- Drug Regimen
- Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
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Jun Sung Moon, Il Rae Park, Hae Jin Kim, Choon Hee Chung, Kyu Chang Won, Kyung Ah Han, Cheol-Young Park, Jong Chul Won, Dong Jun Kim, Gwan Pyo Koh, Eun Sook Kim, Jae Myung Yu, Eun-Gyoung Hong, Chang Beom Lee, Kun-Ho Yoon
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Diabetes Metab J. 2023;47(6):808-817. Published online September 26, 2023
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DOI: https://doi.org/10.4093/dmj.2022.0387
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- Background
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
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Citations
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- Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study
In‐Kyung Jeong, Kyung Mook Choi, Kyung Ah Han, Kyoung‐Ah Kim, In Joo Kim, Seung Jin Han, Won Young Lee, Soon Jib Yoo Diabetes, Obesity and Metabolism.2024;[Epub] CrossRef
- Drug/Regimen
- Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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Ji Eun Jun, In-Kyung Jeong, Jae Myung Yu, Sung Rae Kim, In Kye Lee, Kyung-Ah Han, Sung Hee Choi, Soo-Kyung Kim, Hyeong Kyu Park, Ji-Oh Mok, Yong-ho Lee, Hyuk-Sang Kwon, So Hun Kim, Ho-Cheol Kang, Sang Ah Lee, Chang Beom Lee, Kyung Mook Choi, Sung-Ho Her, Won Yong Shin, Mi-Seung Shin, Hyo-Suk Ahn, Seung Ho Kang, Jin-Man Cho, Sang-Ho Jo, Tae-Joon Cha, Seok Yeon Kim, Kyung Heon Won, Dong-Bin Kim, Jae Hyuk Lee, Moon-Kyu Lee
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Diabetes Metab J. 2020;44(1):78-90. Published online June 20, 2019
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DOI: https://doi.org/10.4093/dmj.2018.0265
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10,438
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- Background
Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia. MethodsThis randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment. ResultsAfter 8 weeks of treatment, the percent changes from baseline in TG (−29.8% vs. 3.6%, P<0.001) and non-HDL-C (−10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups. ConclusionThe addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.
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- Current trends in solving the problem of residual cardiovascular risk
N. Yu. Obedkova, A. A. Guslyakova, G. S. Mal, E. G. Obedkov Meditsinskiy sovet = Medical Council.2024; (6): 155. CrossRef - Association Between Omega‐3 Fatty Acid Intake and Dyslipidemia: A Continuous Dose–Response Meta‐Analysis of Randomized Controlled Trials
Tianjiao Wang, Xin Zhang, Na Zhou, Yuxuan Shen, Biao Li, Bingshu E. Chen, Xinzhi Li Journal of the American Heart Association.2023;[Epub] CrossRef - Nutraceutical support in the prevention and treatment of cardiovascular diseases
E. V. Gracheva, E. A. Starovoytova, E. S. Kulikov, N. A. Kirillova, S. V. Fedosenko, M. A. Balaganskaya, D. V. Kromka Rational Pharmacotherapy in Cardiology.2023; 19(3): 298. CrossRef - Effect of coadministration of omega-3 fatty acids with glimepiride on glycemic control, lipid profile, irisin, and sirtuin-1 in type 2 diabetes mellitus patients: a randomized controlled trial
Rehab H. Werida, Aalaa Ramzy, Youssri Nassief Ebrahim, Maged Wasfy Helmy BMC Endocrine Disorders.2023;[Epub] CrossRef - The Effect of Dietary Interventions on Hypertriglyceridemia: From Public Health to Molecular Nutrition Evidence
Karla Paulina Luna-Castillo, Xochitl Citlalli Olivares-Ochoa, Rocío Guadalupe Hernández-Ruiz, Iris Monserrat Llamas-Covarrubias, Saraí Citlalic Rodríguez-Reyes, Alejandra Betancourt-Núñez, Barbara Vizmanos, Erika Martínez-López, José Francisco Muñoz-Valle Nutrients.2022; 14(5): 1104. CrossRef - The effect of omega-3 fatty acids and its combination with statins on lipid profile in patients with hypertriglyceridemia: A systematic review and meta-analysis of randomized controlled trials
