Evidence map›Paper›PMID 25114789›Full record

ArticleTranslational neurodegeneration2014

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.

Ying Wang, Shenggang Sun, Suiqiang Zhu, Chunfeng Liu, Yiming Liu, Qing Di, Huifang Shang, Yan Ren, Changhong Lu, Mark Forrest Gordon and 2 more

Open access · goldAbstract read
In one paragraph

Article in Translational neurodegeneration, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 11 institutions in 3 countries.

Ying WangRuijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shenggang SunUnion Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Suiqiang ZhuTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Chunfeng LiuThe Second Affiliated Hospital of Soochow University, Suzhou, China.
Yiming LiuQilu Hospital affiliated to Shandong University, Jinan, China.
Qing DiNanjing Brain Hospital, Nanjing, China.
Huifang ShangWest China Hospital affiliated to Sichuan University, Chengdu, China.
Yan RenFirst Affiliated Hospital of China Medical University, Shenyang, China.
Changhong LuBoehringer Ingelheim International Trading (Shanghai) Co, Ltd, Shanghai, China.
Mark Forrest GordonBoehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
Nolwenn JuhelBoehringer Ingelheim France S.A.S, Reims, France.
Shengdi ChenDepartment of Neurology, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Shanghai Jiao Tong University · CNBoehringer Ingelheim (China) · CNBoehringer Ingelheim (France) · FRBoehringer Ingelheim (United States) · USChina Medical University · CNNanjing Brain Hospital · CNQilu Hospital of Shandong University · CNSecond Affiliated Hospital of Soochow University · CNTongji Hospital · CNWest China Hospital of Sichuan University · CNWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

methodsSubjects 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.

resultsFor 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%).

conclusionBased 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.

Indexed as

Non-inferiorityParkinson’s diseasePramipexole ERPramipexole IRSafetyUnified Parkinson’s Disease Rating Scale (UPDRS)

Identifiers

PMID25114789
PMCPMC4128609
OpenAlexW2144526889

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.