Rotigotine transdermal patch in combination therapy for Parkinson’s disease – observations in routine clinical practice

Abstract

Objective:

The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson’s disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice.

Methods:

Data were collected by 688 German practice-based neurologists, initiating rotigotine treatment in patients with idiopathic Parkinson’s disease. Assessments included rotigotine maintenance dose, changes in concomitant PD medication, changes in sleep quality, and rotigotine tolerability over an observation period of 12–16 weeks.

Results:

The median rotigotine maintenance dose was 6 mg/24 h (n = 969, full analysis set). The proportion of all other prescribed PD medications declined over the observation period; combination therapy decreased by 18.7%. Daily levodopa intake was markedly reduced by 87 mg (18.9%) in 47.6% of the patients with levodopa documentation; 7% no longer required levodopa after 12–16 weeks. Mean overall sleep quality (PD Sleep Scale item 1) improved by 21.4 points, the occurrence of nocturias (PDSS item 8) by 13.4 points, and ‘turning in bed’ (Unified Parkinson’s Disease Rating Scale part II) by 0.6 points. Drug-related adverse events were reported for 7.9% of all patients (n = 1152, safety population). Application site reactions were the most common adverse events (2.2%) resulting in early discontinuation in 1.4% of patients.

Conclusions:

In routine clinical practice, treatment initiation with rotigotine transdermal patch was associated with a reduction of other prescribed PD medications and with an improvement of self-reported sleep quality.

Key words::

• Combination therapy
• Dopamine agonist
• Levodopa dose reduction
• Parkinson’s disease
• Rotigotine transdermal patch
• Routine clinical practice
• Sleep quality

Transparency

Declaration of funding

UCB Pharma GmbH, Monheim, Germany provided funding for this analysis and for writing and editorial assistance in the preparation of this manuscript.

Declaration of financial/other relationships

H.-J.H. has disclosed that he is an employee of UCB Pharma. A.C.-B. has disclosed that he has received lecture fees and honoraria for consultancies from Allergan, Bayer Vital/Schering, Bristol-Myers-Squibb, Boehringer Ingelheim, Cephalon, Desitin, Eisai, Glaxo-Smith-Kline, Ipsen, Hofmann-LaRoche, Lilly, Lundbeck, Merz Pharmaceuticals, Medtronic, Novartis, Pfizer, Orion, Sanofi-Aventis, Teva, UCB/Schwarz Pharma, and Meda/Valeant. He also received research grants from Deutsche Forschungsgemeinschaft, Deutsche Parkinson Vereinigung e.V., Verein zur Förderung der Behandlung und Betreuung neurologisch Kranker e.V., Deutsche Stiftung Neurologie e.V, and Merz Pharmaceuticals.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgement

AFAP (Gesellschaft für angewandte Psychologie mbH, Cologne, Germany) carried out data management and statistical analysis; we thank Claudia Lewandowski for writing the results report. Further thanks go to E. Grosselindemann (Brett Medical Writing, Australia) and B. Brett (Brett Medical Writing, Germany) for writing and editorial assistance and publication coordination.

Previous presentation: poster presentation at the 82nd Conference of the German Neurological Society, September 23–26, 2009, Nuremberg, Germany.

Notes

*Neupro is a registered trademark of the UCB Group of Companies.