The safety and efficacy of pregabalin in Generalized Anxiety Disorder (GAD) has been confirmed based on the results of 7 large, placebo-controlled trials. We report data on different patient populations from an open-label non-interventional observational trial under naturalistic conditions.

331 physicians (mainly psychiatrists) recruited 578 adult GAD patients and documented treatment with pregabalin over 4 weeks. GAD severity was rated by the patients using Hospital Anxiety and Depression Scale (HADS) and a 100mm daily Visual Analogue Scale (VAS-anxiety). Spontaneous Adverse Events (AEs) were collected.

Most patients received an initial dose of 150mg pregabalin per day, which was then increased to 300mg per day. Mean HADS-A Baseline Score (15.5 vs. 14.6) and Improvement (-5.9 vs. -6.1) was similar in younger (≤65 years, n=484) and older (>65 years, n=71) patients. Treatment naive patients had a lower HADS-A-Score (mean 14.2) than patients who got pregabalin add-on to their current medication (mean 15.8); both groups showed a similar improvement by 5.9 points over 4 weeks. A total of 26 AEs occured during this study, most of them rated mild to moderate in severity with no treatment related serious events. The pattern of events resembled the one known from clinical trials and post-marketing experience. 1.2% of subjects discontinued treatment due to adverse events.

Data from this non-interventional study in GAD show that pregabalin demonstrates similar effectiveness in adults and older (≤65 years) patients, regardless of whether used as mono- or adjunctive therapy.