Early improvement with pregabalin predicts endpoint response in patients with generalized anxiety disorder: an integrated and predictive data analysis. (January 2017)

• Record Type: Journal Article
• Authors: Montgomery, Stuart A.; Lyndon, Gavin; Almas, Mary; Whalen, Ed; Prieto, Rita
• Is Part Of: International clinical psychopharmacology. Volume 32:Number 1(2017:Jan.)
• Publication Date: 2017-01
• Subjects: generalized anxiety disorder -- predictive modelling -- pregabalin -- psychic -- somatic; Psychopharmacology -- Periodicals; Psychotropic drugs -- Periodicals; Psychopharmacology -- periodicals; Psychotropic Drugs -- periodicals; 615.7805
• DOI: 10.1097/YIC.0000000000000144
• Languages: English
• ISSNs: 0268-1315

Abstract

Abstract : Generalized anxiety disorder (GAD), a common mental disorder, has several treatment options including pregabalin. Not all patients respond to treatment; quickly determining which patients will respond is an important treatment goal. Patient-level data were pooled from nine phase II and III randomized, double-blind, short-term, placebo-controlled trials of pregabalin for the treatment of GAD. Efficacy outcomes included the change from baseline in the Hamilton Anxiety Scale (HAM-A) total score and psychic and somatic subscales. Predictive modelling assessed baseline characteristics and early clinical responses to determine those predictive of clinical improvement at endpoint. A total of 2155 patients were included in the analysis (1447 pregabalin, 708 placebo). Pregabalin significantly improved the HAM-A total score compared with the placebo at endpoint, treatment difference (95% confidence interval), −2.61 (−3.21 to −2.01), P <0.0001. Pregabalin significantly improved HAM-A psychic and somatic scores compared with placebo, −1.52 (−1.85 to −1.18), P <0.0001, and −1.10 (−1.41 to −0.80), P <0.0001, respectively. Response to pregabalin in the first 1–2 weeks (≥20 or ≥30% improvement in HAM-A total, psychic or somatic score) was predictive of an endpoint greater than or equal to 50% improvement in the HAM-A total score. Pregabalin is an effective treatment option for patients with GAD. Patients with early response to pregabalin are more likely to respond significantly at endpoint.