Efficacy and Tolerability of Paroxetine for the Long-Term Treatment of Generalized Anxiety Disorder
J Clin Psychiatry 2003;64:250-258
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Paroxetine has demonstrated efficacy
in depression and anxiety disorders, including generalized
anxiety disorder (GAD). This 32-week study evaluated the
maintained efficacy and safety of paroxetine in GAD by assessing
the potential for relapse after discontinuation of medication.
Method: Adults (N = 652) with DSM-IV GAD and a
Clinical Global Impressions-Severity of Illness (CGI-S) score
>= 4 received paroxetine (20-50 mg/day) for 8 weeks. Patients
whose CGI-S score had decreased by at least 2 points to <= 3
at week 8 were randomly assigned to double-blind treatment with
paroxetine (N = 278) or placebo (N = 288) for a further 24 weeks.
The primary efficacy parameter was the proportion of patients
relapsing (an increase in CGI-S score of at least 2 points to a
score >= 4 or withdrawal resulting from lack of efficacy)
during double-blind treatment.
Results: Significantly fewer paroxetine than
placebo patients relapsed during the 24-week double-blind phase
(10.9% vs. 39.9%; p < .001). Placebo patients were almost 5
times more likely to relapse than paroxetine patients (estimated
hazard ratio = 0.213 [95% CI = 0.1 to 0.3]; p < .001).
Statistical significance in favor of paroxetine was demonstrated
for all secondary efficacy parameters, including functional
status. Twice as many paroxetine patients as placebo patients
(73%) achieved remission. Paroxetine was well tolerated, with no
unexpected adverse events reported.
Conclusion: Paroxetine was found to be effective
and well tolerated for both the short- and long-term treatment of
DSM-IV GAD. Continued treatment with paroxetine significantly
reduced the potential for relapse of GAD symptoms.