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From the Department of Neurology (Dr. Rinne), Turku University Hospital, Finland; the Department of Neurology (Dr. Larsen), Central Hospital, Stavanger, Norway; the Department of Neurology (Dr. Siden), Huddinge Hospital, Sweden; and the Department of Neurology (Dr. Worm-Petersen), Gentofte Hospital, Copenhagen, Denmark.
Address correspondence and reprint requests to Dr. Urpo K. Rinne, Department of Neurology, University of Turku, Kiinamyllynkatu 4-8, FIN-20520 Turku, Finland.
Objective: To study the effect and safety of entacapone as an adjunct to levodopa treatment in patients with PD with wearing-off motor fluctuations.
Background: Entacapone is a catechol-O-methyltransferase (COMT) inhibitor that has been shown to increase the area under the concentration-time curve of plasma levodopa by decreasing its systemic elimination, thereby promoting and improving therapeutic response to it.
Methods: A total of 171 parkinsonian patients with wearing-off-type motor fluctuations participated in a 6-month randomized, placebo-controlled, double-blind, parallel-group study. The extent of therapeutic response was elicited in the first hand with home diary recordings of "on" and "off" times by the patient and with Unified Parkinson's Disease Rating Scale scoring by the examiner. The patients took either 200 mg entacapone or identical placebos concomitantly with each daily levodopa dose (four to 10 times a day).
Results: Patients' home diaries indicated that entacapone increased the mean (± SD) "on" time significantly (9.3 ± 2.2 to 10.7 ± 2.2 hours; p < 0.01) and correspondingly decreased the "off" time significantly (5.3 ± 2.2 to 4.2 ± 2.2 hours; p < 0.001). The average benefit derived from a daily levodopa dose as related by the patients was increased significantly (p < 0.01). The daily levodopa dose was reduced significantly in the entacapone group, the difference between the groups being 102 mg (p < 0.01). The entacapone-derived increase in the benefit from levodopa was lost almost completely following its withdrawal. Entacapone was well tolerated. Dopaminergic adverse events, which increased, were ameliorated by reducing the levodopa dose. Diarrhea was the most common nondopaminergic adverse event.
Conclusions: Long-term entacapone treatment effectively prolonged the beneficial response to levodopa in parkinsonian patients with the wearing-off phenomenon. The improvement occurred irrespective of the reduction of the levodopa dose.
*See the Appendix on page 1313 for a listing of Nomecomt Study Group members.
Supported in part by Orion Pharma, Espoo, Finland.
Presented as an abstract at the annual meeting of the American Neurological Association; Miami, FL; October 1996.
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