Diabetes & Metabolism Journal

Review

Drug/Regimen
New, Novel Lipid-Lowering Agents for Reducing Cardiovascular Risk: Beyond Statins: Kyuho Kim, Henry N. Ginsberg, Sung Hee Choi; Diabetes Metab J. 2022;46(4):517-532. Published online July 27, 2022; DOI: https://doi.org/10.4093/dmj.2022.0198; Correction in: Diabetes Metab J 2022;46(5):817

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Statins are the cornerstone of the prevention and treatment of atherosclerotic cardiovascular disease (ASCVD). However, even under optimal statin therapy, a significant residual ASCVD risk remains. Therefore, there has been an unmet clinical need for novel lipid-lowering agents that can target low-density lipoprotein cholesterol (LDL-C) and other atherogenic particles. During the past decade, several drugs have been developed for the treatment of dyslipidemia. Inclisiran, a small interfering RNA that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), shows comparable effects to that of PCSK9 monoclonal antibodies. Bempedoic acid, an ATP citrate lyase inhibitor, is a valuable treatment option for the patients with statin intolerance. Pemafibrate, the first selective peroxisome proliferator-activated receptor alpha modulator, showed a favorable benefit-risk balance in phase 2 trial, but the large clinical phase 3 trial (PROMINENT) was recently stopped for futility based on a late interim analysis. High dose icosapent ethyl, a modified eicosapentaenoic acid preparation, shows cardiovascular benefits. Evinacumab, an angiopoietin-like 3 (ANGPTL3) monoclonal antibody, reduces plasma LDL-C levels in patients with refractory hypercholesterolemia. Novel antisense oligonucleotides targeting apolipoprotein C3 (apoC3), ANGPTL3, and lipoprotein(a) have significantly attenuated the levels of their target molecules with beneficial effects on associated dyslipidemias. Apolipoprotein A1 (apoA1) is considered as a potential treatment to exploit the athero-protective effects of high-density lipoprotein cholesterol (HDL-C), but solid clinical evidence is necessary. In this review, we discuss the mode of action and clinical outcomes of these novel lipid-lowering agents beyond statins.

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Original Articles

Relationship between Plasminogen Activator Inhibitor-1 (PAI-1), Lipoprotein(a) and Diabetic Retinopathy in Type 2 Diabetes Mellitus.: Shin Young Choi, Eun Young Kim, Kyung Won Kim, yu Young Jung, Jung Ho, Young Hun Ku, Hyung Kul Lee, Mi Kyung Kim; Korean Diabetes J. 1999;23(4):552-561. Published online January 1, 2001

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Abstract PDF: BACKGROUND
Diabetic retinopathy is a major cause of visual loss today, especially in diabetic patients having disturbances in hemostasis. Plasma plasminogen activator inhibitor-1 (PAI-1) and lipoprotein (a) may be involved in the pathogenesis of diabetic retinopathy of type 2 diabetes mellitus. This study was undertaken to determine whether plasma PAI-1 and Lp(a) levels are increased in type 2 diabetic patients with retinopathy, and to identify factors influencing PAI-1 and Lp(a) levels. METHODS: A total of 177 type 2 diabetic subjects were classified by the presence or absence of retinopathy, 92 and 85, respectively, and fasting blood samples were taken for assay of PAI-1, Lp(a), creatinine clearance, serum lipid profiles and C-peptide levels. RESULTS: Subjects with retinopathy showed higher levels of PAI-1 (p<0.05), Lp(a) (p<0.01), total cholesterol (p<0.01), triglyceride (p<0.01) and longer disease duration than those without retinopathy. In multiple regression analysis, PAI-1 levels were significantly correlated with high density lipoprotein (HDL) cholesterol, while Lp(a) levels were correlated with body mass index, total cholesterol and low density lipoprotein (LDL) cholesterol. CONCLUSION: These results suggest that elevated PAI-1and Lp(a) are associated with the presence of diabetic retinopathy.

Plasma Concentrations of Plasminogen Activator Inhibitor-1(PAI-1) and Lipoprotein(a) in Non-Insulin-Dependent Diabetes Mellitus with Peripheral Vascular Disease.: Sung Jin Nam, Sung Rae Cho, Choo Sung Kim, Sang Gyun Woo, Hee Jin Choi, Sang Ki Kim, Jae Hong Park, In Kyu Lee, Seong Bum Han, Seung Yup Han, Chung Chul Kim; Korean Diabetes J. 1999;23(1):55-61. Published online January 1, 2001

