Trial reportClinical cardiology2025

Lipid-Lowering Effect and Safety of Ezetimibe and Atorvastatin 5 mg in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-Blind, Parallel, Multicenter, Phase 3 Clinical Trial.

You-Jeong Ki, Weon Kim, Ki Hong Lee, Sang-Jin Han, Yong-Hyun Kim, Joon-Hyung Doh, Tae Nyun Kim, Choon Hee Chung, Do Young Kim, Jin-Man Cho and 12 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Clinical cardiology, 2025. The graph read 2 numbers from its abstract, feeding 2 cells of the map: it supports the treatment in 2. It reports registered trial NCT05970679. Cited by 1 paper.

2numbers the graph read from it
2cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
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.

← favours the treatmentfavours the comparator →
-47.60 · no effect
LDL-C reductionlow-intensity atorvastatin (5 mg) plus ezetimibe (10 mg) combination therapy (A5E10) vs atorvastatin 5 mg [A5]favours the treatment · dyslipidemiafeeds 2 cells of the map
Δ -47.6<0.0001
The A5E10 group showed significantly greater LDL-C reduction (47.6%) compared with A5 (33.4%), E10 (19.4%), and A10 (40.1%) at 8 weeks (p < 0.0001).

Read, but not usablea number the graph found but could not read as for or against

LDL-C levelslow-intensity atorvastatin (5 mg) plus ezetimibe (10 mg) combination therapy (A5E10)describes a change within one group, not a comparison · dyslipidemiafeeds 2 cells of the map
Δ -46.7
In addition, a significant reduction in LDL-C levels was observed over the 4 weeks, with a 46.7% reduction in LDL-C levels after 4 weeks of A5E10 administration.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Other lipid agents×lipids

SupportsOpen on the map →What to test next →

28 readable studies in this cell: 17 favour the treatment, 2 find no difference, 9 favour the comparator.

Belief with this paper
0.50contested · 17 families support, 6 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper252 enrolled · 2022
Δ -47.6
NCT004793881,216 enrolled · 2007
Δ -4.50-7.70 to -1.30
NCT00862251808 enrolled · 2009
Percent change in least-square means -14.8-19.6 to -9.91
NCT00485758796 enrolled · 2007
Δ -17.9-21.4 to -14.4
NCT00730132712 enrolled · 2008
Δ -5.75-9.43 to -2.07
NCT01763827615 enrolled · 2013
Δ -39.3-43.3 to -35.3
NCT01984424511 enrolled · 2013
Δ -37.8-42.3 to -33.3
NCT06005597407 enrolled · 2024
Least Squares (LS) Means -27.9-37.5 to -18.4
NCT03337308382 enrolled · 2017
Δ -38.0-46.5 to -29.6
NCT02227784366 enrolled · 2014
Δ -6.14-12.2 to -0.22
NCT01763905307 enrolled · 2013
Δ -38.1-43.7 to -33.0
NCT03001076269 enrolled · 2016
Δ -28.4-34.4 to -22.5

Statins×lipids

SupportsOpen on the map →What to test next →

38 readable studies in this cell: 27 favour the treatment, 5 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 21 families support, 7 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper252 enrolled · 2022
Δ -47.6
NCT002899002,340 enrolled · 2006
Δ -13.2-16.8 to -9.60
reduced -66.0-73.0 to -58.0
NCT02546323543 enrolled · 2015
Δ -35.5-40.2 to -30.7
NCT01678820299 enrolled · 2012
Δ 0.50-4.80 to 5.80
NCT01218204287 enrolled · 2010
Δ 5.47-15.7 to 26.7
NCT0093525931 enrolled · 2009
Δ -51.7
reductions -33.6-38.8 to -28.4
4 · 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.

NCT05970679 phase3completed

A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia

Ran2022Enrolled252Registered outcomes4Posted comparisons0ConditionsHypercholesterolemia, DyslipidemiaArmsAtorvastatin 10mg, Atorvastatin 5mg, DW1125A-1 placebo, DW1125A placebo, DW1125E placebo
Open the trial in the graph
5 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

22 authors.

