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Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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
Diabetes Metab J. 2020;44(1):78-90.   Published online June 20, 2019
DOI: https://doi.org/10.4093/dmj.2018.0265
  • 9,124 View
  • 185 Download
  • 7 Web of Science
  • 7 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   
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.

Methods

This 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.

Results

After 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.

Conclusion

The 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.

Citations

Citations to this article as recorded by  
  • 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
Review
Clinical Diabetes & Therapeutics
Effects of Omega-3 Supplementation on Adipocytokines in Prediabetes and Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Randomized Controlled Trials
Tarik Becic, Christian Studenik
Diabetes Metab J. 2018;42(2):101-116.   Published online April 19, 2018
DOI: https://doi.org/10.4093/dmj.2018.42.2.101
  • 7,813 View
  • 60 Download
  • 16 Web of Science
  • 17 Crossref
AbstractAbstract PDFPubReader   
Background

The objective of this systematic review and meta-analysis was to determine the effects of omega-3 supplementation on adipocytokine levels in adult prediabetic and diabetic individuals.

Methods

We searched PubMed, Medline, EMBASE, Scopus, Web of Science, Google Scholar, Cochrane Trial Register, World Health Organization Clinical Trial Registry Platform, and Clinicaltrial.gov Registry from inception to August 1, 2017 for randomized controlled trials. Pooled effects of interventions were assessed as mean difference using random effects model. We conducted a sensitivity, publication bias and subgroup analysis.

Results

Fourteen studies individuals (n=685) were included in the meta-analysis. Omega-3 supplementation increased levels of adiponectin (0.48 µg/mL; 95% confidence interval [CI], 0.27 to 0.68; P<0.00001, n=10 trials), but effects disappeared after sensitivity analysis. Tumor necrosis factor α (TNF-α) levels were reduced (−1.71; 95% CI, −3.38 to −0.14; P=0.03, n=8 trials). Treatment duration shorter than 12 weeks was associated with greater reduction than longer treatment duration. Levels of other adipocytokines were not significantly affected. Publication bias could generally not be excluded.

Conclusion

Eicosapentaenoic acid and docosahexaenoic acid supplementation may increase adiponectin and reduce TNF-α levels in this population group. However, due to overall study heterogeneity and potential publication bias, a cautious interpretation is needed.

