Health-related quality of life (HRQOL) among patients with Generalised Anxiety Disorder: evaluation conducted alongside an escitalopram relapse prevention trial

Background: Improving health-related quality of life (HRQoL) should be a treatment goal for patients with Generalised Anxiety Disorder (GAD). Objectives: To assess the impact of treatment with escitalopram on HRQoL as well as the effect of relapse on HRQoL and work productivity. Methods: This study was conducted alongside a double-blind, placebo-controlled, relapse prevention multinational clinical trial. Relapse was defined as a Hamilton Anxiety Scale (HAMA) >= 15. Treatment responders (HAMA <= 10) after 12 weeks of open-label treatment (10 mg/day escitalopram for Week 1 followed by 20 mg/day thereafter) were included. The study dataset comprised patients (n = 329) from French, Canadian, German and Swedish centres. HRQoL was assessed using the SF-36 scale, and data on sick leave and on-the-job productivity as measured by the Work Limitation Questionnaire and the work efficacy and work satisfaction visual analogue scales (VAS) scales were collected at baseline, randomization (Week 12), Weeks 36, 60 and at last assessment. For future health economic analysis, quality adjusted life years were calculated from the SF-36 results. Results: At baseline, GAD patients reported significantly impaired quality of life compared with the general population. During the 12-week open-label treatment period, treatment responders reported significant improvements in HRQoL on all dimensions of the SF-36 (p < 0.001) and on-the-job productivity (p < 0.001), whereas sick leave decreased but did not reach statistical significance. After randomization, relapsed patients reported significantly lower QoL than non-relapsed patients on all 4 SF-36 mental health dimensions (p < 0.001). Relapsed patients reported slightly lower on-the-job productivity than non-relapsed patients and scored lower on the work efficacy and work satisfaction VAS scales. Conclusion: GAD adversely affects patient functioning and daily life. Short-term treatment with escitalopram reverses this impairment to population norms. GAD relapse is associated with a deterioration of HRQoL and work productivity.