Yunjiao Yang, Wen Deng, Yanmei Wang, Tongyi Li, Yiding Chen, Cong Long, Qing Wen, Yue Wu, Qiu Chen Frontiers in Nutrition.2022;[Epub] CrossRef - Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week, Multicenter, Random
Jong Shin Woo, Soon Jun Hong, Dong Hoon Cha, Kee Sik Kim, Moo Hyun Kim, Jun-Won Lee, Myung Ho Jeong, Jin-Ok Jeong, Jun-Hee Lee, Doo Soo Jeon, Eun Joo Cho, Soon Kil Kim, Jun Kwan, Chang Gyu Park, Hae Young Lee, Taek Jong Hong, Jinho Shin, Ho Joong Youn, Do Clinical Therapeutics.2021; 43(8): 1419. CrossRef - All-Cause Mortality and Cardiovascular Death between Statins and Omega-3 Supplementation: A Meta-Analysis and Network Meta-Analysis from 55 Randomized Controlled Trials
Jeongseon Kim, Tung Hoang, Ji-Myung Kim, So Young Bu, Jeong-Hwa Choi, Eunju Park, Seung-Min Lee, Eunmi Park, Ji Yeon Min, In Seok Lee, So Young Youn, Jee-Young Yeon Nutrients.2020; 12(10): 3203. CrossRef
- Epidemiology
- Glycosylated Hemoglobin Threshold for Predicting Diabetes and Prediabetes from the Fifth Korea National Health and Nutrition Examination Survey
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Sangmo Hong, Jun Goo Kang, Chul Sik Kim, Seong Jin Lee, Cheol-Young Park, Chang Beom Lee, Sung-Hee Ihm
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Diabetes Metab J. 2016;40(2):167-170. Published online April 5, 2016
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DOI: https://doi.org/10.4093/dmj.2016.40.2.167
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We aimed to estimate the threshold level of glycosylated hemoglobin (HbA1c) for the fasting plasma glucose of 100 and 126 mg/dL in the Korean adult population, using the 2011 Korea National Health and Nutrition Examination Survey. A total of 4,481 participants over 19 years of age without diabetic medications and conditions to influence the interpretation of HbA1c levels, such as anemia, renal insufficiency, liver cirrhosis, and cancers, were analyzed. A point-wise area under the receiver operating characteristic curve was used to estimate the optimal HbA1c cutoff value. A HbA1c threshold of 6.35% was optimal for predicting diabetes with a sensitivity of 86.9% and a specificity of 99.1%. Furthermore, the threshold of HbA1c was 5.65% for prediabetes, with a sensitivity of 69.3% and a specificity of 71%. Further prospective studies are needed to evaluate the HbA1c cutoff point for diagnosing prediabetes and diabetes in the Korean population.
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Citations
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- The Cutoff Value of HbA1c in Predicting Diabetes and Impaired Fasting Glucose
Seyoung Kwon, Youngak Na The Korean Journal of Clinical Laboratory Science.2017; 49(2): 114. CrossRef - Cutoff Point of HbA1c for Diagnosis of Diabetes Mellitus in Chinese Individuals
Bing Wang, Ming-Chuan Liu, Xin-Yu Li, Xu-Han Liu, Qiu-Xia Feng, Lu Lu, Zhu Zhu, Ying-Shu Liu, Wei Zhao, Zheng-Nan Gao, Noel Christopher Barengo PLOS ONE.2016; 11(11): e0166597. CrossRef
- Serum Adiponectin and Type 2 Diabetes: A 6-Year Follow-Up Cohort Study
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Sun Ha Jee, Chul Woo Ahn, Jong Suk Park, Chang Gyu Park, Hyon-Suk Kim, Sang-Hak Lee, Sungha Park, Myoungsook Lee, Chang Beom Lee, Hye Soon Park, Heejin Kimm, Sung Hee Choi, Jidong Sung, Seungjoon Oh, Hyojee Joung, Sung Rae Kim, Ho-Joong Youn, Sun Mi Kim, Hong Soo Lee, Yejin Mok, Eunmi Choi, Young Duk Yun, Soo-Jin Baek, Jaeseong Jo, Kap Bum Huh
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Diabetes Metab J. 2013;37(4):252-261. Published online August 14, 2013
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DOI: https://doi.org/10.4093/dmj.2013.37.4.252
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5,760
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- Background
