TOLCAPONE IN STABLE PARKINSONS-DISEASE - EFFICACY AND SAFETY OF LONG-TERM TREATMENT

In this double-blind, placebo-controlled trial, we investigated the ef fect of the catechol-O-methyltransferase inhibitor tolcapone 100 or 20 0 mg three times daily on activities of daily living and motor functio n in 298 patients with parkinsonism receiving levodopa but without mot or fluctuations. At 6 months, both dosages of tolcapone produced signi ficant reductions in the Unified Parkinson's Disease Rating Scale scor es for activities of daily living (Subscale II) and motor function (Su bscale III) and in the total score for Subscales I to III. These impro vements were maintained up to the 12-month assessment. At 6 months, bo th tolcapone groups had changes in levodopa dosage that were significa ntly different from placebo: the tolcapone groups had decreases in mea n total daily dose of levodopa, whereas the placebo group had a mean i ncrease. Tolcapone was well tolerated. The principal adverse events we re levodopa-related, but these were generally mild or moderate. Diarrh ea was the most frequent nondopaminergic adverse event. Tolcapone appe ars to be beneficial in the treatment of patients with parkinsonism wh o have not yet developed motor fluctuations.