Evidence map›Paper›PMID 41553712›Full record

Trial reportAdvances in therapy2026

LDL-C Goal Attainment with Fixed-Dose Ezetimibe and Atorvastatin Versus High-Dose Atorvastatin in Chinese Patients: Subgroup Analysis of a Randomized Trial.

Juying Qian, Xuelian Zhang, Jiyan Chen, Chunhua Ding, Ping Yang, Li Qing, Yan Liu, Si Si Chen, Junbo Ge

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03768427 (A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

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.

NCT03768427 phase3completednot on this map

A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants

TypeinterventionalSponsorOrganon and CoRan2019 to 2021Enrolled454ConditionsHypercholesterolemiaArmsEZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg, Atorvastatin, Placebo for FDC EZ/Ator, Placebo for atorvastatin
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Juying QianDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-7512-3692
Xuelian ZhangDepartment of Cardiology, Jilin Province People's Hospital, Changchun, Jilin, China.ORCID 0009-0000-9696-9745
Jiyan ChenDepartment of Cardiology, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China.ORCID 0000-0003-1216-9316
Chunhua DingCardiac Department, Aerospace Center Hospital, Beijing, China.ORCID 0000-0003-4381-6723
Ping YangDepartment of Cardiology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China.ORCID 0000-0001-7960-6248
Li QingDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0009-0002-3971-1574
Yan LiuMedical Affairs, Organon, Chengdu, Sichuan, China.ORCID 0009-0003-3120-3011
Si Si ChenMedical Affairs and Outcomes Research, Organon (Shanghai) Pharmaceutical Technology Co., Ltd., Shanghai, China.ORCID 0009-0003-0281-0824
Junbo GeDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China. ge.junbo@zs-hospital.sh.cn.ORCID 0000-0001-9640-8171

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCombining ezetimibe (EZ) and statins is recommended for the treatment of elevated low-density lipoprotein-cholesterol (LDL-C). This subgroup analysis evaluated the efficacy of fixed-dose combination (FDC) therapy with EZ and atorvastatin (AS) versus AS monotherapy on attaining LDL-C goals in Chinese patients with very high risk of atherosclerotic cardiovascular disease (ASCVD) grouped by ASCVD risk, age, and sex.

methodsData from the phase III, randomized, double-blind study (NCT03768427) compared EZ10/AS10 mg FDC versus AS20 mg (cohort A), and EZ10/AS20 mg FDC versus AS40 mg monotherapy (cohort B) in Chinese patients with uncontrolled hypercholesterolemia. Proportions of patients attaining 2016 Chinese guideline-recommended LDL-C goals (low/medium risk [< 130 mg/dL], high risk [< 100 mg/dL], very high risk [< 70 mg/dL]) were assessed at weeks 6 and 12. Subgroup analyses by ASCVD risk, age (< 65 and ≥ 65 years), and sex were conducted.

resultsLDL-C goal attainment was significantly higher with FDCs versus AS monotherapy at week 12 (cohort A: 62.7% vs. 35.1%, P = 0.0009; cohort B: 67.5% vs. 31.0%, P < 0.0001). A greater proportion of patients with very high ASCVD risk attained LDL-C goals with FDCs versus AS monotherapy at week 12 (cohort A: 62.3% vs. 33.9%; cohort B: 69.1% vs. 29.5%). LDL-C goal attainment was higher with FDCs versus individual doses of AS at weeks 6 and 12 in both cohorts, regardless of age or sex.

conclusionFDCs significantly improved LDL-C goal attainment compared to AS monotherapy in patients with very high ASCVD risk. In the subgroups by age and sex, a higher proportion of patients with uncontrolled hypercholesterolemia attained their LDL-C goals. TRIAL REGISTRY: Trial registration number NCT03768427.

Indexed as

Anticholesteremic AgentsAtorvastatinCholesterol, LDLEzetimibeHypercholesterolemiaAgedChinaDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedAnticholesteremic AgentsAtorvastatinCholesterol, LDLDrug CombinationsEzetimibeAtherosclerotic cardiovascular diseaseAtorvastatinEzetimibeFixed-dose combinationHypercholesterolemiaLDL-C goal attainmentLipid-lowering therapy

Identifiers

PMID41553712
PMCPMC12999713

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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.