Icosapent Ethyl

Table of Contents

1. What Icosapent Ethyl Is
2. How It Differs From Fish Oil and Other Prescription Omega-3s
3. The Two Uses on the US Label
4. Dosing as the Label Gives It
5. Severe Hypertriglyceridemia: The 12-Week Trials
6. REDUCE-IT: The Cardiovascular Outcomes Trial
7. JELIS: The Earlier Japanese Trial
8. STRENGTH and VITAL: Trials With Different Results
9. The Mineral-Oil Placebo Debate
10. Atrial Fibrillation and Bleeding
11. Other Safety Facts on the Label
12. What Is Not Known
13. Key Research Papers
14. Connections
15. Featured Videos

What Icosapent Ethyl Is

Eicosapentaenoic acid is one of the two long-chain omega-3 fats found in oily fish; the other is docosahexaenoic acid (DHA). In icosapent ethyl, eicosapentaenoic acid is joined to an ethyl group, which is what “ethyl ester” means. The US label describes it as “an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid,” with the chemical name ethyl all-cis-5,8,11,14,17-icosapentaenoate, the formula C₂₂H₃₄O₂ and a molecular weight of 330.51. The label gives 2012 as the year of first US approval.

The drug comes as amber, liquid-filled soft-gelatin capsules of 0.5 gram and 1 gram. Besides the active ingredient, the label lists tocopherol, gelatin, glycerin, maltitol, sorbitol and purified water. Many companies now sell generic versions under the generic name.

How the body handles it

According to the label, the ethyl ester is split off during digestion, and the freed eicosapentaenoic acid is absorbed in the small intestine and reaches the blood mainly through the lymph channel of the chest (the thoracic duct). Blood levels peak about 5 hours after a dose. The liver breaks eicosapentaenoic acid down mainly by beta-oxidation, the same route used for fats from food; the cytochrome P450 enzymes play only a minor part. The label gives an elimination half-life of about 89 hours and states that the drug is not excreted by the kidneys.

How it lowers triglycerides

The label states that studies suggest eicosapentaenoic acid reduces the liver's production or release of very-low-density lipoprotein triglycerides and speeds the clearing of triglycerides from those particles. The possible mechanisms it lists are more fat burning (beta-oxidation), blocking of the enzyme acyl-CoA:1,2-diacylglycerol acyltransferase, less fat-making in the liver, and more activity of lipoprotein lipase, the enzyme that clears triglycerides from the blood.

For the drop in heart events, the label is more cautious: the mechanisms “are not completely understood but are likely multi-factorial.” It notes that more eicosapentaenoic acid has been found in carotid artery plaque taken from treated patients, that the blood ratio of eicosapentaenoic acid to arachidonic acid rises, and that eicosapentaenoic acid inhibits platelet clumping under some laboratory conditions, adding that “the direct clinical meaning of individual findings is not clear.”

How It Differs From Fish Oil and Other Prescription Omega-3s

Three kinds of concentrated omega-3 product appear in the trials on this page, and they are not the same thing.

• Icosapent ethyl contains eicosapentaenoic acid only. The 12-week MARINE trial in severe hypertriglyceridemia described the drug as containing at least 96% eicosapentaenoic acid ethyl ester and no docosahexaenoic acid. It carries both a triglyceride use and a heart-risk use on its US label.
• Omega-3-acid ethyl esters are an older prescription drug that mixes both fats. Its US label states that each 1-gram capsule holds at least 900 mg of omega-3 ethyl esters, mainly about 465 mg of eicosapentaenoic acid and about 375 mg of docosahexaenoic acid. Its only labelled use is lowering severely high triglycerides (500 mg/dL or more), and its label states that its effect on cardiovascular death and illness “has not been determined.”
• Omega-3 carboxylic acids are a free-fatty-acid form of eicosapentaenoic acid plus docosahexaenoic acid. This was the product tested at 4 grams a day in the STRENGTH trial described below.

Fish-oil supplements bought without a prescription also contain a mixture of eicosapentaenoic acid and docosahexaenoic acid, in amounts that vary by product. The large supplement-style trial, VITAL, gave 1 gram a day of marine omega-3 fatty acids, while the prescription outcome trials gave 4 grams a day of a concentrated drug.

The cholesterol difference

One practical difference concerns low-density lipoprotein (LDL) cholesterol. The authors of the 12-week trial in severe hypertriglyceridemia wrote that triglyceride-lowering drugs such as fibrates, and fish oils containing both eicosapentaenoic acid and docosahexaenoic acid, can substantially raise low-density lipoprotein cholesterol in people whose triglycerides are 500 mg/dL or higher. The omega-3-acid ethyl esters label likewise states that in some patients the drug increases low-density lipoprotein cholesterol. In that trial, icosapent ethyl at 4 grams a day did not significantly change low-density lipoprotein cholesterol compared with placebo (a placebo-corrected change of −2.3%), and the icosapent ethyl label states that its triglyceride reduction was not associated with rises in low-density lipoprotein cholesterol compared with placebo.

