Endocrinology and Metabolism

Review Article

Obesity and Metabolism
Role of PCSK9 Inhibitors in Patients with Familial Hypercholesterolemia: Brian Tomlinson, Nivritti Gajanan Patil, Manson Fok, Christopher Wai Kei Lam; Endocrinol Metab. 2021;36(2):279-295. Published online April 19, 2021; DOI: https://doi.org/10.3803/EnM.2021.964

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Patients with familial hypercholesterolemia (FH) are at high or very high risk for cardiovascular disease. Those with heterozygous FH (HeFH) often do not reach low-density lipoprotein cholesterol (LDL-C) targets with statin and ezetimibe therapy, and those with homozygous FH (HoFH) usually require additional lipid-modifying therapies. Drugs that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) offer a novel approach to reduce LDL-C. The monoclonal antibodies, alirocumab and evolocumab, given by subcutaneous injection every 2 or 4 weeks produce reductions in LDL-C of 50% to 60% in patients with HeFH, allowing many of them to achieve their LDL-C goals. Patients with HoFH show a reduced and more variable LDL-C response, which appears to depend on residual LDL receptor activity, and those with receptor-negative mutations may show no response. Inclisiran is a long-acting small interfering RNA therapeutic agent that inhibits the synthesis of PCSK9. Subcutaneous doses of 300 mg can reduce LDL-C by more than 50% for at least 6 months and the responses in HeFH and HoFH patients are similar to those achieved with monoclonal antibodies. These PCSK9 inhibitors are generally well tolerated and they provide a new opportunity for effective treatment for the majority of patients with FH.

Citations

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Phenotypic homozygous familial hypercholesterolemia successfully treated with proprotein convertase subtilisin/kexin type 9 inhibitors
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Targeting Lipoprotein(a): Can RNA Therapeutics Provide the Next Step in the Prevention of Cardiovascular Disease?
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Cardiology and Therapy.2024; 13(1): 39. CrossRef
Technologies of gene editing and related clinical trials for the treatment of genetic and acquired diseases: a systematic review
Wessam Sharaf-Eldin
Egyptian Journal of Medical Human Genetics.2024;[Epub] CrossRef
Qualitative and Quantitative Effects of PCSK9 Inhibitors in familial Hypercholesterolemia: a Synthetic Review
Aamina Shakir, Kyle Barron, Kalgi Modi
Current Problems in Cardiology.2023; 48(4): 101550. CrossRef
Inhibition of PCSK9 Improves the Development of Pulmonary Arterial Hypertension Via Down-Regulating Notch3 Expression
Peng Ye, Xiao-Min Jiang, Wei-Chun Qian, Juan Zhang
Cardiovascular Drugs and Therapy.2023;[Epub] CrossRef
Barriers and shortcomings in access to cardiovascular management and prevention for familial hypercholesterolemia during the COVID‐19 pandemic
Helen Huang, Keith S. K. Leung, Tulika Garg, Adele Mazzoleni, Goshen D. Miteu, Farida Zakariya, Wireko A. Awuah, Elaine T. S. Yin, Faaraea Haroon, Zarish Hussain, Narjiss Aji, Vikash Jaiswal, Gary Tse
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Familial Hypercholesterolemia in Children. The Current State of the Problem
Dinara I. Sadykova, Karina R. Salakhova, Liliya F. Galimova, Eugeniya S. Slastnikova, Chulpan D. Khaliullina
Current Pediatrics.2023; 22(3): 231. CrossRef
Long-term safety and effectiveness of alirocumab and evolocumab in familial hypercholesterolemia (FH) in Belgium
Marc Snel, Olivier S. Descamps
Acta Cardiologica.2023; : 1. CrossRef
PCSK9 inhibitors revisited: Effectiveness and safety of PCSK9 inhibitors in a real-life Spanish cohort
Juan Vicente-Valor, Xandra García-González, Sara Ibáñez-García, María Esther Durán-García, Ana de Lorenzo-Pinto, Carmen Rodríguez-González, Irene Méndez-Fernández, Juan Carlos Percovich-Hualpa, Ana Herranz-Alonso, María Sanjurjo-Sáez
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Development of small-molecule PCSK9 inhibitors for the treatment of hypercholesterolemia
Shakir Ahamad, Shintu Mathew, Waqas A. Khan, Kishor Mohanan
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The biological relevance of PCSK9: when less is better…
Majambu Mbikay, Michel Chrétien
Biochemistry and Cell Biology.2022; 100(3): 189. CrossRef
Fenofibrate add-on to statin treatment is associated with low all-cause death and cardiovascular disease in the general population with high triglyceride levels
Kyung-Soo Kim, Sangmo Hong, Kyungdo Han, Cheol-Young Park
Metabolism.2022; 137: 155327. CrossRef
Homozygous Familial Hypercholesterolemia
Lisa Young, Emily E. Brown, Seth S. Martin
JACC: Case Reports.2022; 4(23): 101666. CrossRef
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Kristina Zubielienė, Gintarė Valterytė, Neda Jonaitienė, Diana Žaliaduonytė, Vytautas Zabiela
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Eric Bruckert, Sonia Caprio, Albert Wiegman, Min-Ji Charng, Cézar A. Zárate-Morales, Marie T. Baccara-Dinet, Garen Manvelian, Anne Ourliac, Michel Scemama, Stephen R. Daniels
Arteriosclerosis, Thrombosis, and Vascular Biology.2022; 42(12): 1447. CrossRef

