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Paroxetine beats placebo for reducing symptoms of anxiety. (Panic, Generalized or Social Anxiety).

YOKOHAMA, JAPAN -- Paroxetine is more effective than placebo in helping patients with panic disorder, generalized anxiety disorder, or social anxiety disorder achieve remission, according to three separate analyses that were based on data from multiple randomized, double-blind, placebo-controlled trials.

The results of the analyses were presented in poster presentations at the 12th World Congress of Psychiatry GlaxoSmithKline, which makes paroxetine (Paxil), funded the analyses as well as the studies upon which they were based.

All three analyses used remission as the criterion for success, rather than the more traditional, less rigorous measures of treatment response, which typically look for a 50% or greater reduction in symptoms as a sign of efficacy.

In the analysis of treatment of patients with panic disorder, four short-term studies randomized 966 patients to paroxetine or placebo or--in two of the studies--the tricyclic antidepressant clomipramine (Anafranil) or the benzodiazepine aiprazolam (Xanax) for 10 or 12 weeks.

Two of the trials evolved into long-term extension studies involving 269 patients, some of whom continued therapy for 9 additional months while others continued therapy for 12 weeks and then were randomized to the same treatment or placebo for 12 additional weeks of maintenance therapy.

At the end of the short-term trials, the proportion of patients who reported no panic attacks in the previous 2-3 weeks reached 44% on alprazolam, 35% on paroxetine, and 27% on clomipramine, rates that were significantly higher than the 22% remission rate on placebo.

In one of the long-term trials, 68% of patients maintained on paroxetine and 48% taking placebo reported no panic attacks. In the other long-term trial, 72% of patients on paroxetine, 64% on clomipramine, and 33% on placebo reported no panic attacks, said Dr. Yves Lecrubier of Salpetiere Hospital, Paris.

The results were similar when two other measures of remission--a Clinical Global Impression (CGI) score of 1 ("very much improved") or a Sheehan Disability Scale (SDS) score of less than 5--were used. Alprazolam, paroxetine, and clomipramine worked significantly better than placebo in the short-term trials, and in the long-term studies, paroxetine and clomipramine worked better than placebo to induce remission.

Data from one of the long-term studies allowed investigators to combine all three measures for an even more rigorous definition of remission: no panic attacks, a CGI score of 1, and an SDS score of less than 5. In this analysis, 57% percent of the paroxetine group and 27% of the placebo group achieved remission as defined by this standard.

The analysis of treatment of patients with generalized anxiety disorder (GAD) included data from three 8-week studies involving 1,264 patients and one long-term study of 561 patients who responded to 8 weeks of paroxetine therapy and then were randomized to paroxetine or placebo for 24 more weeks.

All of the studies compared paroxetine with placebo. GAD Patients who recieved paroxetine were two to five times as likely as those who received placebo to meet one of three definitions of remission--a Hamilton Rating Scale for Anxiety score of 7 or less, a CGI score of 1, or an SDS score of less than 5, reported Dr. Karl Rickels of the University of Pennsylvania, Philadelphia.

When all three of the remission criteria were combined, 46% of the GAD patients who were maintained on paroxetine in the long-term trial and 18% of those on placebo were considered to be in remission.

The analysis of treatment for social anxiety disorder used data on 825 patients in three 12-week studies and one long-term study of 323 patients who responded to 12 weeks of paroxetine therapy and then were randomized to paroxetine or placebo for an additional 24 weeks.

Patients who received paroxetine were two to four times as likely as patients who received placebo to meet one of three definitions of remission--a 70% or greater reduction in Liebowitz Social Anxiety Scale scores, a CGI score of 1, or an SDS score of less than 5, reported Dr. D.J. Stein of the University of Stellenbosch, Matieland, South Africa.

When all three of the remission criteria were combined, 45% of the patients on paroxetine in the long-term trial and 26% of those on placebo achieved remission.
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Author:Boschert, Sherry
Publication:Internal Medicine News
Date:Dec 15, 2002
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