Quality of life in Parkinson's disease patients following adjunctive tolcapone therapy: results of an open-label, multicenter, community-based trial.
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.
Sethi
Kapil
K
Department of Neurology, Medical College of Georgia, 1120 15th St, Augusta, GA 30912, USA. ksethi@mcg.edu
Factor
Stewart
S
Watts
Ray
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D001577:Benzophenones / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007980:Levodopa / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009596:Nitrophenols / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000188:drug therapy* / Q000523:psychology*; D011788:Quality of Life; D012111:Residence Characteristics; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D000077867:Tolcapone; D014481:United States; D055815:Young Adult
D000978:Antiparkinson Agents; D001577:Benzophenones; D009596:Nitrophenols; D007980:Levodopa; D000077867:Tolcapone