Original Articles

Clinical Study
Achievement of LDL-C Targets Defined by ESC/EAS (2011) Guidelines in Risk-Stratified Korean Patients with Dyslipidemia Receiving Lipid-Modifying Treatments: Ye Seul Yang, Seo Young Lee, Jung-Sun Kim, Kyung Mook Choi, Kang Wook Lee, Sang-Chol Lee, Jung Rae Cho, Seung-Jin Oh, Ji-Hyun Kim, Sung Hee Choi; Endocrinol Metab. 2020;35(2):367-376. Published online June 24, 2020; DOI: https://doi.org/10.3803/EnM.2020.35.2.367

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Background
This study assessed the proportion of risk-stratified Korean patients with dyslipidemia achieving their low-density lipoprotein cholesterol (LDL-C) targets as defined by the European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) (2011) guidelines while receiving lipid-modifying treatments (LMTs).
Methods
In this multicenter, cross-sectional, observational study, we evaluated data from Korean patients aged ≥19 years who were receiving LMTs for ≥3 months and had an LDL-C value within the previous 12 months on the same LMT. Data were collected for demographics, cardiovascular (CV) risk factors, medical history, and healthcare consumption. Patients were risk-stratified according to the ESC Systematic COronary Risk Evaluation (SCORE) chart and LDL-C target achievement rate was assessed.
Results
Guideline-based risk-stratification of the 1,034 patients showed the majority (72.2%) to be in the very high-risk category. Investigators’ assessment of risk was underestimated in 71.6% compared to ESC/EAS guidelines. Overall LDL-C target achievement rate was 44.3%; target achievement was the highest (66.0%) in moderate-risk patients and the lowest (39.0%) in very high-risk patients. Overall 97.1% patients were receiving statin therapy, mostly as a single-agent (89.2%). High-intensity statins and the highest permissible dose of high-intensity statins had been prescribed to only 9.1% and 7.3% patients in the very high-risk group, respectively. Physician satisfaction with patients’ LDL-C levels was the primary reason for non-intensification of statin therapy.
Conclusion
Achievement of target LDL-C level is suboptimal in Korean patients with dyslipidemia, especially in those at very high-risk of CV events. Current practices in LMTs need to be improved based on precise CV risk evaluation posed by dyslipidemia.

