Effects of icosapent ethyl on lipid and inflammatory parameters in patients with diabetes mellitus-2, residual elevated triglycerides (200–500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study

Brinton, Eliot A.; Ballantyne, Christie M.; Bays, Harold; Kastelein, John J.P.; Braeckman, René; Soni, Paresh N.

doi:10.1186/1475-2840-12-100

Cited by 66 publications

(51 citation statements)

References 36 publications

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“…The phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week ANCHOR (NCT01047501) study examined the safety and efficacy of IPE in high-risk statin-treated patients with residually high TGs (≥200 and <500 mg/dL) despite statin control of LDL-C (≥40 and ≤115 mg/dL). In a subanalysis of patients with diabetes from the ANCHOR study, IPE 4 g/day significantly decreased median LDL-C by 6.3% ( P = 0.02), TGs by 23.2% ( P < 0.0001), non-HDL-C by 14.4% ( P < 0.0001), TC by 12.7% ( P < 0.0001), and HDL-C by 5.0% ( P < 0.01) compared with placebo [21]. The decreases in LDL-C, TG, non-HDL-C, and TC in the present analysis are consistent with these results, with perhaps somewhat more robust reductions in LDL-C observed in our analysis.…”

Section: Discussionmentioning

confidence: 99%

Retrospective Case Series of Patients with Diabetes or Prediabetes Who Were Switched from Omega-3-Acid Ethyl Esters to Icosapent Ethyl

Hassan¹,

Tajuddin²,

Shaikh³

2014

Cardiol Ther

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IntroductionPatients with diabetes and prediabetes are at increased risk of dyslipidemia and cardiovascular disease. To reduce this risk, statins and additional therapies may be considered. Omega-3 fatty acids offer an option to reduce triglycerides (TG) and potentially improve other lipid parameters, although products that contain docosahexaenoic acid (DHA) may increase low-density lipoprotein cholesterol (LDL-C) while eicosapentaenoic acid (EPA) does not. Prescription formulations include omega-3-acid mixtures (combination of predominantly EPA and DHA), and icosapent ethyl (high-purity prescription form of EPA ethyl ester); prescription omega-3 products are indicated as an adjunct to diet to reduce TGs in adult patients with severe hypertriglyceridemia at a dose of 4 g/day.MethodsThis was a retrospective analysis of records from a private endocrinology practice of patients who received omega-3-acid ethyl esters (OM3EE) (4 g/day) and were subsequently switched to icosapent ethyl (IPE; 4 g/day) due to the potential of OM3EE to raise LDL-C and/or cause gastrointestinal upset. Patient records were analyzed for LDL-C, TG, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and non-HDL-C measured before and after the switch to IPE.ResultsThe records of ten patients met the criteria for this analysis and were included. All patients had taken OM3EE for ≥1 year prior to their last lipid measurement before switching to IPE, and all had been taking IPE for >3 months at the time of their subsequent lipid measurement. Nine of the ten patients were on concomitant statin therapy throughout. Reductions in LDL-C, TC, and non-HDL-C were observed in eight patients, reductions or no changes in TG were observed in eight patients, and increases or no changes in HDL-C were observed in eight patients. No gastrointestinal adverse events were observed.ConclusionIn most patients with prediabetes or diabetes who switched from OM3EE to IPE, LDL-C and other lipid parameters improved. IPE was well tolerated.

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Section: Discussionmentioning

confidence: 99%

Retrospective Case Series of Patients with Diabetes or Prediabetes Who Were Switched from Omega-3-Acid Ethyl Esters to Icosapent Ethyl

Hassan¹,

Tajuddin²,

Shaikh³

2014

Cardiol Ther

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“…Supplemental n-3 polyunsaturated fatty acids (PUFAs), mainly eicosapentaenoic acid and docosahexaenoic acid, are well known to reduce hypertriglyceridemia [147]. In addition to hypotriglyceridemic effects, omega-3 fatty acids may attenuate inflammation, improve endothelial function and reduce thrombus formation [148,149]. However, recent clinical outcome trials with have failed to show significant CV benefits in high risk subjects [150][151][152].…”

Section: Management Of Hypertriglyceridemiamentioning

confidence: 99%

Hypertriglyceridemia: a too long unfairly neglected major cardiovascular risk factor

