Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis

Yokoyama, Mitsuhiro; Origasa, Hideki; Matsuzaki, Masunori; Matsuzawa, Yūji; Saitō, Yasushi; Ishikawa, Yuichi; Oikawa, Shinichi; Sasaki, Jun; Hishida, Hitoshi; Itakura, Hiroshige; Kita, Toru; Kitabatake, Akira; Nakaya, Noriaki; Sakata, Toshiie; Shimada, Kazuyuki; Shirato, Kunio

doi:10.1016/s0140-6736(07)60527-3

Cited by 2,148 publications

(1,555 citation statements)

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“…In contrast, among statin nonusers, 9% of those receiving omega‐3 fatty acids had cardiovascular events compared with 18% of those not receiving omega‐3 fatty acids (hazard ratio, 0.46: 95% CI, 0.21–1.01; P =0.051) 25. As noted earlier, the JELIS trial reported that addition of 1800 mg/day of open‐label EPA to low‐intensity statin therapy conferred a significant 19% reduction in major coronary events compared with low‐intensity statin alone, a finding suggesting that high‐dose EPA added to low‐intensity statin therapy can reduce residual risk 4. These findings, coupled with our results, suggest that statin use and dose may be important factors affecting clinical outcomes and plaque volume.…”

Section: Discussionmentioning

confidence: 74%

“…Omega‐3 fatty acids are approved by the US Food and Drug Administration for lowering elevated levels of triglyceride, but their beneficial effect was independent of triglyceride lowering in the JELIS trial4; therefore, other mechanisms need to be explored. The aim of the current study was to determine whether high‐dose, very‐long‐chain omega‐3 polyunsaturated fatty acids—EPA and docosahexaenoic acid (DHA)—conferred additional benefit to statin treatment in preventing progression of coronary plaque volume compared with statin alone in patients with coronary artery disease (CAD).…”

mentioning

confidence: 99%

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Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial

Alfaddagh

Elajami

Ashfaque

et al. 2017

JAHA

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BackgroundAlthough statins reduce cardiovascular events, residual risk remains. Therefore, additional modalities are needed to reduce risk. We evaluated the effect of eicosapentaenoic acid and docosahexaenoic acid in pharmacologic doses added to statin treatment on coronary artery plaque volume.Methods and ResultsA total of 285 subjects with stable coronary artery disease on statins were randomized to omega‐3 ethyl‐ester (1.86 g of eicosapentaenoic acid and 1.5 g of docosahexaenoic acid daily) or no omega‐3 (control) for 30 months. Coronary plaque volume was assessed by coronary computed tomographic angiography. Mean (SD) age was 63.0 (7.7) years; mean low‐density lipoprotein cholesterol ≤80 mg/dL. In the intention‐to‐treat analysis, our primary endpoint, noncalcified plaque volume, was not different between groups (P=0.14) but approached significance in the per protocol analysis (P=0.07). When stratified by age in the intention‐to‐treat analysis, younger omega‐3 subjects had significantly less progression of the primary endpoint, noncalcified plaque (P=0.013), and fibrous, calcified and total plaque. In plaque subtype analysis, controls had significant progression of fibrous plaque compared to no change in the omega‐3 ethyl‐ester group (median % change [interquartile range], 5.0% [−5.7, 20.0] versus −0.1% [−12.3, 14.5], respectively; P=0.018). Among those on low‐intensity statins, omega‐3 ethyl‐ester subjects had attenuation of fibrous plaque progression compared to controls (median % change [interquartile range], 0.3% [−12.8, 9.0] versus 4.8% [−5.1, 19.0], respectively; P=0.032). In contrast, those on high‐intensity statins had no difference in plaque change in either treatment arm.ConclusionsHigh‐dose eicosapentaenoic acid and docosahexaenoic acid provided additional benefit to statins in preventing progression of fibrous coronary plaque in subjects adherent to therapy with well‐controlled low‐density lipoprotein cholesterol levels. The benefit on low‐intensity statin, but not high‐intensity statin, suggests that statin intensity affects plaque volume.Clinical Trial Registration URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01624727.