Citations

Citations to this article as recorded by  
  • The Effects of Omega-3 Fatty Acid Supplementation on the Lipid Profile and Cardiovascular Markers Following Downhill Running in Long-Distance Runners
    Marzena Jaworska, Szymon Siatkowski, Aleksandra Żebrowska
    Journal of Human Kinetics.2023; 89: 123.     CrossRef
  • Omega-3 supplementation in the treatment of polycystic ovary syndrome (PCOS) – a review of clinical trials and cohort
    Vitoria Melo, Thomas Silva, Thaissa Silva, Juliana Freitas, Joselita Sacramento, Mirian Vazquez, Edilene Araujo
    Endocrine Regulations.2022; 56(1): 66.     CrossRef
  • The effects of omega-3 fatty acids in type 2 diabetes: A systematic review and meta-analysis
    Yanan Xiao, Qifang Zhang, Xueling Liao, Ulf Elbelt, Karsten H. Weylandt
    Prostaglandins, Leukotrienes and Essential Fatty Acids.2022; 182: 102456.     CrossRef
  • Anti-inflammatory and antioxidant activity of astragalus polysaccharide in ulcerative colitis: A systematic review and meta-analysis of animal studies
    Heng-Chang Hu, Wei Zhang, Pei-Yu Xiong, Li Song, Bo Jia, Xing-Long Liu
    Frontiers in Pharmacology.2022;[Epub]     CrossRef
  • Eicosopenthaenoic acid: Gnawing at the perivascular adipose tissue
    Paolo Raggi, Arthur E. Stillman
    Atherosclerosis.2021; 316: 69.     CrossRef
  • The Effect of Omega-3 Fatty Acid Supplementation on Serum Adipocytokines, Lipid Profile and Biochemical Markers of Inflammation in Recreational Runners
    Aleksandra Żebrowska, Barbara Hall, Anna Stolecka-Warzecha, Arkadiusz Stanula, Ewa Sadowska-Krępa
    Nutrients.2021; 13(2): 456.     CrossRef
  • The Influence of Nutrition on Adiponectin—A Narrative Review
    Justyna Janiszewska, Joanna Ostrowska, Dorota Szostak-Węgierek
    Nutrients.2021; 13(5): 1394.     CrossRef
  • Adiponectin’s roles in lipid and glucose metabolism modulation in fish: Mechanisms and perspectives
    Renlei Ji, Xiang Xu, Giovanni M. Turchini, Kangsen Mai, Qinghui Ai
    Reviews in Aquaculture.2021; 13(4): 2305.     CrossRef
  • Omega-3 Fatty Acids and Vulnerability to Addiction: Reviewing Preclinical and Clinical Evidence
    Valerie L. Darcey, Katherine M. Serafine
    Current Pharmaceutical Design.2020; 26(20): 2385.     CrossRef
  • Therapeutic effects of different doses of prebiotic (isolated from Saccharomyces cerevisiae) in comparison to n-3 supplement on glycemic control, lipid profiles and immunological response in diabetic rats
    Janina de Sales Guilarducci, Breno Augusto Ribeiro Marcelino, Isaac Filipe Moreira Konig, Tamira Maria Orlando, Mary Suzan Varaschin, Luciano José Pereira
    Diabetology & Metabolic Syndrome.2020;[Epub]     CrossRef
  • Endothelial dysfunction in neuroprogressive disorders—causes and suggested treatments
    Gerwyn Morris, Basant K. Puri, Lisa Olive, Andre Carvalho, Michael Berk, Ken Walder, Lise Tuset Gustad, Michael Maes
    BMC Medicine.2020;[Epub]     CrossRef
  • Evaluation of walking exercise on glycemic control in patients with type 2 diabetes mellitus
    Hengchang Hu, Yuanhong Lei, Liping Yin, Xiaoqiong Luo
    Medicine.2020; 99(47): e22735.     CrossRef
  • Omega-3 polyunsaturated fatty acids in supporting pregnancy and fetal development: dosing considerations
    Olga A. Gromova, Ivan Iu. Torshin, Tatiana R. Grishina, Svetlana I. Maliavskaia
    Gynecology.2020; 22(5): 61.     CrossRef
  • A Significant Association Between Rhein and Diabetic Nephropathy in Animals: A Systematic Review and Meta-Analysis
    Heng-Chang Hu, Liu-Tao Zheng, Hai-Yan Yin, Yuan Tao, Xiao-Qiong Luo, Kai-Shan Wei, Li-Ping Yin
    Frontiers in Pharmacology.2019;[Epub]     CrossRef
  • Dietary n-3 polyunsaturated fatty acids, fish intake and healthy ageing
    Esther García-Esquinas, Rosario Ortolá, Jose Ramón Banegas, Esther Lopez-García, Fernando Rodríguez-Artalejo
    International Journal of Epidemiology.2019; 48(6): 1914.     CrossRef
  • Beneficial Effects of Adiponectin on Glucose and Lipid Metabolism and Atherosclerotic Progression: Mechanisms and Perspectives
    Hidekatsu Yanai, Hiroshi Yoshida
    International Journal of Molecular Sciences.2019; 20(5): 1190.     CrossRef
  • Examining the Potential of Developing and Implementing Use of Adiponectin-Targeted Therapeutics for Metabolic and Cardiovascular Diseases
    Ying Liu, Vivian Vu, Gary Sweeney
    Frontiers in Endocrinology.2019;[Epub]     CrossRef
Brief Report
Beneficial Effects of Omega-3 Fatty Acids on Low Density Lipoprotein Particle Size in Patients with Type 2 Diabetes Already under Statin Therapy
Myung Won Lee, Jeong Kyung Park, Jae Won Hong, Kwang Joon Kim, Dong Yeob Shin, Chul Woo Ahn, Young Duk Song, Hong Keun Cho, Seok Won Park, Eun Jig Lee
Diabetes Metab J. 2013;37(3):207-211.   Published online June 14, 2013
DOI: https://doi.org/10.4093/dmj.2013.37.3.207
  • 4,130 View
  • 46 Download
  • 23 Crossref
AbstractAbstract PDFPubReader   

