title: 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.
abstract: 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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Shenggang
authors.initials: S
authors.lastname: Sun
authors.affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Suiqiang
authors.initials: S
authors.lastname: Zhu
authors.affiliation: The Second Affiliated Hospital of Soochow University, Suzhou, China.
authors.forename: Chunfeng
authors.initials: C
authors.lastname: Liu
authors.affiliation: Qilu Hospital affiliated to Shandong University, Jinan, China.
authors.forename: Yiming
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Nanjing Brain Hospital, Nanjing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Di
authors.affiliation: West China Hospital affiliated to Sichuan University, Chengdu, China.
authors.forename: Huifang
authors.initials: H
authors.lastname: Shang
authors.affiliation: First Affiliated Hospital of China Medical University, Shenyang, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Ren
authors.affiliation: Boehringer Ingelheim International Trading (Shanghai) Co, Ltd, Shanghai, China.
authors.forename: Changhong
authors.initials: C
authors.lastname: Lu
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
authors.forename: Mark Forrest
authors.initials: MF
authors.lastname: Gordon
authors.affiliation: Boehringer Ingelheim France S.A.S, Reims, France.
authors.forename: Nolwenn
authors.initials: N
authors.lastname: Juhel
authors.affiliation: Department of Neurology, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Shengdi
authors.initials: S
authors.lastname: Chen
keywords: Non-inferiority; Parkinson’s disease; Pramipexole ER; Pramipexole IR; Safety; Unified Parkinson’s Disease Rating Scale (UPDRS)
references.citation: J Psychiatr Res. 1975 Nov;12(3):189-98
references.pmid: 1202204
references.citation: J Neurol Neurosurg Psychiatry. 1999 Apr;66(4):436-41
references.pmid: 10201413
references.citation: Neurology. 1967 May;17(5):427-42
references.pmid: 6067254
references.citation: Neurology. 2011 Aug 23;77(8):767-74
references.pmid: 21832216
references.citation: Transl Neurodegener. 2012 May 24;1(1):10
references.pmid: 23211041
references.citation: JAMA. 1997 Jul 9;278(2):125-30
references.pmid: 9214527
references.citation: Eur J Neurol. 2012 Jan;19(1):155-62
references.pmid: 22175760
references.citation: Mov Disord. 2010 Nov 15;25(15):2542-9
references.pmid: 20669317
references.citation: Clin Neuropharmacol. 1995 Aug;18(4):338-47
references.pmid: 8665547
references.citation: Sleep. 1991 Dec;14(6):540-5
references.pmid: 1798888
references.citation: Clin Neuropharmacol. 2012 Jul-Aug;35(4):174-81
references.pmid: 22801294
references.citation: Lancet. 2002 May 4;359(9317):1589-98
references.pmid: 12047983
references.citation: J Neurol Sci. 2003 Dec 15;216(1):81-7
references.pmid: 14607306
references.citation: Neurol Sci. 2011 Feb;32(1):23-30
references.pmid: 21174138
references.citation: Neurology. 2011 Aug 23;77(8):759-66
references.pmid: 21832218
references.citation: JAMA. 2000 Oct 18;284(15):1931-8
references.pmid: 11035889