Abstract
To analyze the effect of adjunctive therapy with pregabalin versus usual care (UC) on healthcare costs and clinical consequences in generalized anxiety disorder (GAD) patients with partial response (PR) to previous SSRI. Post-hoc analysis of patients enrolled in a prospective 6-month observational study. Patients with a PR [CGI score >3 and insufficient response with persistence of anxiety symptoms (HAM-A score ≥16)] to SSRI monotherapy were considered eligible for inclusion. Two groups (based on psychiatrist judgment) were analyzed 1) adding pregabalin (150-600 mg/day) to existing therapy; or 2) UC (switching to a different SSRI or adding another anxiolytic. Costs estimation used year-2009 prices for GAD related healthcare resources utilization. Measures of clinical consequences were, changes in total scores of anxiety in HAM-A (primary outcome) and GAD co-morbid depressive symptoms in MADRS (secondary outcome) scales. Four-hundred-eighty-six newly prescribed pregabalin and 239 UC GAD patients [mean (SD) HAM-A 26.7 (6.9) and CGI 4.1 (0.5)] were analyzed. Adding pregabalin was associated with significantly higher adjusted mean changes (95% CI) vs. UC in HAM-A [-11.2 (-12.2;-10.2) vs. -14.9 (-15.6;-14.2), respectively; p< 0.001] and MADRS [-7.8 (-8.7;-6.8) vs. -11.6 (- 12.2;-10.9), respectively; p< 0.001]. Adjusted mean baseline healthcare costs were significantly reduced in both cohorts; -€487 (-652;-317) and -€531 (-648;-413), respectively (both p< 0.001), yielding to similar 6-month costs; €1543 (1375;1711) UC and €1497 (1380;1614) pregabalin, p=0.661. In this post-hoc analysis, GAD patients with PR to SSRI experienced greater symptom improvement with adjunctive therapy with pregabalin versus UC without increasing healthcare cost.
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