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Clinical efficacy of Sinemet CR 50/200 versus Sinemet 25/100 in patients with fluctuating Parkinson's disease. An open, and a double-blind, double-dummy, multicenter treatment evaluation. The Dutch Sinemet CR Study Group.

AbstractIn a multicenter study we selected 84 patients with fluctuating Parkinson's disease in order to evaluate the effects of controlled-release Sinemet 50/200 (=CR) versus standard Sinemet 25/100 (=STD) in an open-label 8-week titration period, followed by a double-blind, double-dummy 24-week treatment period. In contrast with previous double-blind studies, the efficacy of Sinemet CR proved to be significantly superior to that of Sinemet-STD according to NYUPDS and NUDS rating scales. This higher efficacy of Sinemet CR was not achieved at the expense of safety and/or tolerability. Actual total daily levodopa dosage in patients treated with Sinemet CR was increased by 33%; however, the plasma level of this dosage is calculated to be similar to that of the previous dosage of Sinemet-STD (bio-availability of Sinemet CR is 71%). Mean numbers of daily doses, off-hours, and off-periods were decreased significantly during Sinemet CR treatment. Although all other variables suggest that the number of on-hours had to be increased, statistical significance could not be reached in this respect.
AuthorsE C Wolters, M W Horstink, R A Roos, E N Jansen (Affiliation: Department of Neurology, Free University Hospital, Amsterdam, The Netherlands.)
JournalClinical neurology and neurosurgery (Clin Neurol Neurosurg) Vol. 94 Issue 3 Pg. 205-11 ( 1992) ISSN: 0303-8467 NETHERLANDS
PMID1327609 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antiparkinson Agents
  • Drug Combinations
  • Levodopa
  • Carbidopa
  • Sinemet
Topics
  • Antiparkinson Agents (administration & dosage, adverse effects, pharmacokinetics)
  • Carbidopa (administration & dosage, adverse effects, pharmacokinetics)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Combinations
  • Female
  • Humans
  • Levodopa (administration & dosage, adverse effects, pharmacokinetics)
  • Male
  • Middle Aged
  • Neurologic Examination (drug effects)
  • Parkinson Disease (blood, diagnosis, drug therapy)
  • Patient Satisfaction
  • Sleep Stages (drug effects)