The Two Uses on the US Label

The current US prescribing information (reference label on DailyMed, revised March 2026) lists two indications.

1. Heart-risk reduction. As an add-on to the highest statin dose a person tolerates, to reduce the risk of heart attack, stroke, coronary revascularization (stents or bypass surgery) and unstable angina requiring hospital care, in adults with triglycerides of 150 mg/dL or more who have either established cardiovascular disease, or diabetes plus 2 or more other risk factors for cardiovascular disease.
2. Severe hypertriglyceridemia. As an add-on to diet, to lower triglycerides in adults whose levels are 500 mg/dL or higher.

The label adds a limitation for the second use: the effect of the drug on the risk of pancreatitis in people with severe hypertriglyceridemia “has not been determined.” Background on the condition is on the Pancreatitis page.

The heart-risk wording follows the REDUCE-IT trial. That trial enrolled people with fasting triglycerides from 135 to 499 mg/dL; the label notes that 90% of those enrolled had triglycerides of 150 mg/dL or more and below 500 mg/dL, which is where the label's 150 mg/dL threshold sits.

Before treatment starts, the label describes checking blood fats and looking for other causes of high triglycerides, naming diabetes, an underactive thyroid and medicines as examples, along with diet and physical activity before and during treatment. Blood-fat testing itself is explained on the Lipid Panel page.

Dosing as the Label Gives It

The label gives one daily dose for both uses: 4 grams a day, taken either as four 0.5-gram capsules twice daily with food or as two 1-gram capsules twice daily with food. REDUCE-IT gave 2 grams twice daily, the same total of 4 grams. The label states that the capsules are swallowed whole and not broken open, crushed, dissolved or chewed.

In all the clinical studies the drug was taken with or after a meal, and the label states that no food-effect studies were performed. The patient leaflet states that if a full day is missed, the dose is not doubled the next day. Safety and effectiveness in children have not been established.

Severe Hypertriglyceridemia: The 12-Week Trials

The triglyceride use rests on short trials that measured blood fats, not heart attacks. In the MARINE trial, 229 people with fasting triglycerides between 500 and 2,000 mg/dL, with or without a statin, were randomly given 4 grams a day of the drug, 2 grams a day, or placebo for 12 weeks. Baseline triglycerides were 680, 657 and 703 mg/dL in the three groups.

• At 4 grams a day, triglycerides fell by 33.1% more than with placebo; at 2 grams a day, by 19.7%.
• In people starting above 750 mg/dL, the placebo-corrected falls were 45.4% at 4 grams and 32.9% at 2 grams.
• Low-density lipoprotein cholesterol did not change significantly (−2.3% at 4 grams, +5.2% at 2 grams).
• Non-high-density lipoprotein cholesterol, apolipoprotein B, lipoprotein-associated phospholipase A2, very-low-density lipoprotein cholesterol and total cholesterol all fell significantly.
• The authors reported a safety profile similar to placebo.

The label's own summary of this study (76 people on the drug, 75 on placebo) gives a median triglyceride change of −27% on the drug and +10% on placebo, a difference of −33%. In the two 12-week placebo-controlled trials pooled on the label, joint pain (arthralgia) and throat pain (oropharyngeal pain) were the side effects at least 1% more frequent than with placebo.

REDUCE-IT: The Cardiovascular Outcomes Trial

The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), published in 2019, is the trial behind the heart-risk indication. It was a multicenter, randomized, double-blind, placebo-controlled trial in people already taking a statin who had either established cardiovascular disease or diabetes with other risk factors, fasting triglycerides of 135 to 499 mg/dL and low-density lipoprotein cholesterol of 41 to 100 mg/dL. They received 2 grams of icosapent ethyl twice daily or a placebo.

A total of 8,179 people took part, 70.7% of them enrolled for secondary prevention (they already had cardiovascular disease), and they were followed for a median of 4.9 years. The label adds that the median age was 64 years, 29% were women, and the group was 90% White, 5% Asian and 2% Black. Median starting triglycerides were 216 mg/dL and median low-density lipoprotein cholesterol 75 mg/dL. The trial abstract states that it was funded by the drug's manufacturer.

What the trial found

A hazard ratio compares how often events happened in the two groups over time; a value below 1 means fewer events in the drug group.

• Main combined outcome (cardiovascular death, nonfatal heart attack, nonfatal stroke, coronary revascularization or unstable angina): 17.2% on the drug versus 22.0% on placebo, hazard ratio 0.75 (95% confidence interval 0.68 to 0.83). A later paper from the trial describes this as a 25% relative risk reduction.
• Key secondary outcome (cardiovascular death, nonfatal heart attack or nonfatal stroke): 11.2% versus 14.8%, hazard ratio 0.74.
• Cardiovascular death: 4.3% versus 5.2%, hazard ratio 0.80 (95% confidence interval 0.66 to 0.98; P=0.03).
• From the label's table: fatal or nonfatal heart attack 6.1% versus 8.7% (hazard ratio 0.69); emergency or urgent coronary revascularization 5.3% versus 7.8% (0.65); hospital care for unstable angina 2.6% versus 3.8% (0.68); fatal or nonfatal stroke 2.4% versus 3.3% (0.72).

