Quality of life in Parkinson's disease patients following adjunctive tolcapone therapy: results of an open-label, multicenter, community-based trial.

Abstract

OBJECTIVE:

To examine changes in quality of life (QOL) and global clinical status after 30 days of adjunctive treatment with tolcapone, a revers-ible 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 > or = 65 years of age and 116 (57%) had Parkinson's disease for > or = 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.

• Authors: Kapil Sethi, Stewart Factor, Ray Watts
• Journal: CNS spectrums (CNS Spectr) Vol. 15 Issue 1 Pg. 27-32 (Jan 2010) ISSN: 1092-8529 [Print] United States
• PMID: 20394182 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antiparkinson Agents
• Benzophenones
• Nitrophenols
• Levodopa
• Tolcapone

Topics

• Adult
• Aged
• Aged, 80 and over
• Antiparkinson Agents (therapeutic use)
• Benzophenones (therapeutic use)
• Female
• Humans
• Levodopa (adverse effects, therapeutic use)
• Male
• Middle Aged
• Nitrophenols (therapeutic use)
• Parkinson Disease (drug therapy, psychology)
• Quality of Life
• Residence Characteristics
• Severity of Illness Index
• Surveys and Questionnaires
• Tolcapone
• United States
• Young Adult