Naturalistic evaluation of entacapone in patients with signs and symptoms of L-dopa wearing-off

ABSTRACT

Objective: To evaluate the effectiveness of entacapone in the management of levodopa wearing-off in Parkinson's disease (PD) in a naturalistic, real-life setting.

Research design and methods: This prospective, open-label, observational study included patients with idiopathic PD. Patients were eligible for inclusion if they had been taking 3–5 doses of levodopa per day for ≥2 months and had shown signs of levodopa wearing-off for ≥1 month. Subjects received entacapone (recommended dose: 1 × 200 mg tablet with each levodopa dose) for 28 days. Patients were asked to complete a wearing-off questionnaire and the eight-question Parkinson's Disease Questionnaire Quality of Life assessment (PDQ-8). Activities of daily living (both in the on and off states) were assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) part II. Clinical Global Impression (CGI) of severity of PD-related symptoms was assessed using a modified CGI tool. Patient global assessment of severity of PD symptoms was also obtained.

Results: A total of 341 patients were enrolled by 68 physicians across Canada. At Day 28, 56.9% of the subjects indicated improvement compared to baseline on the modified CGI of change (CGI-C); 21.4% reported no change. Improvements were also observed on the UPDRS II and the PDQ-8. Benefit from entacapone appeared to be relatively uniform across subgroups (e.g., number of daily levodopa doses, use of other anti-PD medications).

Study limitations: The results of this study may be biased due to factors inherent in open-label, community-based trials (e.g., compliance). This is, however, reflective of everyday clinical practice.

Conclusions: In this naturalistic, real-life study, the addition of entacapone to levodopa therapy provided benefits in quality of life and activities of daily living for a substantial proportion of PD patients experiencing wearing-off.

Key words: :

• Entacapone
• Fluctuations
• Levodopa
• Parkinson's disease
• Wearing-off

Acknowledgements

Declaration of interest: The funding for this study was provided entirely by Novartis Pharmaceuticals Canada, Inc. Editorial assistance during the development of this manuscript was provided by Scott Moffatt at Pharm Team Communications. M.J., M.P., and O.S. have received research grants and consulting fees from Novartis. No fee for the preparation of this manuscript was received. B.R. and R.S are employees of Novartis.

Notes

* The data in this paper were previously presented as Poster No. P576, Jog M, Panisset M, Suchowersky O, et al: ‘Comtan early-off: evaluation of entacapone in patients with early signs and symptoms of L-dopa wearing-off’, at the Tenth International Congress of Parkinson’s Disease and Movement Disorders, 2006, Kyoto, Japan

* Novartis Pharmaceuticals, Basel, Switzerland