PATIENT AND PHYSICIAN GLOBAL PERCEPTION OF LEVODOPA/CARBIDOPA/ENTACAPONE VS LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING EARLY WEARING-OFF

Author(s)

Ruyra J1, Balañá M1, Lahoz R2, Hernandez B3, Tolosa E31Novartis Pharma, Barcelona, Barcelona, Spain, 2Novartis Farmacéutica S.A., Barcelona, Barcelona, Spain, 3Hospital Clínic de Barcelona, Barcelona, Barcelona, Spain

OBJECTIVES: To compare patients’ and physicians’ global perceptions of Parkinson’s disease (PD) in two treatment groups: levodopa/carbidopa/entacapone (LCE) vs. levodopa/carbidopa (LC). METHODS: Multicentre, double-blind, randomised phase IV study. Ninety-five PD patients with early wearing-off (WO) and deterioration of activities of daily living (ADLs) were randomised to receive LCE (n=46) or LC (n=49) with a 3-month follow-up. Patient and physician global perception of PD was assessed at the end of the study. The PDQ-39 quality of life (QoL) questionnaire, and the longitudinal course of PD using the different parts of UPDRS (part I, part II, part III, and IV) were evaluated along the study. Differences between health improvement by patient and physician were analyzed by the Mann Whitney U-test. The mean differences from baseline to final visit in PDQ-39 and in UPDRS (part I, II, IIII IV) score were analyzed by an ANCOVA model.  RESULTS: Mean (SD) age was 66.4±8.6 years and 50.0% were women. Half percent of patients showed stage II according to the Hoehn and Yahr classification. Patient global perception showed a significant better score in the LCE than in LC group (-0.9±1.0 LCE and -0.4±1.17 LC, p=0. 0291). Similar results were obtained by the physician (-0.3±0.8 vs -0.4, p=0. 0017). The adjusted mean differences in the PDQ-39 showed a trend for a higher improvement in QoL in the LCE group (6.3±20.4 vs 0.81±15.6), although did not reach statistical significance. The UPDRS evaluation showed a significant higher response in part II and III (p=0.0078 and p=0.0072, respectively). A trend to better results for the LCE group was observed in part I and IV. CONCLUSIONS: Levodopa/carbidopa/entacapone shows a significant better patient and physician global perception in the LCE treatment group vs LC group in PD patients with early WO and ADLs deterioration.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PND37

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Neurological Disorders

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