Evidence map›Paper›PMID 33763199›Full record

ArticleParkinson's disease2021

Efficacy and Safety of Pramipexole Sustained Release versus Immediate Release Formulation for Nocturnal Symptoms in Chinese Patients with Advanced Parkinson's Disease: A Pilot Study.

Haiyan Zhou, Shuhua Li, Hongmei Yu, Shenggang Sun, Xinhua Wan, Xiaodong Zhu, Chun-Feng Liu, Ling Chen, Wei Xiang, Yaqing Sun and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Parkinson's disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03521635 (A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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.

NCT03521635 phase4completednot on this map

A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)

TypeinterventionalSponsorBoehringer IngelheimRan2018 to 2020Enrolled98ConditionsParkinson DiseaseArmsPramipexole SR, Pramipexole IR
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
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 8 institutions in 1 country.

Haiyan ZhouDepartment of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shuhua LiDepartment of Neurology, Beijing Hospital, National Center of Gerontology, Beijing, China.
Hongmei YuDepartment of Neurology, The First Hospital of China Medical University, Shenyang, China.
Shenggang SunDepartment of Neurology, Wuhan Union Hospital, Wuhan, China.
Xinhua WanDepartment of Neurology, Peking Union Medical College Hospital, Beijing, China.
Xiaodong ZhuDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin, China.
Chun-Feng LiuDepartment of Neurology and Suzhou Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Ling ChenDepartment of Neurology, The First Affiliated Hospital, Sun Yet-Sen University, Guangzhou, China.
Wei XiangBoehringer Ingelheim (China), Shanghai, China.
Yaqing SunBoehringer Ingelheim (China), Shanghai, China.
Haibo ChenDepartment of Neurology, Beijing Hospital, National Center of Gerontology, Beijing, China.ORCID https://orcid.org/0000-0001-7077-4632
Shengdi ChenDepartment of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID https://orcid.org/0000-0002-6242-1025
Chinese Academy of Medical Sciences & Peking Union Medical College · CNBoehringer Ingelheim (China) · CNShanghai Jiao Tong University · CNFirst Hospital of China Medical University · CNSoochow University · CNSun Yat-sen University · CNTianjin Medical University General Hospital · CNWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore the efficacy and safety of pramipexole sustained release (SR) versus pramipexole immediate release (IR) in treating nocturnal symptoms in levodopa-treated Chinese patients with advanced Parkinson's disease (PD) and sleep disturbances.

methodSUSTAIN was an open-label, randomised, active-controlled parallel group exploratory pilot study (NCT03521635). A total of 98 patients were randomly allocated (1 : 1) to either pramipexole SR (

resultsThe mean pramipexole dose for both groups was 1.5 mg/day at week 18, and the mean changes in PDSS-2 total score for pramipexole SR and IR were -13.7 (95% CI -16.0 to -11.4) and -14.4 (-16.8 to -12.0) (difference of 0.7;

conclusionIn Chinese patients with advanced PD and sleep disturbances, pramipexole SR and IR have similar benefits in the treatment of nocturnal symptoms and safety, and an improvement from baseline in nocturnal symptoms was observed regardless of pramipexole formulation.

Identifiers

PMID33763199
PMCPMC7946461
OpenAlexW3134337211

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.