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Quality of Life in Parkinson's Disease Patients Following Adjunctive Tolcapone Therapy: Results of an Open-Label, Multicenter, Community-Based Trial

Published online by Cambridge University Press:  07 November 2014

Kapil Sethi ,
Stewart Factor  and
Ray Watts
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Abstract

Objective: To examine changes in quality of life (QOL) and global clinical status after 30 days of adjunctive treatment with tolcapone, a reversible inhibitor of catechol-O-methyltransferase, in patients with fluctuating Parkinson's disease.

Methods: This 30-day, multicenter, open-label, community-based study enrolled fluctuating Parkinson's disease patients to receive tolcapone 100 mg TID as an adjunct to levodopa/carbidopa. The primary end point was QOL change assessed using the Parkinson's Disease Questionnaire (PDQ)-8. Clinical change was assessed using the investigator-rated Clinical Global Impression of Improvement Scale (CGI-I).

Results: Fifty-six physicians enrolled 202 patients; 138 (68%) were ≥65 years of age and 116 (57%) had Parkinson's disease for ≥5 years. The mean PDQ-8 total score improved from 42.1 to 34.8 after 30 days of tolcapone (P<.0001). Sixty-nine percent of patients improved on the CGI-I. Physicians planned to continue tolcapone beyond the 30 days in 72%, most commonly because of positive changes in motor function and overall general improvement. No patient discontinued because of liver adverse events.

Conclusions: Adjunctive tolcapone treatment was associated with statistically significant improvement in QOL in fluctuating Parkinson's disease patients. A majority of patients experienced clinical benefits and continued treatment beyond the end of this study. No liver-related adverse events were reported.

Type
Original Research
Information
CNS Spectrums , Volume 15 , Issue 1 , January 2010 , pp. 27 - 32
Copyright
Copyright © Cambridge University Press 2010

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