PMID- 25586298
OWN - NLM
STAT- MEDLINE
DCOM- 20150918
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 4
DP  - 2015 Apr
TI  - An open-label extension study to evaluate the safety of ropinirole prolonged 
      release in Chinese patients with advanced Parkinson's disease.
PG  - 723-30
LID - 10.1185/03007995.2015.1005835 [doi]
AB  - OBJECTIVE: This open-label extension (OLE) study evaluated the safety profile of 
      ropinirole prolonged release (PR) administered for 24 weeks as adjunctive to 
      levodopa in Chinese patients with advanced Parkinson's disease (PD). METHODS: 
      This was a 24 week, flexible-dose, OLE study in Chinese patients with advanced PD 
      who received 24 week treatment with ropinirole PR in the preceding double-blind 
      (DB), phase III study (NCT01154166) and had no break in receiving study treatment 
      while switching from the DB study to the OLE study. In the OLE study, patients 
      received ropinirole PR once daily, starting with 2 mg/d and increasing up to 
      8 mg/d at week 4 (2 mg increment/week); if tolerable, the dose could be further 
      increased in 4 mg increments up to 24 mg/d according to clinical judgment. There 
      were no efficacy assessments. Safety assessments included monitoring adverse 
      events (AEs), neurological examination, Gambling Symptom Assessment Scale 
      questionnaire, liver chemistry, and laboratory tests. RESULTS: Of the 295 
      enrolled patients, 282 completed the study. The most common reason for withdrawal 
      was AEs (n = 9, 3.1%). The mean duration to ropinirole PR treatment was 173.1 
      days and an overall median daily dose of ropinirole was 8 mg (range: 2-24 mg). 
      Overall, 114 (38.6%) patients experienced on-treatment AEs; the most frequent 
      reported AEs ( >/= 2%) were dyskinesia (6.1%), dizziness (4.1%), nausea (3.4%), 
      hallucinations (3.4%), somnolence (2.7%) and decreased weight (2.4%). Sixty-eight 
      patients (23.1%) experienced treatment-related AEs. Six patients experienced 
      serious AEs (SAEs), of which hallucination was determined to be a 
      treatment-related SAE. There were no other significant safety findings. No new 
      safety signals for ropinirole were identified. CONCLUSION: The safety profile of 
      ropinirole was consistent with the preceding DB study and also with the 
      established safety profile for ropinirole. Results support the long-term use of 
      ropinirole PR as an adjunctive to levodopa in Chinese patients with advanced PD. 
      ClinicalTrials.gov identifier: NCT 1536574.
FAU - Zhang, Zhenxin
AU  - Zhang Z
AD  - Department of Neurology, Peking Union Medical College Hospital , Beijing , China.
FAU - Wang, Jian
AU  - Wang J
FAU - Zhang, Xiaoying
AU  - Zhang X
FAU - Chen, Shengdi
AU  - Chen S
FAU - Wang, Zhenfu
AU  - Wang Z
FAU - Zhang, Baorong
AU  - Zhang B
FAU - Liu, Chunfeng
AU  - Liu C
FAU - Qu, Qiumin
AU  - Qu Q
FAU - Cheng, Yan
AU  - Cheng Y
FAU - Zhu, Rongxuan
AU  - Zhu R
FAU - Li, Jie
AU  - Li J
FAU - Hu, Jingqiu
AU  - Hu J
FAU - Cai, Meng
AU  - Cai M
LA  - eng
SI  - ClinicalTrials.gov/NCT01536574
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150312
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Indoles)
RN  - 030PYR8953 (ropinirole)
RN  - 46627O600J (Levodopa)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antiparkinson Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Asian People
MH  - Delayed-Action Preparations
MH  - Drug Liberation
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage/adverse effects/*therapeutic use
MH  - Levodopa/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - Open-label extension
OT  - Parkinson's disease
OT  - Ropinirole prolonged release
OT  - Safety
EDAT- 2015/01/15 06:00
MHDA- 2015/09/19 06:00
CRDT- 2015/01/15 06:00
PHST- 2015/01/15 06:00 [entrez]
PHST- 2015/01/15 06:00 [pubmed]
PHST- 2015/09/19 06:00 [medline]
AID - 10.1185/03007995.2015.1005835 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Apr;31(4):723-30. doi: 10.1185/03007995.2015.1005835. 
      Epub 2015 Mar 12.