title: Early improvement with pregabalin predicts endpoint response in patients with generalized anxiety disorder: an integrated and predictive data analysis.
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.
authors: aDepartment of Psychiatry, Imperial College, London bPfizer Ltd, Tadworth, UK cPfizer Inc., New York, New York, USA dPfizer GEP SLU, Madrid, Spain.
authors: Stuart A
authors: SA
authors: Montgomery
authors: Gavin
authors: G
authors: Lyndon
authors: Mary
authors: M
authors: Almas
authors: Ed
authors: E
authors: Whalen
authors: Rita
authors: R
authors: Prieto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D000069583:Pregabalin / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D013223:Statistics as Topic / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D000069583:Pregabalin