Medline ® Abstracts for References 8-10
of 'Pharmacotherapy for generalized anxiety disorder'
Long-term pharmacological treatment of generalized anxiety disorder.
Mahe V, Balogh A
Int Clin Psychopharmacol. 2000;15(2):99.
Generalized anxiety disorder (GAD) is one of the most common anxiety disorders and has a poor prognosis, although it is often thought to be a minor complaint. This disorder has a chronic course of 5-15 years and longer. Long-term treatment with the commonly used benzodiazepines is controversial because of concerns over tolerance and dependence. We performed a thorough search of the literature for clinical trials of a duration of over 2 months conducted in patients with generalized anxiety disorder in order to identify any successful long-term treatment of this disorder. Only eight long-term reports of studies conducted in well-defined homogeneous groups of patients diagnosed with generalized anxiety disorder were found with the methodology of these studies presenting a number of limiting factors. The results are inconclusive and no reference drug could be identified. In addition, an adequate evaluation of the long-term treatment of GAD has not yet been performed.
Service de Psychiatrie, Hôpital Général de Meaux, France.
Paroxetine treatment of generalized anxiety disorder: a double-blind, placebo-controlled study.
Rickels K, Zaninelli R, McCafferty J, Bellew K, Iyengar M, Sheehan D
Am J Psychiatry. 2003;160(4):749.
OBJECTIVE: This study assessed the efficacy of two fixed doses of paroxetine in the treatment of generalized anxiety disorder.
METHOD: Outpatients (N=566) with generalized anxiety disorder and no other axis I disorder were eligible if they scored>/=20 on the Hamilton Rating Scale for Anxiety (with a score of 2 or higher on the anxious mood and tension items). Following a 1-week placebo run-in phase, patients were randomly assigned to 8 weeks of treatment with paroxetine, 20 or 40 mg/day, or placebo. The primary outcome measure was the change from baseline in total score on the Hamilton anxiety scale. Response was defined as a rating of "very much improved" or "much improved" on the Clinical Global Impression global improvement measure; remission was defined as a Hamilton anxiety scale score</=7. Change in functional impairment was measured with the Sheehan Disability Scale.
RESULTS: At 8 weeks, reductions in total score on the Hamilton anxiety scale were significantly greater for both paroxetine groups. Response was achieved by 62% and 68% of the patients receiving 20 and 40 mg of paroxetine, respectively, compared with a 46% response rate in the placebo group. Remission was achieved by 30% and 36% of patients in the 20- and 40-mg paroxetine groups, respectively, compared with 20% given placebo. For all three domains of the Sheehan Disability Scale, significantly greater improvement was seen with paroxetine than placebo. Both doses of paroxetine were well tolerated.
CONCLUSIONS: This study demonstrates that paroxetine is an efficacious and well-tolerated treatment for generalized anxiety disorder.
Department of Psychiatry, University of Pennsylvania Medical Center, Philadelphia 19104-3309, USA.
Efficacy and tolerability of paroxetine for the long-term treatment of generalized anxiety disorder.
Stocchi F, Nordera G, Jokinen RH, Lepola UM, Hewett K, Bryson H, Iyengar MK, Paroxetine Generalized Anxiety Disorder Study Team
J Clin Psychiatry. 2003;64(3):250.
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>or = 4 received paroxetine (20-50 mg/day) for 8 weeks. Patients whose CGI-S score had decreased by at least 2 points to<or = 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<or = 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.
Institute of Neurology, Istituto Ricerca Carattere Scientifico Neuromed, Pozzill Italy. firstname.lastname@example.org