Pomaglumetad Methionil LY2140023 Monohydrate and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind ComparisonReportar como inadecuado




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Schizophrenia Research and Treatment - Volume 2014 2014, Article ID 758212, 11 pages -

Clinical StudyLilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA

Received 16 October 2013; Revised 31 January 2014; Accepted 4 February 2014; Published 19 March 2014

Academic Editor: Robin Emsley

Copyright © 2014 David H. Adams et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil or aripiprazole . Treatment groups were also compared on efficacy and various safety measures, including serious adverse events SAEs, discontinuation due to adverse events AEs, treatment-emergent adverse events TEAEs, extrapyramidal symptoms EPS, and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 Visit 12 compared with the aripiprazole group −2.8 ± 0.4 versus 0.4 ± 0.6; . However, change in Positive and Negative Syndrome Scale PANSS total scores for aripiprazole was significantly greater than for pomaglumetad methionil −15.58 ± 1.58 versus −12.03 ± 0.99; . The incidences of SAEs 8.2% versus 3.1%; and discontinuation due to AEs 16.2% versus 8.7%; were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.gov NCT01328093.





Autor: David H. Adams, Lu Zhang, Brian A. Millen, Bruce J. Kinon, and Juan-Carlos Gomez

Fuente: https://www.hindawi.com/



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