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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).
Kim, Nam Hoon; Lee, Juneyoung; Chon, Suk; Yu, Jae Myung; Jeong, In-Kyung; Lim, Soo; Kim, Won Jun; Song, Keeho; Cho, Ho Chan; Yu, Hea Min; Kim, Kyoung-Ah; Kim, Sang Soo; Lee, Soon Hee; Kim, Chong Hwa; Kwak, Soo Heon; Lee, Yong-Ho; Chung, Choon Hee; Lee, Sihoon; Jin, Heung Yong; Lee, Jae Hyuk; Koh, Gwanpyo; Kim, Sang-Yong; Kim, Jaetaek; Lee, Ju Hee; Kim, Tae Nyun; Jeon, Hyun Jeong; Lee, Ji Hyun; Jeon, Jae-Han; Yoo, Hye Jin; Kim, Hee Kyung; Park, Hyeong-Kyu; Nam-Goong, Il Seong; Hong, Seongbin; Ahn, Chul Woo; Yu, Ji Hee; Park, Jong Heon; Park, Keun-Gyu; Park, Chan Ho; Joung, Kyong Hye; Ryu, Ohk-Hyun; Park, Keun Yong; Hong, Eun-Gyoung; Cha, Bong-Soo; Won, Kyu Chang; Chung, Yoon-Sok; Kim, Sin Gon.
Afiliación
  • Kim NH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
  • Lee J; Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.
  • Chon S; Department of Endocrinology and Metabolism, Kyung Hee University Hospital, College of Medicine, Kyung Hee University, Seoul, Korea.
  • Yu JM; Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Korea.
  • Jeong IK; Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.
  • Lim S; Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
  • Kim WJ; Division of Endocrinology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
  • Song K; Division of Endocrinology and Metabolism, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
  • Cho HC; Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
  • Yu HM; Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea.
  • Kim KA; Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
  • Kim SS; Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
  • Lee SH; Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
  • Kim CH; Department of Internal Medicine, Bucheon Sejong Hospital, Bucheon, Korea.
  • Kwak SH; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • Lee YH; Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • Chung CH; Department of Internal Medicine, Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • Lee S; Department of Internal Medicine, Gachon University College of Medicine, Incheon, Korea.
  • Jin HY; Division 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.
  • Lee JH; Division of Endocrinology, Department of Internal Medicine, Myongji Hospital, Goyang, Korea.
  • Koh G; Division of Endocrinology and Metabolism, Department of Internal Medicine, Jeju National University College of Medicine, Jeju, Korea.
  • Kim SY; Division of Endocrinology and Metabolism, Chosun University College of Medicine, Gwangju, Korea.
  • Kim J; Division of Endocrinology and Metabolism, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
  • Lee JH; Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
  • Kim TN; Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
  • Jeon HJ; Department of Endocrinology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
  • Lee JH; Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.
  • Jeon JH; Department of Internal Medicine, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
  • Yoo HJ; Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
  • Kim HK; Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
  • Park HK; Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
  • Nam-Goong IS; Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
  • Hong S; Department of Endocrinology and Metabolism, Inha University College of Medicine, Incheon, Korea.
  • Ahn CW; Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • Yu JH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea.
  • Park JH; Big Data Steering Department, National Health Insurance Service, Wonju, Korea.
  • Park KG; Department of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
  • Park CH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine, Busan, Korea.
  • Joung KH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
  • Ryu OH; Division of Endocrinology and Metabolism, College of Medicine, Hallym University, Chuncheon, Korea.
  • Park KY; Department of Endocrinology and Metabolism, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.
  • Hong EG; Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
  • Cha BS; Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • Won KC; Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
  • Chung YS; Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
  • Kim SG; Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Endocrinol Metab (Seoul) ; 2024 08 22.
Article en En | MEDLINE | ID: mdl-39174014
ABSTRACT

Background:

Atherogenic 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.

Methods:

This 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.

Conclusion:

This 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Endocrinol Metab (Seoul) Año: 2024 Tipo del documento: Article Pais de publicación:
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Endocrinol Metab (Seoul) Año: 2024 Tipo del documento: Article Pais de publicación: