Tolcapone in stable Parkinson's disease: efficacy and safety of long-term treatment. The Tolcapone Stable Study Group.
In this double-blind, placebo-controlled trial, we investigated the effect of the catechol-O-methyltransferase inhibitor tolcapone 100 or 200 mg three times daily on activities of daily living and motor function in 298 patients with parkinsonism receiving levodopa but without motor fluctuations. At 6 months, both dosages of tolcapone produced significant reductions in the Unified Parkinson's Disease Rating Scale scores for activities of daily living (Subscale II) and motor function (Subscale III) and in the total score for Subscales I to III. These improvements were maintained up to the 12-month assessment. At 6 months, both tolcapone groups had changes in levodopa dosage that were significantly different from placebo: the tolcapone groups had decreases in mean total daily dose of levodopa, whereas the placebo group had a mean increase. Tolcapone was well tolerated. The principal adverse events were levodopa-related, but these were generally mild or moderate. Diarrhea was the most frequent nondopaminergic adverse event. Tolcapone appears to be beneficial in the treatment of patients with parkinsonism who have not yet developed motor fluctuations.
Waters
C H
CH
University of Southern California School of Medicine, Division of Movement Disorders, Los Angeles 90033, USA.
Kurth
M
M
Bailey
P
P
Shulman
L M
LM
LeWitt
P
P
Dorflinger
E
E
Deptula
D
D
Pedder
S
S
D000203:Activities of Daily Living; D000368:Aged; D000978:Antiparkinson Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001577:Benzophenones / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007980:Levodopa / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects; D009596:Nitrophenols; D010300:Parkinson Disease / Q000175:diagnosis / Q000188:drug therapy*; D010919:Placebos; D018434:Sickness Impact Profile; D000077867:Tolcapone; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D001577:Benzophenones; D009596:Nitrophenols; D010919:Placebos; D007980:Levodopa; D000077867:Tolcapone