It is estimated to affect two percent of the population, or 5.6 million Americans, and occurs most frequently in women. From the University of Michigan Health System:Drug significantly improves pain in fibromyalgia patients, new data show
No therapies approved for chronic pain associated with fibromyalgia Poor sleep and fatigue also characterize condition
NEW ORLEANS – A drug called pregabalin has been shown to be an effective and safe treatment for pain in patients with fibromyalgia, according to study data being presented at the annual meeting of the American College of Rheumatology by a University of Michigan Health System researcher.
Pregabalin, a product of Pfizer Inc., also was shown to improve sleep and fatigue levels, the data demonstrate.
Fibromyalgia syndrome (FMS) is a chronic disorder characterized by widespread musculoskeletal pain that is frequently associated with fatigue and sleep disturbances. It is estimated to affect two percent of the population, or 5.6 million Americans, and occurs most frequently in women.
The double-blind, placebo-controlled monotherapy study involved 529 patients diagnosed with FMS. Patients were randomized to receive placebo or pregabalin at doses of 150 milligrams, 300 mg or 450 mg per day for eight weeks. The study evaluated the efficacy and safety of pregabalin for the treatment of pain and associated symptoms such as sleep and fatigue. Patients were required to characterize and record their pain on a daily basis in detailed diaries.
Pregabalin treated patients who received the 450 mg/day dose showed statistically significant improvements in pain compared to those who received placebo. Further, 29 percent of pregablin-treated patients reported at least a 50 percent reduction in pain, compared with 13 percent of patients who received placebo, a difference that was statistically significant. In addition, pregabalin significantly improved sleep quality and fatigue.
“To demonstrate improvements in the core symptoms of FMS – pain, sleep and fatigue – represents an important advance, particularly as there are no approved treatment for this condition,” says Leslie Crofford, M.D., the study’s lead investigator and associate professor of internal medicine, Division of Rheumatology, at the University of Michigan Medical School.
“FMS is highly debilitating for patients and difficult to treat, and we are in need of new treatment options that are both effective and well tolerated,” Crofford explains. “These data are highly encouraging because pregabalin was shown to provide significant relief from the most troublesome symptoms for patients.”
Crofford notes that the study represents a collaboration between the University of Michigan and Pfizer’s Ann Arbor, MI research and development center.
The most common dose-related side effects reported by patients were dizziness and drowsiness. Most adverse events were mild to moderate in intensity and many resolved during the study. Seventy-eight percent of all patients completed the study.
Developed by Pfizer, pregabalin has been studied in an extensive clinical program involving over 8,000 patients worldwide. The company has completed pivotal studies to support the approval of pregabalin for the treatment of neuropathic pain and generalized anxiety disorder and as an add-on therapy for epilepsy.
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