Display options
Cite
Hauser RA, Gordon MF, Mizuno Y, et al. Minimal clinically important difference in Parkinson's disease as assessed in pivotal trials of pramipexole extended release. Parkinsons Dis. 2014;2014:467131doi: 10.1155/2014/467131.
Hauser, R. A., Gordon, M. F., Mizuno, Y., Poewe, W., Barone, P., Schapira, A. H., Rascol, O., Debieuvre, C., & Fräßdorf, M. (2014). Minimal clinically important difference in Parkinson's disease as assessed in pivotal trials of pramipexole extended release. Parkinson's disease, 2014467131. https://doi.org/10.1155/2014/467131
Hauser, Robert A, et al. "Minimal clinically important difference in Parkinson's disease as assessed in pivotal trials of pramipexole extended release." Parkinson's disease vol. 2014 (2014): 467131. doi: https://doi.org/10.1155/2014/467131
Hauser RA, Gordon MF, Mizuno Y, Poewe W, Barone P, Schapira AH, Rascol O, Debieuvre C, Fräßdorf M. Minimal clinically important difference in Parkinson's disease as assessed in pivotal trials of pramipexole extended release. Parkinsons Dis. 2014;2014:467131. doi: 10.1155/2014/467131. Epub 2014 Apr 01. PMID: 24800101; PMCID: PMC3995302.
Copy Download .nbib Format: NLM
Share it on

Parkinsons Dis. 2014;2014:467131. doi: 10.1155/2014/467131. Epub 2014 Apr 01.

Minimal clinically important difference in Parkinson's disease as assessed in pivotal trials of pramipexole extended release.

Parkinson's disease

Robert A Hauser, Mark Forrest Gordon, Yoshikuni Mizuno, Werner Poewe, Paolo Barone, Anthony H Schapira, Olivier Rascol, Catherine Debieuvre, Mandy Fräßdorf

Affiliations

  1. University of South Florida, Parkinson's Disease and Movement Disorders Center, Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL 33613, USA.
  2. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA.
  3. Department of Neurology, Juntendo University School of Medicine, Tokyo 113-8421, Japan.
  4. Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.
  5. Center for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, Italy.
  6. Department of Clinical Neurosciences, University College London Institute of Neurology, London, UK.
  7. Clinical Investigation Center, INSERM CIC-9302 and UMR-825 and Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, Toulouse, France.
  8. Boehringer Ingelheim France S.A.S., Reims, France.
  9. Boehringer Ingelheim Pharmaceuticals, GmbH & Co. KG, Ingelheim, Germany.

PMID: 24800101 PMCID: PMC3995302 DOI: 10.1155/2014/467131

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.

References

  1. Arch Neurol. 2002 Dec;59(12):1937-43 - PubMed
  2. Mov Disord. 2003 Jul;18(7):738-50 - PubMed
  3. Arch Neurol. 2010 Jan;67(1):64-70 - PubMed
  4. Mov Disord. 2006 Aug;21(8):1200-7 - PubMed
  5. Neurology. 2011 Aug 23;77(8):759-66 - PubMed
  6. Mov Disord. 2010 Nov 15;25(15):2542-9 - PubMed
  7. Mov Disord. 2006 Aug;21(8):1059-61 - PubMed
  8. Health Qual Life Outcomes. 2006 Oct 11;4:79 - PubMed
  9. Rev Neurol Dis. 2007 Spring;4(2):75-84 - PubMed
  10. Mov Disord. 2011 Apr;26(5):813-8 - PubMed
  11. Neurology. 2011 Aug 23;77(8):767-74 - PubMed

Publication Types