Immediate-release and controlled-release carbidopa/levodopa in PD: a 5-year randomized multicenter study. Carbidopa/Levodopa Study Group.

摘要: Objective To compare effects of immediate-release (IR) and sustained-release (CR) carbidopa/levodopa in levodopa-naive PD patients. Background It was hypothesized that the long-acting preparation would be associated with fewer long-term complications. Methods A total 618 patients were studied 36 centers worldwide a blinded, randomized parallel study. Measures efficacy adverse reactions recorded at 3-month intervals for 5 years. Motor fluctuations dyskinesias evaluated by patient diary physician-recorded questionnaire. The Nottingham Health Profile (NHP) used to evaluate quality life. Results Approximately 60% completed trial. After years, mean dose IR 426 mg/day, bioavailable CR 510 mg/day (mean dose, 736 mg/day). 20.6% group 21.8% had motor or dyskinesia. Sixteen percent both groups changes response questionnaire's definition. There no significant difference between two treatment groups. Disability scores score Unified Parkinson Disease Rating Scale (UPDRS) highest baseline, improved therapy, thereafter worsened over time reach baseline scoring end superior Activities Daily Living subsection UPDRS all years emotional reactivity social isolation on NHP; however, this may have resulted from higher doses used. Conclusion Despite progressive nature PD, formulations maintained similar level control after compared baseline. Additionally, low incidence dyskinesia not significantly different partly attributed relatively levodopa throughout 5-year