Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia

Bhatt, Deepak L. and Steg, P. Gabriel and Miller, Michael and Brinton, Eliot A. and Jacobson, Terry A. and Ketchum, Steven B. and Doyle, Ralph T. and Juliano, Rebecca A. and Jiao, Lixia and Granowitz, Craig and Tardif, Jean-Claude and Ballantyne, Christie M. and ..., . and Ukraine, : and Yena, Larysa and Syvolap, Viktor and Kopytsya, Mykola P. and Barna, Olga and Panina, Svitlana S. and Lutai, Mykhailo I. and Shershnyova, Oxana V. and Luzkiv, Iryna and Bula, Larysa S. and Zotov, Sergii and Vyjhovaniuk, Ivan and Lysunets, Olena and Koshlia, Volodymyr I. and Sydor, Nataliya and Vayda, Myroslava F. and Ushakov, Olexiy and Rishko, Mykola and Shcherbak, Viktor P. and Svyshchenko, Yevgeniya and Tseluyko, Vira and Yagensky, Andriy and Zolotaikina, Viktoriia I. and Godlevska, Olga and Ivanova, Larysa and Koval, Olena and Mitchenko, Olena I. and Kardash, Galyna Y. and Rudyk, Yurii S. and Stanislavchuk, Mykola and Volkov, Volodymyr Ivanovych and Karlinskaya, Olena G. and Tykhonova, Susanna A. and Vatutin, Nikolay and Smirnova, Ganna and Kovalenko, Olena Volodymyr M. and Lizogub, Viktor and Sebov, Denys and Dyadyk, Oleksandr and Andrievskaya, Svetlana and Krasko, Mykola P. and Parkhomenko, Alexander N. and Horbach, Lidiya and Kupnovytska, Iryna G. and Pertseva, Tetyana and Karpenko, Oleksandr and Reshotko, Dmytro and Zhurba, Svitlana V. and Rudenko, Leonid and Zharinova, Viktoriia Yu and Shatylo, Valerii B. and Karpenko, Yuriy I. and Orynchak, Mariya A. (2019) Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. The New England Journal of Medicine = N Engl J Med, 380 (1). pp. 11-22. ISSN 0028-4793 (print); 1533-4406 (online)

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Abstract

BACKGROUND Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events. METHODS We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. RESULTS A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001). The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06). CONCLUSIONS Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361.

Item Type:	Article
Subjects:	Internal Medicine Cardiology
Divisions:	Departments > Department of Internal Medicine 1 (formerly - Faculty Therapy and Endocrinology) Departments > Department of Internal Medicine 3 (formerly - hospital therapy 2)
Depositing User:	Елена Шрамко
Date Deposited:	30 Nov 2020 15:08
Last Modified:	01 Dec 2020 15:18
URI:	http://repo.dma.dp.ua/id/eprint/6024

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