Citations

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Lipid Management in Korean People With Type 2 Diabetes Mellitus: Korean Diabetes Association and Korean Society of Lipid and Atherosclerosis Consensus Statement
Ye Seul Yang, Hack-Lyoung Kim, Sang-Hyun Kim, Min Kyong Moon
Journal of Lipid and Atherosclerosis.2023; 12(1): 12. CrossRef
Lipid Management in Korean People with Type 2 Diabetes Mellitus: Korean Diabetes Association and Korean Society of Lipid and Atherosclerosis Consensus Statement
Ye Seul Yang, Hack-Lyoung Kim, Sang-Hyun Kim, Min Kyong Moon
Diabetes & Metabolism Journal.2023; 47(1): 1. CrossRef
Bempedoic Acid for Lipid Management in the Indian Population: An Expert Opinion
Jagdish Hiremath, J C Mohan, Prakash Hazra, JP S Sawhney, Ashwani Mehta, Sadanand Shetty, Abraham Oomman, Mahesh K Shah, Ganapathi Bantwal, Rajeev Agarwal, Rajiv Karnik, Peeyush Jain, Saumitra Ray, Sambit Das, Vibhuti Jadhao, Sachin Suryawanshi, Hanmant B
Cureus.2023;[Epub] CrossRef
Optimal implementation of the 2019 ESC/EAS dyslipidaemia guidelines in patients with and without atherosclerotic cardiovascular disease across Europe: a simulation based on the DA VINCI study
Julia Brandts, Sarah Bray, Guillermo Villa, Alberico L. Catapano, Neil R. Poulter, Antonio J. Vallejo-Vaz, Kausik K. Ray
The Lancet Regional Health - Europe.2023; 31: 100665. CrossRef
Management of Dyslipidemia in Patients with Diabetes Mellitus
Kyung Ae Lee
The Journal of Korean Diabetes.2023; 24(3): 111. CrossRef
Target Low-Density Lipoprotein-Cholesterol and Secondary Prevention for Patients with Acute Myocardial Infarction: A Korean Nationwide Cohort Study
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Journal of Clinical Medicine.2022; 11(9): 2650. CrossRef
Current Status of Low-Density Lipoprotein Cholesterol Target Achievement in Patients with Type 2 Diabetes Mellitus in Korea Compared with Recent Guidelines
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Obesity and Metabolism
Comparison of the Effects of Ezetimibe-Statin Combination Therapy on Major Adverse Cardiovascular Events in Patients with and without Diabetes: A Meta-Analysis: Namki Hong, Yong-ho Lee, Kenichi Tsujita, Jorge A. Gonzalez, Christopher M. Kramer, Tomas Kovarnik, George N. Kouvelos, Hiromichi Suzuki, Kyungdo Han, Chan Joo Lee, Sung Ha Park, Byung-Wan Lee, Bong-Soo Cha, Eun Seok Kang; Endocrinol Metab. 2018;33(2):219-227. Published online May 4, 2018; DOI: https://doi.org/10.3803/EnM.2018.33.2.219

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Background

Ezetimibe-statin combination therapy has been found to reduce low density lipoprotein cholesterol levels and the risk of major adverse cardiovascular events (MACEs) in large trials. We sought to examine the differential effect of ezetimibe on MACEs when added to statins according to the presence of diabetes.

Methods

Randomized clinical trials with a sample size of at least 50 participants and at least 24 weeks of follow-up that compared ezetimibe-statin combination therapy with a statin- or placebo-controlled arm and reported at least one MACE, stratified by diabetes status, were included in the meta-analysis and meta-regression.

Results

A total of seven trials with 28,191 enrolled patients (mean age, 63.6 years; 75.1% men; 7,298 with diabetes [25.9%]; mean follow-up, 5 years) were analysed. MACEs stratified by diabetes were obtained from the published data (two trials) or through direct contact (five trials). No significant heterogeneity was observed among studies (I²=14.7%, P=0.293). Ezetimibe was associated with a greater reduction of MACE risk in subjects with diabetes than in those without diabetes (pooled relative risk, 0.84 vs. 0.93; P_{heterogeneity}=0.012). In the meta-regression analysis, the presence of diabetes was associated with a greater reduction of MACE risk when ezetimibe was added to statins (β=0.87, P=0.038).

Conclusion

Ezetimibe-statin combination therapy was associated with greater cardiovascular benefits in patients with diabetes than in those without diabetes. Our findings suggest that ezetimibe-statin combination therapy might be a useful strategy in patients with diabetes at a residual risk of MACEs.