Studies on factors which may predict the risk of diabetes are scarce. This prospective cohort study was conducted to determine the association between adiponectin and type 2 diabetes among Korean men and women. MethodsA total of 42,845 participants who visited one of seven health examination centers located in Seoul and Gyeonggi province, Republic of Korea between 2004 and 2008 were included in this study. The incidence rates of diabetes were determined through December 2011. To evaluate the effects of adiponectin on type 2 diabetes, the Cox proportional hazard model was used. ResultsOf the 40,005 participants, 959 developed type 2 diabetes during a 6-year follow-up. After the adjustment for age, body mass index (BMI), and waist circumference, the risks for type 2 diabetes in participants with normoglycemia had a 1.70-fold (95% confidence interval [CI], 1.21 to 2.38) increase in men and a 1.83-fold (95% CI, 1.17 to 2.86) increase in women with the lowest tertile of adiponectin when compared to the highest tertile of adiponectin. For participants with impaired fasting glucose (IFG), the risk for type 2 diabetes had a 1.46-fold (95% CI, 1.17 to 1.83) increase in men and a 2.52-fold (95% CI, 1.57 to 4.06) increase in women with the lowest tertile of adiponectin. Except for female participants with normoglycemia, all the risks remained significant after the adjustment for fasting glucose and other confounding variables. Surprisingly, BMI and waist circumference were not predictors of type 2 diabetes in men or women with IFG after adjustment for fasting glucose and other confounders. ConclusionA strong association between adiponectin and diabetes was observed. The use of adiponectin as a predictor of type 2 diabetes is considered to be useful.
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- Adiponectin and metabolic cardiovascular diseases: Therapeutic opportunities and challenges
Xiaotian Lei, Sheng Qiu, Gangyi Yang, Qinan Wu Genes & Diseases.2023; 10(4): 1525. CrossRef - Low levels of total and high-molecular-weight adiponectin may predict non-alcoholic fatty liver in Korean adults
Young-Sang Kim, Soo-Hyun Lee, Seung Geon Park, Bo Youn Won, Hyejin Chun, Doo-Yeoun Cho, Moon-Jong Kim, Ji Eun Lee, Ji-Hee Haam, Kunhee Han Metabolism.2020; 103: 154026. CrossRef - Anti-inflammatory effects of sucrose-derived oligosaccharides produced by a constitutive mutant L. mesenteroides B-512FMCM dextransucrase in high fat diet-fed mice
Min-Gyung Kang, Hee Jae Lee, Jae-Young Cho, Kanghwa Kim, Soo Jin Yang, Doman Kim Biochemical and Biophysical Research Communications.2016; 477(3): 350. CrossRef - Adiponectin as a Protective Factor Against the Progression Toward Type 2 Diabetes Mellitus in Postmenopausal Women
Hossein Darabi, Alireza Raeisi, Mohammad Reza Kalantarhormozi, Afshin Ostovar, Majid Assadi, Kamyar Asadipooya, Katayoun Vahdat, Sina Dobaradaran, Iraj Nabipour Medicine.2015; 94(33): e1347. CrossRef - Effect of ketotifen in obese patients with type 2 diabetes mellitus
Sahar M. El-Haggar, Wael F. Farrag, Fedaa A. Kotkata Journal of Diabetes and its Complications.2015; 29(3): 427. CrossRef - Smoking and Diabetes: Is the Association Mediated by Adiponectin, Leptin, or C-reactive Protein?
Esayas Haregot Hilawe, Hiroshi Yatsuya, Yuanying Li, Mayu Uemura, Chaochen Wang, Chifa Chiang, Hideaki Toyoshima, Koji Tamakoshi, Yan Zhang, Nobuo Kawazoe, Atsuko Aoyama Journal of Epidemiology.2015; 25(2): 99. CrossRef - Association between the level of circulating adiponectin and prediabetes: A meta‐analysis
Huasheng Lai, Nie Lin, Zhenzhen Xing, Huanhuan Weng, Hua Zhang Journal of Diabetes Investigation.2015; 6(4): 416. CrossRef - Adiponectin as a Biomarker of Osteoporosis in Postmenopausal Women: Controversies
Anna Lubkowska, Aleksandra Dobek, Jan Mieszkowski, Wojciech Garczynski, Dariusz Chlubek Disease Markers.2014; 2014: 1. CrossRef - Modulation of adiponectin as a potential therapeutic strategy
Soo Lim, Michael J. Quon, Kwang Kon Koh Atherosclerosis.2014; 233(2): 721. CrossRef
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