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Section: Discussionmentioning

confidence: 74%

mentioning

confidence: 99%

Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial

Alfaddagh

Elajami

Ashfaque

et al. 2017

JAHA

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“…Davidson et al (96) found that after treating HC patients with n-3 PUFA and/or simvastatin for 12 weeks, the TAG responses were similar in the EPA/DHA-group (2 25·3 %) and the combined group (2 28·8 %), and borderline significantly lower in the simvastatin group (2 18·5 %), whereas decreases in non-HDL-cholesterol and increases in HDL-cholesterol were statistically significant only for the combined (non-HDL: 2 24·8 %, HDL: þ10·4 %) and simvastatin group (non-HDL: 2 25·8 %, HDL: þ7·2 %). All other studies found significant improvements of TAG with a combination therapy compared with the statin therapy alone (94,95,97,99,104) . Study populations included, besides HC patients, renal transplant patients with persistent hypercholesterolaemia (99) and insulin-resistant obese men with dyslipidaemia (95) .…”

Section: Effects Of Combination Therapy With N-3 Pufa and Statinsmentioning

confidence: 93%

“…This applied in both patients taking statins for primary prevention as for secondary prevention (104) . Few studies have examined the effects of combined treatment of n-3 PUFA and statins in patients with FH.…”

Section: Effects Of Combination Therapy With N-3 Pufa and Statinsmentioning

confidence: 99%

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Support of drug therapy using functional foods and dietary supplements: focus on statin therapy

et al. 2010

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Functional foods and dietary supplements might have a role in supporting drug therapy. These products may (1) have an additive effect to the effect that a drug has in reducing risk factors associated with certain conditions, (2) contribute to improve risk factors associated with the condition, other than the risk factor that the drug is dealing with, or (3) reduce drug-associated side effects, for example, by restoring depleted compounds or by reducing the necessary dose of the drug. Possible advantages compared with a multidrug therapy are lower drug costs, fewer side effects and increased adherence. In the present review we have focused on the support of statin therapy using functional foods or dietary supplements containing plant sterols and/or stanols, soluble dietary fibre, n-3 PUFA or coenzyme Q 10 . We conclude that there is substantial evidence that adding plant sterols and/or stanols to statin therapy further reduces total and LDL-cholesterol by roughly 6 and 10 %, respectively. Adding n-3 PUFA to statin therapy leads to a significant reduction in plasma TAG of at least 15 %. Data are insufficient and not conclusive to recommend the use of soluble fibre or coenzyme Q 10 in patients on statin therapy and more randomised controlled trials towards these combinations are warranted. Aside from the possible beneficial effects from functional foods or dietary supplements on drug therapy, it is important to examine possible (negative) effects from the combination in the long term, for example, in post-marketing surveillance studies. Moreover, it is important to monitor whether the functional foods and dietary supplements are taken in the recommended amounts to induce significant effects. Combination therapy: Dyslipidaemia: Statins: Functional foodsThe world market for functional foods (FF) and dietary supplements (DS) is expanding rapidly. In 2010 FF are expected to represent 5 % of the total global food market (1) and the market for DS is estimated at more than $60 billion worldwide (2) . In general, the target population of FF or DS is healthy individuals with slightly elevated risk factors or some physical discomfort. However, due to the fast growing market of FF or DS and the accompanying strong advertising and marketing, also patients on medication may be stimulated to use FF or DS. This may have several consequences for the quality of drug treatment as stated by de Jong et al. with the example of the combined intake of plant sterols and/or stanols and statins (3) . Whereas they addressed the additive effect of plant sterols and/or stanols on reducing LDL-cholesterol values in patients on statin treatment, their main focus was the possible negative aspects of the combination, such as unfavourable effects on patient adherence with drug treatment and increasing the potential for food-drug interactions.In the present review we will focus on the possible beneficial effects that FF or DS may have on drug therapy. Because of the large number of subjects treated suboptimally with statins (hydroxymethylglutaryl Co...

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Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease Events

Rizos¹,

Ntzani²,

Bika³

et al. 2012

JAMA

879

545

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Context Considerable controversy exists regarding the association of omega-3 polyunsaturated fatty acids (PUFAs) and major cardiovascular end points.Objective To assess the role of omega-3 supplementation on major cardiovascular outcomes. Data Sources MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through August 2012.Study Selection Randomized clinical trials evaluating the effect of omega-3 on allcause mortality, cardiac death, sudden death, myocardial infarction, and stroke.Data Extraction Descriptive and quantitative information was extracted; absolute and relative risk (RR) estimates were synthesized under a random-effects model. Heterogeneity was assessed using the Q statistic and I 2 . Subgroup analyses were performed for the presence of blinding, the prevention settings, and patients with implantable cardioverter-defibrillators, and meta-regression analyses were performed for the omega-3 dose. A statistical significance threshold of .0063 was assumed after adjustment for multiple comparisons. Data SynthesisOf the 3635 citations retrieved, 20 studies of 68 680 patients were included, reporting 7044 deaths, 3993 cardiac deaths, 1150 sudden deaths, 1837 myocardial infarctions, and 1490 strokes. No statistically significant association was observed with all-cause mortality (

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Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis

Cited by 2,148 publications

References 40 publications

Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial

Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial

Support of drug therapy using functional foods and dietary supplements: focus on statin therapy

Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease Events

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