PMID- 25114789
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140812
LR  - 20220331
IS  - 2047-9158 (Print)
IS  - 2047-9158 (Electronic)
IS  - 2047-9158 (Linking)
VI  - 3
DP  - 2014
TI  - The efficacy and safety of pramipexole ER versus IR in Chinese patients with 
      Parkinson's disease: a randomized, double-blind, double-dummy, parallel-group 
      study.
PG  - 11
LID - 10.1186/2047-9158-3-11 [doi]
AB  - OBJECTIVE: To evaluate the non-inferiority of pramipexole extended-release (ER) 
      versus immediate-release (IR) in Chinese patients with Parkinson's disease (PD) 
      in a double-blind, randomized, parallel-group study. METHODS: Subjects were 
      Chinese patients with idiopathic PD with diagnosis >/= 2 years prior to trial, 
      age >/= 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during 
      'on'-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). 
      Non-inferiority was based on the primary endpoint, the change from baseline to 
      end of maintenance (week 18) in the UPDRS (Parts II + III) total score. RESULTS: 
      For the primary endpoint, the adjusted mean changes (standard error) of UPDRS 
      Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR 
      formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed 
      effect) and baseline (covariate). The adjusted mean between group difference was 
      0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 
      95% CI (-1.047) for treatment difference was higher than the non-inferiority 
      margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The 
      incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm 
      with few severe AEs (ER: 2.1%; IR: 3.8%). CONCLUSION: Based on the UPDRS II + III 
      score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of 
      pramipexole ER and IR were similar. These results were based on comparable mean 
      daily doses and durations of treatment for both formulations.
FAU - Wang, Ying
AU  - Wang Y
AD  - Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, 
      Shanghai, China.
FAU - Sun, Shenggang
AU  - Sun S
AD  - Union Hospital affiliated to Tongji Medical College of Huazhong University of 
      Science and Technology, Wuhan, China.
FAU - Zhu, Suiqiang
AU  - Zhu S
AD  - Tongji Hospital affiliated to Tongji Medical College of Huazhong University of 
      Science and Technology, Wuhan, China.
FAU - Liu, Chunfeng
AU  - Liu C
AD  - The Second Affiliated Hospital of Soochow University, Suzhou, China.
FAU - Liu, Yiming
AU  - Liu Y
AD  - Qilu Hospital affiliated to Shandong University, Jinan, China.
FAU - Di, Qing
AU  - Di Q
AD  - Nanjing Brain Hospital, Nanjing, China.
FAU - Shang, Huifang
AU  - Shang H
AD  - West China Hospital affiliated to Sichuan University, Chengdu, China.
FAU - Ren, Yan
AU  - Ren Y
AD  - First Affiliated Hospital of China Medical University, Shenyang, China.
FAU - Lu, Changhong
AU  - Lu C
AD  - Boehringer Ingelheim International Trading (Shanghai) Co, Ltd, Shanghai, China.
FAU - Gordon, Mark Forrest
AU  - Gordon MF
AD  - Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
FAU - Juhel, Nolwenn
AU  - Juhel N
AD  - Boehringer Ingelheim France S.A.S, Reims, France.
FAU - Chen, Shengdi
AU  - Chen S
AD  - Department of Neurology, Ruijin Hospital affiliated to Shanghai Jiaotong 
      University School of Medicine, Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20140602
PL  - England
TA  - Transl Neurodegener
JT  - Translational neurodegeneration
JID - 101591861
PMC - PMC4128609
OTO - NOTNLM
OT  - Non-inferiority
OT  - Parkinson's disease
OT  - Pramipexole ER
OT  - Pramipexole IR
OT  - Safety
OT  - Unified Parkinson's Disease Rating Scale (UPDRS)
EDAT- 2014/08/13 06:00
MHDA- 2014/08/13 06:01
PMCR- 2014/06/02
CRDT- 2014/08/13 06:00
PHST- 2014/02/13 00:00 [received]
PHST- 2014/05/19 00:00 [accepted]
PHST- 2014/08/13 06:00 [entrez]
PHST- 2014/08/13 06:00 [pubmed]
PHST- 2014/08/13 06:01 [medline]
PHST- 2014/06/02 00:00 [pmc-release]
AID - 2047-9158-3-11 [pii]
AID - 10.1186/2047-9158-3-11 [doi]
PST - epublish
SO  - Transl Neurodegener. 2014 Jun 2;3:11. doi: 10.1186/2047-9158-3-11. eCollection 
      2014.