You-Jeong KiCardiovascular Center, Department of Internal Medicine, Uijeongbu Eulji Medical Center, Uijeongbu, Republic of Korea.
Weon KimCardiovascular Division, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.
Ki Hong LeeCardiovascular Division, Department of Internal Medicine, Chonnam National University Medical School & Hospital, Gwangju, Republic of Korea.
Sang-Jin HanDivision of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
Yong-Hyun KimDepartment of Endocrinology, Bundang Jesaeng Hospital, Bundang-gu, Gyeonggido, Republic of Korea.
Joon-Hyung DohInje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Tae Nyun KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
Choon Hee ChungDepartment of Internal Medicine and Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
Do Young KimDivision of Cardiology, Department of Internal Medicine, Ajou University Hospital and Ajou School of Medicine, Suwon, Republic of Korea.
Jin-Man ChoDepartment of Cardiovascular Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
Hyuck-Jun YoonCardiovascular Center, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
In-Kyung JeongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Republic of Korea.
Sungha ParkCardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
Kee-Ho SongDivision of Endocrinology and Metabolism, Konkuk University Medical Center, Konkuk University School of Medicine, Republic of Korea.
Cheol Woong YuDepartment of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-5871-4562
Deok-Kyu ChoYongin Severance Hospital, Yonsei University College of Medicine, Republic of Korea.
Sung Hee ChoiDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-City, Republic of Korea.
Seung-Jin OhDivision of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.
Sanghoon ShinDivision of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea.
Hyeonju JeongDivision of Cardiology, Department of internal medicine, Myongji Hospital, Hanyang University Medical Center, Goyang, Republic of Korea.
Yongwhi ParkDivision of Cardiology, Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea.
Hyo-Soo KimCardiovascular Center, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-0847-5329

Funding

This study was funded by the Daewon Pharmaceutical Co. Ltd.
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectiveThis study aimed to compare the lipid-lowering effect and safety of low-intensity atorvastatin (5 mg) plus ezetimibe (10 mg) combination therapy (A5E10) with monotherapy regimens-atorvastatin 5 mg [A5], ezetimibe 10 mg [E10], and atorvastatin 10 mg [A10])-in dyslipidemia patients.

methodsA randomized, double-blind, placebo-controlled trial involving 252 dyslipidemia patients was conducted at 25 centers in South Korea (NCT05970679). Participants aged ≥ 19 years were randomized into four groups: A5E10, A5, E10, and A10. The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 8 weeks. Secondary endpoints included changes in other lipid parameters, lipid ratios, LDL-C goal achievement rates and safety assessments.

resultsThe mean age of the patients was 63 years, and 51.2% were male. The A5E10 group showed significantly greater LDL-C reduction (47.6%) compared with A5 (33.4%), E10 (19.4%), and A10 (40.1%) at 8 weeks (p < 0.0001). A5E10 also significantly reduced triglyceride, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. In addition, a significant reduction in LDL-C levels was observed over the 4 weeks, with a 46.7% reduction in LDL-C levels after 4 weeks of A5E10 administration. No severe adverse events were observed in the A5E10 group.

conclusionThe combination of low-intensity atorvastatin and ezetimibe was more effective than moderate-intensity atorvastatin monotherapy in lowering LDL-C levels and improving other lipid parameters. It was well-tolerated and demonstrated rapid benefits within a month, offering a promising alternative for patients with low to moderate cardiovascular risk who do not achieve adequate control with statin monotherapy.

Indexed as

Anticholesteremic AgentsAtorvastatinCholesterol, LDLDyslipidemiasEzetimibeHypercholesterolemiaLipidsAdultAgedBiomarkersDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleAnticholesteremic AgentsAtorvastatinBiomarkersCholesterol, LDLEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsatorvastatincholesterolezetimibestatin

Identifiers

PMID40357888
PMCPMC12070249

What Socratic holds

Texttitle and abstract
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 Socratic graph.