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Abstract PDF: OBJECTIVES
The plasminogen activator inhibitor-1 (PAI-I) and lipoprotein(a) are considered as important fibrinolysis inhibitors. We evaluated PAI-1 and Lp(a) concentrations in Korean non-insulin- dependent diabetes mellitus (NIDDM) patients with or without peripheral vascular disorder. METHODS: By using National Diabetes Data Group (NDDG) criteria as a diabetes mellitus diagnostic criteria, a total of 127 Korean NIDDM patients were seleeted. The ankle brachial index was measured by segrnental volume plethysmography to diagnose peripheral vascular disease. We also examined clinical and biochemical parameters in NIDDM patients. RESULTS: The duration of diabetes, systolic and diastolic pressures was significantly higher in diabetic patients with peripheral vascular disease (Group 2) than in diabetic patients without peripheal vascular disease (Group 1). The 24 hour urine microalbumin and PAI-1 levels in Group 2 were also significantly higher and the HDL-cholesterol level was lower than in Group 1. There were significant correlations between the plasma level of PAI-1 and BMI (r=0.466, p=0,007) or C-peptide level(r=0.517, p=0.012). Multivariate logistic regression analysis showed that Lp(a) and PAI-1 are independent risk factors for peripheral vascular disease. CONCLUSION: In the light of these results, it seems reasonable to suggest that high levels of PAI-1 and Lp(a) in NlDDM patients may play a role in the pathogenesis of peripheral vascular disease.

High Serum Lipoprotein ( a ) Levels in Korean Type 2 Diabetic Patients with Proliferative Diabetic retinopathy.: Hyung Joo Park, Chul Hee Kim, Yun Ey Chung, Sang Wook Kim, Jin Yub Kim, Eun Sook Kim, Sung Kwan Hong, Ki Up Lee; Korean Diabetes J. 1998;22(3):338-343. Published online January 1, 2001

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Abstract PDF: BACKGROUND
To examine the possible association between serum lipoprotein(a) (Lp(a)) concentration and proliferative diabetic retinopathy(PDR) in Korean patients with type 2 diabetes mellitus. METHODS: A total of 412 Korean outpatients with type 2 diabetes were examined. Diabetic retinopathy was determined by fundoscopic examination by an ophthalmologist and/or by fluorecein angiography. Semm Lp(a) levels were measured by one step sandwich ELISA method. RESULTS: The patient with PDR had higher serum Lp(a) levels than those with no retinopathy or non-proliferative diabetic retinopathy(NPDR). Multiple logistic regression analysis showed that serum Lp(a) level and the presence of diabetic nephropathy were independent variables having a statistically significant association with PDR. CONCLUSION: Korean type 2 diabetic patients with PDR had higher serum Lp(a) levels compared with those with no retinopathy or NPDR. Although these results suggested that Lp(a) might play a role in the occlusion of retinal capillaries leading to PDR, further prospective studies are required to prove causal relationship.

Lipoprotein (a) Level and Vascular Complications in NIDDM.: Ji Youn Kim, Mung Su Kim, Joung Min Kim, Jai Hong Park, Joung Hun Lee, Seung Won Yang, Dong Jin Chung, Min Young Chung, Tai Hee Lee; Korean Diabetes J. 1998;22(1):65-73. Published online January 1, 2001

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Abstract PDF: BACKGROUND
The risk of atherosclerosis is increased in subjects with diabetes mellitus. Lipoprotein(a) [Lp(a)] is an independent risk factor for atherosclerotic vascular disease in subjects without diabetes. The contribution of Lp(a) to the increased risk for atherosclerosis and diabetic complications in subjects with diabetes is not well known. In this report we examined the relationship between Lp(a) levels and development of vascular (macro- and microvascular) complications, and the relationship between Lp(a) and other risk factors for vascular complications in subjects with non-insulin-dependent diabetes mellitus(NIDDM), METHODS: For this study we evaluated 152 patients with NIDDM(72 women and 80 men). Lp(a) level was measured with N-Latex Lp(a) Reagent. Electrocardiography, coronary angiography, brain CT/MRI, doppler velocimetry and peripheral angiography were done for diagnosis of macravascular complieations, and fundus camera, nerve conduction velocity, BBV (beat to beat variation), VPT(vibration perception threshold) and 24-hour urine protein amount were examined for diagnosis of microvascular complications. RESULTS: Lp(a) levels in subjects with ischemic heart disease, cerebrovascular disease and diabetic retinopathy were significantly higher than those in subjects without above mentioned diseases. ApoB/ApoA1 ratio and LDL-cholesterol levels in subjects with Lp(a) level>30mg/dL were significantly higher than those in subjects with Lp(a) level 30mg/dL, and Lp(a) has a positive correlation with ApoB/ApoA1 ratio and LDL-cholesterol in NIDDM patients with vasculopathy. CONCLUSION: These results suggest that high Lp(a) levels seem to be associated with macrovascular and microvascular(especially with retinopathy) complications in subjects with NIDDM and Lp(a) level should be measured in the NIDDM with high level of ApoB/ApoA1 ratio and/or LDL-eholesterol.

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