Disclosures: Drs. Hauser, Lew, Hurtig, Ondo, and Wojcieszek's institutions received compensation from Teva Pharmaceuticals, Inc. and Teva Neuroscience, Inc. for their sites' conduct of the study. Drs. Hauser, Lew, Wojcieszek, and Ondo have received honoraria and consulting fees from Teva Pharmaceutical Industries, Inc. and/or Teva Neuroscience, Inc. Dr. Fitzer-Attas is an employee of Teva Pharmaceutical Industries, Ltd.
Article first published online: 11 DEC 2008
Copyright © 2008 Movement Disorder Society
Volume 24, Issue 4, pages 564–573, 15 March 2009
How to Cite
Hauser, R. A., Lew, M. F., Hurtig, H. I., Ondo, W. G., Wojcieszek, J. and Fitzer-Attas, C. J. (2009), Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. Mov. Disord., 24: 564–573. doi: 10.1002/mds.22402
Non-sponsor disclosures: Dr. Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai Ltd, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KgaA, Novartis, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant, and Vernalis. Dr Lew has received honoraria or consulting fees from Boehringer-Ingelheim, GSK, Allergan, Solstice, Novartis, Teva, Valeant, UCB, Bayer, BI, Kyowa,Schwarz Pharma,Ipsen, Prestwick, Vernalis. He has received research funding from Teva, BI, GSK, Kyowa, Solstice, Novartis, Schwarz Pharma/UCB, Ipsen, NIH, Eisai, Mentor, Solvay, Schering Plough. Dr. Wojcieszek has received honoraria from Schwartz Pharma and Valeant. Dr. Ondo has received honoraria or consulting fees from Bayer Schering Pharma AG, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Prestwick, UCB Pharma, Solvay, Teva Neuroscience, Valeant, Allergan, and Vernalis.
Members of “TEMPO Open-label Study Group” are listed as an Appendix.
- Issue published online: 24 MAR 2009
- Article first published online: 11 DEC 2008
- Manuscript Accepted: 24 OCT 2008
- Manuscript Revised: 5 OCT 2008
- Manuscript Received: 27 APR 2008
- Teva Pharmaceutical Industries, Ltd.
- Teva Neuroscience, Inc. (USA)
- H. Lundbeck A/S
- Parkinson's disease;
- disease modification;
- MAO-B inhibitor
The purpose of this study to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was significant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society