P0100 - Influence of gender on the clinical presentation of generalized anxiety disorder, and response to treatment with Pregabalin

Abstract

Background and Aims:

To assess gender differences in the clinical presentation of GAD and response to pregabalin (PGB) treatment.

Methods:

Data were pooled from 6 randomized, double-blind, placebo-controlled, 4- to 6-week trials of outpatients who met DSM-IV criteria for GAD with a minimum HAM-A total score >18. Response was evaluated for 3 fixed-dosage groups: 150 mg/d, 300-450 mg/d, and 600 mg/d.

Results:

Baseline presentation of GAD was similar for women and men, respectively, for mean (±SD) age (38.6±12.3 vs 39.4±11.5 y) and severity of concurrent depressive symptoms (HAM-D score, 13.7±4.4 vs 13.4±4.3). However, women had a modest but significantly higher mean HAM-A somatic factor score (11.5±3.2 vs 10.8±3.1; P<0.01). For both sexes, treatment with PGB resulted in significantly higher LOCF-endpoint improvement in HAM-A total score: Women: PGB-150 mg, -10.7±0.82; PGB-300/450 mg, -11.8±0.68; PGB-600 mg, -12.4±0.59 vs. placebo, -9.5±0.51; P<0.0001 for all comparisons; Men: PGB-150 mg, -10.8±0.81; PGB-300/450 mg, -12.6±0.59; PGB-600 mg, -11.6±0.51 vs placebo, -8.7±0.47; P<0.0001 for all comparisons. CGI-I responder rates were significantly higher (P<0.001) on PGB (combined doses) vs. placebo for both women (50% vs 35%) and men (53% vs 38%). There were no gender differences in attrition due to adverse events, or in proportion of severe adverse events.

Conclusion:

Women and men with GAD showed similar clinical presentations, with women reporting somewhat more somatic symptoms. Pregabalin was an effective and well-tolerated treatment for GAD for both sexes.

Funded by Pfizer Inc