Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended ReleaseReportar como inadecuado




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Parkinson-s Disease - Volume 2014 2014, Article ID 467131, 8 pages -

Clinical Study

University of South Florida, Parkinson’s Disease and Movement Disorders Center, Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL 33613, USA

Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA

Department of Neurology, Juntendo University School of Medicine, Tokyo 113-8421, Japan

Department of Neurology, Innsbruck Medical University, Innsbruck, Austria

Center for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, Italy

Department of Clinical Neurosciences, University College London Institute of Neurology, London, UK

Clinical Investigation Center, INSERM CIC-9302 and UMR-825 and Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, Toulouse, France

Boehringer Ingelheim France S.A.S., Reims, France

Boehringer Ingelheim Pharmaceuticals, GmbH & Co. KG, Ingelheim, Germany

Received 31 October 2013; Accepted 28 January 2014; Published 1 April 2014

Academic Editor: Francisco Grandas

Copyright © 2014 Robert A. Hauser 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

Background. The minimal clinically important difference MCID is the smallest change in an outcome measure that is meaningful for patients. Objectives. To calculate the MCID for Unified Parkinson’s Disease Rating Scale UPDRS scores in early Parkinson’s disease EPD and for UPDRS scores and “OFF” time in advanced Parkinson’s disease APD. Methods. We analyzed data from two pivotal, double-blind, parallel-group trials of pramipexole ER that included pramipexole immediate release IR as an active comparator. We calculated MCID as the mean change in subjects who received active treatment and rated themselves “a little better” on patient global impression of improvement PGI-I minus the mean change in subjects who received placebo and rated themselves unchanged. Results. MCIDs in EPD pramipexole ER, pramipexole IR for UPDRS II were −1.8 and −2.0, for UPDRS III −6.2 and −6.1, and for UPDRS II + III −8.0 and −8.1. MCIDs in APD for UPDRS II were −1.8 and −2.3, for UPDRS III −5.2 and −6.5, and for UPDRS II + III −7.1 and −8.8. MCID for “OFF” time pramipexole ER, pramipexole IR was −1.0 and −1.3 hours. Conclusions. A range of MCIDs is emerging in the PD literature that provides the basis for power calculations and interpretation of clinical trials.





Autor: Robert A. Hauser, Mark Forrest Gordon, Yoshikuni Mizuno, Werner Poewe, Paolo Barone, Anthony H. Schapira, Olivier Rascol, C

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



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