PMID- 21244307
OWN - NLM
STAT- MEDLINE
DCOM- 20120326
LR  - 20121115
IS  - 1563-5279 (Electronic)
IS  - 0020-7454 (Linking)
VI  - 121
IP  - 5
DP  - 2011 May
TI  - Long-term, open-label study of once-daily ropinirole prolonged release in early 
      Parkinson's disease.
PG  - 246-53
LID - 10.3109/00207454.2010.546538 [doi]
AB  - Long-term safety and efficacy of once-daily ropinirole prolonged release (PR) 
      were evaluated in subjects with early Parkinson's disease (PD). Subjects (n = 83) 
      who completed one of two studies were enrolled in this open-label, multicenter, 
      extension study, and followed for up to 78 months. Ropinirole PR was 
      titrated/continued, and adjusted as appropriate during the maintenance phase 
      (maximum 24 mg/day). L-dopa and other non-dopamine agonist PD medications were 
      permitted. Safety outcomes included adverse events (AEs). Efficacy outcomes 
      included Unified Parkinson's Disease Rating Scale (UPDRS) II and III scores, and 
      Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) scores. The 
      median duration of ropinirole PR exposure was 1,069 days. Most subjects (97.6%) 
      reported at least one AE, most commonly (>/= 30%) nausea (42.2%), dizziness 
      (41.0%), peripheral edema (38.6%), back pain (33.7%), and headache (31.3%). 
      Seventeen (20.5%) subjects discontinued due to an AE. UPDRS and CGI scores 
      indicated that the clinical status of subjects was maintained throughout the 
      treatment period. In patients with early PD, long-term treatment with once-daily 
      ropinirole PR was not associated with any new safety concerns, and was effective 
      in maintaining clinical status. These results support the extended use of 
      ropinirole PR for treatment of PD.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - Departments of Neurology, Molecular Pharmacology and Physiology, University of 
      South Florida, Tampa, Florida 33606, USA. rhauser@health.usf.edu
FAU - Reichmann, Heinz
AU  - Reichmann H
FAU - Lew, Mark
AU  - Lew M
FAU - Asgharian, Afsaneh
AU  - Asgharian A
FAU - Makumi, Clare
AU  - Makumi C
FAU - Shulman, Kenneth J
AU  - Shulman KJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00650104
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110119
PL  - England
TA  - Int J Neurosci
JT  - The International journal of neuroscience
JID - 0270707
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dopamine Agonists)
RN  - 0 (Indoles)
RN  - 030PYR8953 (ropinirole)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations/administration & dosage/adverse effects
MH  - Dopamine Agonists/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Indoles/*administration & dosage/adverse effects
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Severity of Illness Index
MH  - Time
EDAT- 2011/01/20 06:00
MHDA- 2012/03/27 06:00
CRDT- 2011/01/20 06:00
PHST- 2011/01/20 06:00 [entrez]
PHST- 2011/01/20 06:00 [pubmed]
PHST- 2012/03/27 06:00 [medline]
AID - 10.3109/00207454.2010.546538 [doi]
PST - ppublish
SO  - Int J Neurosci. 2011 May;121(5):246-53. doi: 10.3109/00207454.2010.546538. Epub 
      2011 Jan 19.