Beyond statin therapy for reducing low density lipoprotein cholesterol (LDL-C), additional therapeutic strategies are required to achieve more optimal reduction in cardiovascular risk among diabetic patients with dyslipidemia. To evaluate the effects and the safety of combined treatment with omega-3 fatty acids and statin in dyslipidemic patients with type 2 diabetes, we conducted a randomized, open-label study in Korea. Patients with persistent hypertriglyceridemia (≥200 mg/dL) while taking statin for at least 6 weeks were eligible. Fifty-one patients were randomized to receive either omega-3 fatty acid 4, 2 g, or no drug for 8 weeks while continuing statin therapy. After 8 weeks of treatment, the mean percentage change of low density lipoprotein (LDL) particle size and triglyceride (TG) level was greater in patients who were prescribed 4 g of omega-3 fatty acid with statin than in patients receiving statin monotherapy (2.8%±3.1% vs. 2.3%±3.6%, P=0.024; -41.0%±24.1% vs. -24.2%±31.9%, P=0.049). Coadministration of omega-3 fatty acids with statin increased LDL particle size and decreased TG level in dyslipidemic patients with type 2 diabetes. The therapy was well tolerated without significant adverse effects.

Citations

Citations to this article as recorded by  
  • Diabetic cardiac autonomic neuropathy: insulin resistance, lipid profile, and omega-3 polyunsaturated fatty acids
    Martin-Yurii Markevich, Volodymyr Segin, Victoria Serhiyenko, Alexandr Serhiyenko
    InterConf.2023; (35(163)): 213.     CrossRef
  • Atherogenic features of the fatty acid profile of erythrocyte membranes of patients with fatty liver disease of mixed genesis
    M. V. Kruchinina, A. V. Belkovets, M. V. Parulikova, A. A. Gromov
    Ateroscleroz.2023; 19(4): 350.     CrossRef
  • Omega-3 supplementation in the treatment of polycystic ovary syndrome (PCOS) – a review of clinical trials and cohort
    Vitoria Melo, Thomas Silva, Thaissa Silva, Juliana Freitas, Joselita Sacramento, Mirian Vazquez, Edilene Araujo
    Endocrine Regulations.2022; 56(1): 66.     CrossRef
  • Nutrigenetics, omega-3 and plasma lipids/lipoproteins/apolipoproteins with evidence evaluation using the GRADE approach: a systematic review
    Justine Keathley, Véronique Garneau, Valérie Marcil, David M Mutch, Julie Robitaille, Iwona Rudkowska, Gabriela Magdalena Sofian, Sophie Desroches, Marie-Claude Vohl
    BMJ Open.2022; 12(2): e054417.     CrossRef
  • N-3 fatty acid supplementation mediates lipid profile, including small dense LDL, when combined with statins: a randomized double blind placebo controlled trial
    Gediz Dogay Us, Sohail Mushtaq
    Lipids in Health and Disease.2022;[Epub]     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
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  • Omega-3 Fatty Acids as Druggable Therapeutics for Neurodegenerative Disorders
    Neha M. Chitre, Nader H. Moniri, Kevin S. Murnane
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    K.A. Balogun, R.S. Randunu, S.K. Cheema
    Prostaglandins, Leukotrienes and Essential Fatty Acids.2014; 91(1-2): 39.     CrossRef
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    Catherine Ouellette, Iwona Rudkowska, Simone Lemieux, Benoit Lamarche, Patrick Couture, Marie-Claude Vohl
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