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Title: Pregabalin Effective Across Clinically Relevant Subgroups in Generalized Anxiety Disorder: Presented at APA

"Pregabalin Effective Across Clinically Relevant Subgroups in Generalized Anxiety Disorder: Presented at APA"

By Bruce Sylvester NEW YORK, NY -- May 6, 2004 -- The investigative agent pregabalin is efficacious for generalized anxiety disorder (GAD) across clinically relevant subgroups, researchers reported here on May 3rd at the American Psychiatric Association Annual Meeting. "We often see patients with GAD also presenting with physical symptoms and sleep disturbances, along with the psychological distresses," said Mark Pollack, MD, director, Anxiety Disorders Program, Massachusetts General Hospital, and associate professor of psychiatry, Harvard Medical School, Boston, Massachusetts. "We looked at 5 significant studies of GAD, and they indicated that pregabalin significantly reduces psychological and somatic symptoms, along with sleep-disturbance symptoms." The investigators analyzed data from placebo-controlled phase 2 and phase 3 studies of pregabalin as treatment for GAD as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The team combined data on all dosage groups (200 to 600 mg/day) to get the analysis cohort total of 1,282 subjects. Sixty percent of the subjects were female, with a mean age of 39.4 yrs and a baseline Hamilton- A score (HAM-A) of 25.4. Subgroups included those defined by gender, age, severity (HAM-A >/= 26), subsyndromic depression (HAM-D >/= 15), severe somatic symptoms (HAM-A somatic factor >/= 12), and severe insomnia. The investigators did a Week 4/6 analysis, defining responders as those achieving >/= 50% reduction in HAM-A total score. The researchers found that pregabalin achieved significantly greater improvement in symptoms as demonstrated by a decrease of 12.7 points compared with 9.3 points for placebo, and significant improvement appeared as early as the first week. Significantly more subjects with moderate or severe anxiety, severe physical symptoms, or prominent insomnia (56%, 51%, 57%, and 56%, respectively) achieved a 50% or greater reduction in symptoms, compared to placebo (34%, 36%, 35%, and 35% reductions, respectively). The investigators also reported improvements in the HAM-A Psychic and Somatic Factor Score in the pregabalin-treated patients, with a 6.8-point psychic-score reduction (in excessive anxiety, worry, and tension) for pregabalin versus a 4.9 point reduction for placebo (P < 0.001), and improvements in somatic symptoms, with a 5.9-point reduction (in aches and pains, pressure in chest, dyspnea, abdominal distress) for pregabalin versus a 4.4-point reduction for placebo (P < 0.001). "These findings suggest that this promising new agent may be quite powerful in its therapeutic reach among a broad range of GAD patients," Dr. Pollack added. The authors noted that somnolence and dizziness were the most frequently reported side effects in the pregabalin groups, with most cases being resolved during trial and without early withdrawal. Pregabalin is currently under review by the U.S. Food and Drug Administration for the management of generalized anxiety disorder, neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (post-herpetic neuralgia), and as adjunctive therapy in the treatment of partial seizures in adults. This research was supported by Pfizer Inc. [Presentation title: Pregabalin in GAD: Efficacy in Clinically-Relevant Subtypes. Abstract NR224]

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