Evidence map›Paper›PMID 39174014›Full record

ArticleEndocrinology and metabolism (Seoul, Korea)2024

Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE).

Nam Hoon Kim, Juneyoung Lee, Suk Chon, Jae Myung Yu, In-Kyung Jeong, Soo Lim, Won Jun Kim, Keeho Song, Ho Chan Cho, Hea Min Yu and 36 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Endocrinology and metabolism (Seoul, Korea), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Observational
  2. Review
  3. 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

46 authors.

Nam Hoon KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Juneyoung LeeDepartment of Biostatistics, Korea University College of Medicine, Seoul, Korea.
Suk ChonDepartment of Endocrinology and Metabolism, Kyung Hee University Hospital, College of Medicine, Kyung Hee University, Seoul, Korea.
Jae Myung YuDepartment of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Korea.
In-Kyung JeongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.
Soo LimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Won Jun KimDivision of Endocrinology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
Keeho SongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Ho Chan ChoDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Hea Min YuDepartment of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea.
Kyoung-Ah KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
Sang Soo KimDepartment of Internal Medicine, Pusan National University Hospital, Busan, Korea.
Soon Hee LeeDepartment of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
Chong Hwa KimDepartment of Internal Medicine, Bucheon Sejong Hospital, Bucheon, Korea.
Soo Heon KwakDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Yong-Ho LeeDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Choon Hee ChungDepartment of Internal Medicine, Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, Korea.
Sihoon LeeDepartment of Internal Medicine, Gachon University College of Medicine, Incheon, Korea.
Heung Yong JinDivision of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Clinical Medicine of Jeonbuk National University Medical School-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Korea.
Jae Hyuk LeeDivision of Endocrinology, Department of Internal Medicine, Myongji Hospital, Goyang, Korea.
Gwanpyo KohDivision of Endocrinology and Metabolism, Department of Internal Medicine, Jeju National University College of Medicine, Jeju, Korea.
Sang-Yong KimDivision of Endocrinology and Metabolism, Chosun University College of Medicine, Gwangju, Korea.
Jaetaek KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Ju Hee LeeDepartment of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
Tae Nyun KimDepartment of Internal Medicine, Inje University College of Medicine, Busan, Korea.
Hyun Jeong JeonDepartment of Endocrinology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
Ji Hyun LeeDepartment of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.
Jae-Han JeonDepartment of Internal Medicine, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
Hye Jin YooDivision of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
Hee Kyung KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Hyeong-Kyu ParkDivision of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
Il Seong Nam-GoongDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Seongbin HongDepartment of Endocrinology and Metabolism, Inha University College of Medicine, Incheon, Korea.
Chul Woo AhnDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Ji Hee YuDivision of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea.
Jong Heon ParkBig Data Steering Department, National Health Insurance Service, Wonju, Korea.
Keun-Gyu ParkDepartment of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
Chan Ho ParkDivision of Endocrinology and Metabolism, Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine, Busan, Korea.
Kyong Hye JoungDivision of Endocrinology and Metabolism, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
Ohk-Hyun RyuDivision of Endocrinology and Metabolism, College of Medicine, Hallym University, Chuncheon, Korea.
Keun Yong ParkDepartment of Endocrinology and Metabolism, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.
Eun-Gyoung HongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Bong-Soo ChaDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Kyu Chang WonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Yoon-Sok ChungDepartment of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Sin Gon KimDivision of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.

Funding

Hyundai Pharm
6 · The paper itself

Abstract

backgruoundAtherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.

methodsThis is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.

conclusionThis trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Drug Therapy, CombinationEzetimibeFenofibrateHydroxymethylglutaryl-CoA Reductase InhibitorsAdultAgedAnticholesteremic AgentsDyslipidemiasFemaleHeart Disease Risk FactorsHumansMaleMiddle AgedMulticenter Studies as TopicAnticholesteremic AgentsEzetimibeFenofibrateHydroxymethylglutaryl-CoA Reductase InhibitorsCardiovascular diseasesDiabetes mellitus, type 2DyslipidemiasEzetimibeFibric acidsStatin

Identifiers

PMID39174014
PMCPMC11525705

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.