Evidence map›Paper›PMID 32821737›Full record

ArticleJournal of lipid and atherosclerosis2020

Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin.

Hyoeun Kim, Chan Joo Lee, Donghoon Choi, Byeong-Keuk Kim, In-Cheol Kim, Jung-Sun Kim, Chul-Min Ahn, Geu-Ru Hong, In-Jeong Cho, Chi-Young Shim and 1 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Journal of lipid and atherosclerosis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03949374. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 39% 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.

NCT03949374 phase4completed

A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

Ran2015Enrolled126Registered outcomes8Posted comparisons0ConditionsDyslipidemias, HypercholesterolemiaArmsCRESTOR, reference formulation of rosuvastatin, ROVASRO, generic formulation of rosuvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
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

11 authors at 4 institutions in 1 country.

Hyoeun KimDepartment of Health Promotion, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7334-9700
Chan Joo LeeDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-8756-409X
Donghoon ChoiDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-2009-9760
Byeong-Keuk KimDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-2493-066X
In-Cheol KimDivision of Cardiology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University College of Medicine, Daegu, Korea.ORCID https://orcid.org/0000-0002-5751-2328
Jung-Sun KimDivision of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0003-2263-3274
Chul-Min AhnDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7071-4370
Geu-Ru HongDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-4981-3304
In-Jeong ChoDivision of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-1209-5129
Chi-Young ShimDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-6136-0136
Sang-Hak LeeDivision of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-4535-3745
Yonsei University · KREwha Womans University · KRKeimyung University Dongsan Medical Center · KRKorea Health Promotion Institute · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to investigate whether a new generic rosuvastatin is non-inferior to a proprietary one in terms of lipid-lowering efficacy. We also evaluated its non-lipid effects including adverse events.

methodsOne-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened. After a 4-week run-in period, 126 individuals who met the lipid criteria for drug therapy were randomly assigned to receive the new generic or proprietary rosuvastatin 10 mg daily for 8 weeks. The primary outcome variables were low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement. Hematological and biochemical parameters and adverse events were assessed.

resultsAfter 8 weeks of drug treatment, the mean percentage change in LDL-C was not different between the groups (-45.5%±19.9% and -45.1%±19.0% for generic and proprietary rosuvastatin, respectively;

conclusionThe new generic rosuvastatin was non-inferior to the proprietary rosuvastatin in terms of lipid-lowering efficacy. The rosuvastatin formulations did not exhibit clinically significant non-lipid effects with good safety profiles. Our study provides comprehensive data regarding 2 rosuvastatin formulations in East Asian subjects.

trial registrationClinicalTrials.gov Identifier: NCT03949374.

Indexed as

Alanine transaminaseBlood pressureCholesterol, LDLHematologyRosuvastatin calcium

Identifiers

PMID32821737
PMCPMC7379087
OpenAlexW3010086048

What OpenQuestion holds

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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.