Tenenbaum

Klempfner

Fisman

2014

Cardiovasc Diabetol

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The existence of an independent association between elevated triglyceride (TG) levels, cardiovascular (CV) risk and mortality has been largely controversial. The main difficulty in isolating the effect of hypertriglyceridemia on CV risk is the fact that elevated triglyceride levels are commonly associated with concomitant changes in high density lipoprotein (HDL), low density lipoprotein (LDL) and other lipoproteins. As a result of this problem and in disregard of the real biological role of TG, its significance as a plausible therapeutic target was unfoundedly underestimated for many years. However, taking epidemiological data together, both moderate and severe hypertriglyceridaemia are associated with a substantially increased long term total mortality and CV risk. Plasma TG levels partially reflect the concentration of the triglyceride-carrying lipoproteins (TRL): very low density lipoprotein (VLDL), chylomicrons and their remnants. Furthermore, hypertriglyceridemia commonly leads to reduction in HDL and increase in atherogenic small dense LDL levels. TG may also stimulate atherogenesis by mechanisms, such excessive free fatty acids (FFA) release, production of proinflammatory cytokines, fibrinogen, coagulation factors and impairment of fibrinolysis. Genetic studies strongly support hypertriglyceridemia and high concentrations of TRL as causal risk factors for CV disease. The most common forms of hypertriglyceridemia are related to overweight and sedentary life style, which in turn lead to insulin resistance, metabolic syndrome (MS) and type 2 diabetes mellitus (T2DM). Intensive lifestyle therapy is the main initial treatment of hypertriglyceridemia. Statins are a cornerstone of the modern lipids-modifying therapy. If the primary goal is to lower TG levels, fibrates (bezafibrate and fenofibrate for monotherapy, and in combination with statin; gemfibrozil only for monotherapy) could be the preferable drugs. Also ezetimibe has mild positive effects in lowering TG. Initial experience with en ezetimibe/fibrates combination seems promising. The recently released IMPROVE-IT Trial is the first to prove that adding a non-statin drug (ezetimibe) to a statin lowers the risk of future CV events. In conclusion, the classical clinical paradigm of lipids-modifying treatment should be changed and high TG should be recognized as an important target for therapy in their own right. Hypertriglyceridemia should be treated.

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“…103 Use of EPA alone in the Marine Trial of 229 patients with TG >500 mg/dL showed a significant lowering of TG levels by 33% without an increase in LDL levels. 104 Although this trial might suggest that EPA does not raise LDL, as was found with other treatments, the selection of a very high baseline TG is not comparable to that of many other trials. Amarin is an omega-3 fatty acid agent containing ≥96% pure icosapentethyl (IPE), the ethyl ester of EPA.…”

Section: What Are the Current Medications?mentioning

confidence: 79%

Triglyceride Treatment in the Age of Cholesterol Reduction

Agrawal

Corradi

Gumaste

et al. 2016

Progress in Cardiovascular Diseases

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Cholesterol reduction has markedly reduced major cardiovascular disease (CVD) events and shown regression of atherosclerosis in some studies. However, CVD has for decades also been associated with increased levels of circulating triglyceride (TG)-rich lipoproteins. Whether this is due to a direct toxic effect of these lipoproteins on arteries or whether this is merely an association is unresolved. More recent genetic analyses have linked genes that modulate TG metabolism with CVD. Moreover, analyses of subgroups of hypertriglyceridemic (HTG) subjects in clinical trials using fibric acid drugs have been interpreted as evidence that TG reduction reduces CVD events. This review will focus on how HTG might cause CVD, whether TG reduction makes a difference, what pathophysiological defects cause HTG, and what options are available for treatment.

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Effects of icosapent ethyl on lipid and inflammatory parameters in patients with diabetes mellitus-2, residual elevated triglycerides (200–500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study

Cited by 66 publications

References 36 publications

Retrospective Case Series of Patients with Diabetes or Prediabetes Who Were Switched from Omega-3-Acid Ethyl Esters to Icosapent Ethyl

Retrospective Case Series of Patients with Diabetes or Prediabetes Who Were Switched from Omega-3-Acid Ethyl Esters to Icosapent Ethyl

Hypertriglyceridemia: a too long unfairly neglected major cardiovascular risk factor

Triglyceride Treatment in the Age of Cholesterol Reduction

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