[The effect of controlled release of DOPA and carbidopa on clinical response and plasma pharmacokinetics of DOPA in parkinsonian patients].Neurologia. 1997 Apr; 12(4):145-56.N
This is a multicentric double blind comparison of the effects of standard and slow release levodopa + carbidopa formulations in patients with Parkinson's disease. Sixty four patients with simple fluctuations were included and 43 finished the study. The study had three phases: a) optimal dose findings phase with standard levodopa + carbidopa; b) open label, cross over study with the two formulations, and c) double blind, parallel investigation. The following results were obtained. There was not a difference in the severity of disability according to UPDRS, part 3, scores though the subjective impressions of patients were in favor of standard formulations. The Sustained release levodopa + carbidopa produced significant improvement of dystonia in off period, pain due to akinesia in off and the number of hours in off and the quality and latency of sleep. In addition there was a tendency in favor of slow release compounds for early morning akinesia, global effect and impression of the examining physician. Low protein diet improved the kinetics of levodopa and the clinical response with both formulations. The clinical usefulness of standard and slow release levodopa + carbidopa formulation should be weighted according to individual problems of patients with Parkinson's disease.