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Comparative Efficacy of Rosuvastatin Monotherapy and Rosuvastatin/Ezetimibe Combination Therapy on Insulin Sensitivity and Vascular Inflammatory Response in Patients with Type 2 Diabetes Mellitus
Ji Hye Han, Kyong Hye Joung, Jun Choul Lee, Ok Soon Kim, Sorim Choung, Ji Min Kim, Yea Eun Kang, Hyon-Seung Yi, Ju Hee Lee, Bon Jeong Ku, Hyun Jin Kim
Diabetes & Metabolism Journal.2024; 48(1): 112. CrossRef
Combining Ezetimibe and Rosuvastatin: Impacts on Insulin Sensitivity and Vascular Inflammation in Patients with Type 2 Diabetes Mellitus
Eun Roh
Diabetes & Metabolism Journal.2024; 48(1): 55. CrossRef
Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial
Kenichi Tsujita, Koutaro Yokote, Junya Ako, Ryohei Tanigawa, Sachiko Tajima, Hideki Suganami
Journal of Atherosclerosis and Thrombosis.2023; 30(11): 1580. CrossRef
2023 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association
Jong Han Choi, Kyung Ae Lee, Joon Ho Moon, Suk Chon, Dae Jung Kim, Hyun Jin Kim, Nan Hee Kim, Ji A Seo, Mee Kyoung Kim, Jeong Hyun Lim, YoonJu Song, Ye Seul Yang, Jae Hyeon Kim, You-Bin Lee, Junghyun Noh, Kyu Yeon Hur, Jong Suk Park, Sang Youl Rhee, Hae J
Diabetes & Metabolism Journal.2023; 47(5): 575. CrossRef
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Yongin Cho, Hyungjin Rhee, Young-eun Kim, Minyoung Lee, Byung-Wan Lee, Eun Seok Kang, Bong-Soo Cha, Jin-Young Choi, Yong-ho Lee
BMC Medicine.2022;[Epub] CrossRef
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Development of Clinical Data Mart of HMG-CoA Reductase Inhibitor for Varied Clinical Research: Hun-Sung Kim, Hyunah Kim, Yoo Jin Jeong, Tong Min Kim, So Jung Yang, Sun Jung Baik, Seung-Hwan Lee, Jae Hyoung Cho, In Young Choi, Kun-Ho Yoon; Endocrinol Metab. 2017;32(1):90-98. Published online February 28, 2017; DOI: https://doi.org/10.3803/EnM.2017.32.1.90

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Background

The increasing use of electronic medical record (EMR) systems for documenting clinical medical data has led to EMR data being increasingly accessed for clinical trials. In this study, a database of patients who were prescribed statins for the first time was developed using EMR data. A clinical data mart (CDM) was developed for cohort study researchers.

Methods

Seoul St. Mary's Hospital implemented a clinical data warehouse (CDW) of data for ~2.8 million patients, 47 million prescription events, and laboratory results for 150 million cases. We developed a research database from a subset of the data on the basis of a study protocol. Data for patients who were prescribed a statin for the first time (between the period from January 1, 2009 to December 31, 2015), including personal data, laboratory data, diagnoses, and medications, were extracted.

Results

We extracted initial clinical data of statin from a CDW that was established to support clinical studies; the data was refined through a data quality management process. Data for 21,368 patients who were prescribed statins for the first time were extracted. We extracted data every 3 months for a period of 1 year. A total of 17 different statins were extracted. It was found that statins were first prescribed by the endocrinology department in most cases (69%, 14,865/21,368).

Conclusion

Study researchers can use our CDM for statins. Our EMR data for statins is useful for investigating the effectiveness of treatments and exploring new information on statins. Using EMR is advantageous for compiling an adequate study cohort in a short period.

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Review Article

Update on Familial Hypercholesterolemia: Diagnosis, Cardiovascular Risk, and Novel Therapeutics: Sang-Hak Lee; Endocrinol Metab. 2017;32(1):36-40. Published online January 19, 2017; DOI: https://doi.org/10.3803/EnM.2017.32.1.36

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In recent studies, the reported prevalence of heterozygous familial hypercholesterolemia (FH) has been higher than in previous reports. Although cascade genetic screening is a good option for efficient identification of affected patients, diagnosis using only clinical criteria is more common in real clinical practice. Cardiovascular risk is much higher in FH patients due to longstanding low density lipoprotein cholesterol (LDL-C) burden and is also influenced by other risk factors. Although guidelines emphasize aggressive LDL-C reduction, the majority of patients cannot reach the LDL-C goal by conventional pharmacotherapy. Novel therapeutics such as proprotein convertase subtilisin/kexin type 9 inhibitors have shown strong lipid lowering efficacy and are expected to improve treatment results in FH patients.

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