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October 30, 2002
NEW ORLEANS, Oct. 25 /PRNewswire-FirstCall/ -- Pfizer Inc's pregabalin was
shown to provide improvement of pain in patients with fibromyalgia, a chronic
and debilitating pain syndrome, according to data presented here today at the
annual meeting of the American College of Rheumatology.
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.
The double-blind, placebo-controlled monotherapy study involved
529 patients diagnosed with FMS. Patients were randomized to receive placebo
or pregabalin (150 mg, 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 (450 mg/day) showed statistically significant
improvements in pain compared to those who received placebo. Further,
29 percent of pregabalin-treated patients reported at least a 50 percent
reduction in pain, compared with a reduction of 13 percent for 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 treatments for this condition," said Dr. Leslie Crofford, lead
investigator and associate professor of internal medicine, Division of
Rheumatology, at the University of Michigan in Ann Arbor.
"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," Dr. Crofford said. "These data are highly encouraging because
pregabalin was shown to provide significant relief from the most troublesome
symptoms for patients."
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 filing of a New Drug Application for pregabalin
for the treatment of neuropathic pain and generalized anxiety disorder and as
an add-on therapy for epilepsy.
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