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Abstract:
(1) Entacapone, a catechol-O-methyltransferase inhibitor, is indicated, in combination with levodopa + a dopadecarboxylase inhibitor, for the treatment of parkinsonian patients who have motor fluctuations on levodopa therapy. (2) The clinical file contains only placebo-controlled trials. (3) The two main clinical trials involved patients with moderate fluctuations while on levodopa, usually combined with other antiparkinsonian drugs. They showed a moderate effect of entacapone, with an increased duration of motor improvement ("on" periods) of approximately one hour, but one trial showed no increase in overall patient satisfaction. (4) In clinical trials the main adverse effects of entacapone were dyskinesias and gastrointestinal disorders (especially diarrhoea and abdominal pain). Given the limited number of patients included in these clinical trials, the risk of rare but severe adverse effects (especially hepatitis) cannot be ruled out. (5) Entacapone therapy can cost up to four times more than treatment with bromocriptine.