Evidence map›Paper›PMID 27506635›Full record

Trial reportCardiovascular therapeutics2016

Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe).

Kyung-Jin Kim, Sang-Hyun Kim, Young Won Yoon, Seung-Woon Rha, Soon-Jun Hong, Choong-Hwan Kwak, Weon Kim, Chang-Wook Nam, Moo-Yong Rhee, Tae-Ho Park and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Cardiovascular therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04895059 (Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT04895059 phase1completednot on this mapstarted 2017, after this paper: background citation

Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2017 to 2018Enrolled36ConditionsHealthyArmsRosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg, Ezetimibe 10mg
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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  8. A Comprehensive, Updated Review of Ezetimibe: Evidence-Based Clinical Use for Atherosclerotic Cardiovascular Disease.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Review
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  19. Fixed Combination for the Treatment of Dyslipidaemia.Current atherosclerosis reports · 2023
    Review
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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

20 authors at 18 institutions in 1 country.

Kyung-Jin KimDivision of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Sang-Hyun KimDivision of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
Young Won YoonDivision of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Seung-Woon RhaDepartment of Internal Medicine, Medical College, Korea University, Seoul, Korea.
Soon-Jun HongDivision of Cardiology, Department of Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.
Choong-Hwan KwakDivision of Cardiology, Department of Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Korea.
Weon KimCardiovascular Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea.
Chang-Wook NamDivision of Cardiology, Department of Internal Medicine, Dongsan Hospital, Keimyung University, Gyeongju, Korea.
Moo-Yong RheeCardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Korea.
Tae-Ho ParkDepartment of Internal Medicine, Cardiology Division, Dong-A University Hospital, Busan, Korea.
Taek-Jong HongPusan National University Hospital, Busan, Korea.
Sungha ParkDivision of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
Youngkeun AhnDepartment of Cardiology, Heart Center, Chonnam National University Hospital, Gwangju, Korea.
Namho LeeDivision of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Hui-Kyung JeonDepartment of Cardiovascular, Uijeongbu, Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
Dong-Woon JeonDivision of Cardiology, Department of Internal Medicine, NHIC Ilsan Hospital, Goyang, Korea.
Kyoo-Rok HanKangdong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Korea.
Keon-Woong MoonCardiology Division, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.
In-Ho ChaeCardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Korea. ihchae@snu.ac.kr.
Hyo-Soo KimDivision of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea. hyosoo@snu.ac.kr.
Korea University Medical Center · KRSeoul National University Hospital · KRChonnam National University Hospital · KRDong-A University Hospital · KRDongguk University Ilsan Hospital · KRGangnam Severance Hospital · KRGyeongsang National University Hospital · KRHallym University · KRKangdong Sacred Heart Hospital · KRKeimyung University · KRKyung Hee University Dental Hospital · KRNational Health Insurance Service Ilsan Hospital · KRPusan National University Hospital · KRSeoul National University Bundang Hospital · KRSNUH SMG-SNU Boramae Medical Center · KRThe Catholic University of Korea St. Vincent's Hospital · KRThe Catholic University of Korea Uijeongbu St. Mary's Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimWe aimed to compare the effects of fixed-dose combinations of ezetimibe plus rosuvastatin to rosuvastatin alone in patients with primary hypercholesterolemia, including a subgroup analysis of patients with diabetes mellitus (DM) or metabolic syndrome (MetS).

methodThis multicenter eight-week randomized double-blind phase III study evaluated the safety and efficacy of fixed-dose combinations of ezetimibe 10 mg plus rosuvastatin, compared with rosuvastatin alone in patients with primary hypercholesterolemia. Four hundred and seven patients with primary hypercholesterolemia who required lipid-lowering treatment according to the ATP III guideline were randomized to one of the following six treatments for 8 weeks: fixed-dose combinations with ezetimibe 10 mg daily plus rosuvastatin (5, 10, or 20 mg daily) or rosuvastatin alone (5, 10, or 20 mg daily).

resultsFixed-dose combination of ezetimibe plus rosuvastatin significantly reduced LDL cholesterol, total cholesterol, and triglyceride levels compared with rosuvastatin alone. Depending on the rosuvastatin dose, these fixed-dose combinations of ezetimibe plus rosuvastatin provided LDL cholesterol, total cholesterol, and triglyceride reductions of 56%-63%, 37%-43%, and 19%-24%, respectively. Moreover, the effect of combination treatment on cholesterol levels was more pronounced in patients with DM or MetS than in non-DM or non-MetS patients, respectively, whereas the effect of rosuvastatin alone did not differ between DM vs non-DM or MetS vs non-MetS patients.

conclusionFixed-dose combinations of ezetimibe and rosuvastatin provided significantly superior efficacy to rosuvastatin alone in lowering LDL cholesterol, total cholesterol, and triglyceride levels. Moreover, the reduction rate was greater in patients with DM or MetS.

Indexed as

AgedAnticholesteremic AgentsBiomarkersCholesterol, LDLDiabetes MellitusDouble-Blind MethodDrug CombinationsEzetimibeFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMetabolic SyndromeMiddle AgedRepublic of KoreaAnticholesteremic AgentsBiomarkersCholesterol, LDLDrug CombinationsEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumTriglyceridesCholesterolDiabetes mellitusEzetimibeHypercholesterolemiaMetabolic syndromeRosuvastatin

Identifiers

PMID27506635
PMCPMC5108468
OpenAlexW2498820281

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.