PMID- 25495896
OWN - NLM
STAT- MEDLINE
DCOM- 20160912
LR  - 20161011
IS  - 1563-5279 (Electronic)
IS  - 0020-7454 (Linking)
VI  - 126
IP  - 1
DP  - 2016
TI  - Long-term, open-label, safety study of once-daily ropinirole extended/prolonged 
      release in early and advanced Parkinson's disease.
PG  - 30-8
LID - 10.3109/00207454.2014.991924 [doi]
AB  - Long-term safety of once-daily ropinirole extended/prolonged release (ropinirole 
      XL/PR) was evaluated in subjects with early and advanced Parkinson's disease (PD) 
      in this study, 101468/248. Subjects (n = 419) who completed one of three prior 
      studies evaluating ropinirole XL/PR for the treatment of PD were enrolled in this 
      open-label, multicenter, extension study, and were to be followed for up to 73 
      months. Ropinirole XL/PR was titrated/continued, and adjusted as appropriate 
      during the maintenance phase (maximum 24 mg/d). Levodopa (L-dopa) and other 
      nondopamine agonist PD medications were permitted. Safety outcomes that were 
      investigated included frequency of adverse events (AEs). Subjects' preference 
      regarding once daily versus three times daily study medication regimens was also 
      investigated in a subset of the study population. The median duration of 
      ropinirole XL/PR exposure was 1275 d. Most subjects (87%) reported at least one 
      AE, with the most common (>/= 10%) AEs being, back pain (14%), hallucinations 
      (13%), somnolence (11%) and peripheral edema (11%). Twenty-five percent of 
      subjects discontinued the study prematurely due to an AE during the treatment 
      period. Long-term treatment with ropinirole XL/PR was not associated with any new 
      or unexpected safety concerns in patients with early and advanced PD, and a 
      majority of subjects preferred the once-daily dosing regimen.
FAU - Makumi, Clare W
AU  - Makumi CW
AD  - a US Medical Affairs -Medical Services , GlaxoSmithKline, Research Triangle Park, 
      North Carolina, USA.
FAU - Asgharian, Afsaneh
AU  - Asgharian A
AD  - b Clinical Statistics , GlaxoSmithKline, Research Triangle Park, North Carolina, 
      USA.
FAU - Ellis, Jeffrey
AU  - Ellis J
AD  - c R&D Projects, Clinical Platforms, & Sciences , GlaxoSmithKline, Research 
      Triangle Park, North Carolina, USA.
FAU - Shaikh, Soraya
AU  - Shaikh S
AD  - d Classic and Established Medicines , GlaxoSmithKline, Brentford, UK.
FAU - Jimenez, Teri
AU  - Jimenez T
AD  - b Clinical Statistics , GlaxoSmithKline, Research Triangle Park, North Carolina, 
      USA.
FAU - VanMeter, Susan
AU  - VanMeter S
AD  - e Neuroscience Therapy Area Unit , GlaxoSmithKline, Research Triangle Park, North 
      Carolina, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00632736
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141227
PL  - England
TA  - Int J Neurosci
JT  - The International journal of neuroscience
JID - 0270707
RN  - 0 (Antiparkinson Agents)
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  - Antiparkinson Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Back Pain/*chemically induced/epidemiology
MH  - Delayed-Action Preparations
MH  - Dopamine Agonists/administration & dosage/*adverse effects/therapeutic use
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Edema/*chemically induced/epidemiology
MH  - Fatigue/*chemically induced/epidemiology
MH  - Female
MH  - Hallucinations/*chemically induced/epidemiology
MH  - Humans
MH  - Indoles/administration & dosage/*adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/complications/*drug therapy
MH  - Patient Preference
MH  - Prevalence
OTO - NOTNLM
OT  - 101468/248
OT  - Clinicaltrials.gov trial number: NCT00632736
OT  - long-term treatment
OT  - ropinirole PR
OT  - ropinirole XL/PR
OT  - safety
EDAT- 2014/12/17 06:00
MHDA- 2016/09/13 06:00
CRDT- 2014/12/16 06:00
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2016/09/13 06:00 [medline]
AID - 10.3109/00207454.2014.991924 [doi]
PST - ppublish
SO  - Int J Neurosci. 2016;126(1):30-8. doi: 10.3109/00207454.2014.991924. Epub 2014 
      Dec 27.