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

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.

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.

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