title: Tolcapone in stable Parkinson's disease: efficacy and safety of long-term treatment. Tolcapone Stable Study Group.
abstract: 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.
authors.affiliation: University of Southern California, Los Angeles 90033, USA.
authors.forename: C H
authors.initials: CH
authors.lastname: Waters
authors.forename: M
authors.initials: M
authors.lastname: Kurth
authors.forename: P
authors.initials: P
authors.lastname: Bailey
authors.forename: L M
authors.initials: LM
authors.lastname: Shulman
authors.forename: P
authors.initials: P
authors.lastname: LeWitt
authors.forename: E
authors.initials: E
authors.lastname: Dorflinger
authors.forename: D
authors.initials: D
authors.lastname: Deptula
authors.forename: S
authors.initials: S
authors.lastname: Pedder
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001577:Benzophenones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D065098:Catechol O-Methyltransferase Inhibitors; D015259:Dopamine Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009596:Nitrophenols; D010300:Parkinson Disease / Q000188:drug therapy* / Q000201:enzymology; D013997:Time Factors; D000077867:Tolcapone; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D001577:Benzophenones; D065098:Catechol O-Methyltransferase Inhibitors; D015259:Dopamine Agents; D004791:Enzyme Inhibitors; D009596:Nitrophenols; D007980:Levodopa; D000077867:Tolcapone