A prespecified analysis that counted every event, not just each person's first, found 1,606 first and 1,303 later primary-outcome events. Total primary-outcome events ran at 61 versus 89 per 1,000 patient-years (rate ratio 0.70, 95% confidence interval 0.62 to 0.78).

What happened to blood fats

The label reports that at one year, median triglycerides changed by −18% on the drug and +2% on placebo, and median low-density lipoprotein cholesterol by +3% on the drug and +10% on placebo. That rise in the placebo group is part of the debate described further down. The Omega-3 Fatty Acids for Cardiovascular Health article places REDUCE-IT among the other omega-3 trials.

JELIS: The Earlier Japanese Trial

Before REDUCE-IT, the Japan EPA Lipid Intervention Study (JELIS), published in 2007, tested eicosapentaenoic acid alone in a population that eats a large amount of fish. It recruited 18,645 people with total cholesterol of 6.5 mmol/L or more and randomly assigned them to 1,800 mg of eicosapentaenoic acid a day with a statin (9,326 people) or a statin alone (9,319 people). There was no placebo: patients knew which group they were in, though the outcomes were judged by reviewers who did not know (an “open-label, blinded endpoint” design).

• At a mean of 4.6 years, major coronary events occurred in 262 people (2.8%) on eicosapentaenoic acid and 324 (3.5%) on statin alone, a 19% relative reduction (p=0.011).
• Unstable angina and nonfatal coronary events were significantly reduced; sudden cardiac death and coronary death did not differ between the groups.
• Low-density lipoprotein cholesterol fell 25% in both groups, and the authors found it was not a significant factor in the drop in coronary events.
• In people who already had coronary artery disease, events fell from 10.7% to 8.7% (p=0.048). In people without it, the 18% reduction (1.7% to 1.4%) was not statistically significant (p=0.132).

JELIS gave 1,800 mg a day, while REDUCE-IT gave 4 grams a day, and JELIS compared the drug with no added treatment rather than with an oil placebo, which is why it is often brought into the placebo debate below.

STRENGTH and VITAL: Trials With Different Results

STRENGTH (2020)

STRENGTH asked a similar question with a different product. It randomized 13,078 statin-treated people at high cardiovascular risk, with high triglycerides and low high-density lipoprotein cholesterol, at 675 hospitals in 22 countries, to 4 grams a day of omega-3 carboxylic acids (eicosapentaenoic acid plus docosahexaenoic acid) or to corn oil, “intended to serve as an inert comparator.” Seventy percent had diabetes and median triglycerides were 240 mg/dL.

• The trial was stopped early, after 1,384 of a planned 1,600 primary events, because an interim analysis showed a low probability of benefit.
• The main combined outcome (the same five components as REDUCE-IT) occurred in 12.0% on omega-3 versus 12.2% on corn oil, hazard ratio 0.99 (95% confidence interval 0.90 to 1.09; P=.84).
• Gastrointestinal side effects were more common on omega-3 (24.7% versus 14.7%).

The authors wrote that the findings do not support this omega-3 formulation for reducing major cardiovascular events in high-risk patients.

VITAL (2019)

VITAL tested a lower dose in a different population: 25,871 US men aged 50 or older and women aged 55 or older, not selected for heart disease, took 1 gram a day of marine omega-3 fatty acids or placebo, in a design that also tested vitamin D. Over a median of 5.3 years, major cardiovascular events occurred in 386 people on omega-3 and 419 on placebo (hazard ratio 0.92, 95% confidence interval 0.80 to 1.06; P=0.24), a result that was not statistically significant. Among the secondary outcomes, total heart attacks had a hazard ratio of 0.72 (0.59 to 0.90), stroke 1.04 and cardiovascular death 0.96. No excess bleeding or other serious adverse events were seen.

Putting the trials side by side

The contrast has been read in more than one way. One reading is that eicosapentaenoic acid alone acts differently from a mixture with docosahexaenoic acid. A 2021 meta-analysis of 38 randomized trials (149,051 participants) reported larger relative reductions with eicosapentaenoic acid alone than with the combination: for cardiovascular death, a rate ratio of 0.82 with eicosapentaenoic acid alone versus 0.94 with the combination, and for nonfatal heart attack 0.72 versus 0.92. Another reading points to the placebos: corn oil in STRENGTH and mineral oil in REDUCE-IT. The dose and the people studied also differed: VITAL gave 1 gram a day to people at usual risk, while REDUCE-IT and STRENGTH gave 4 grams a day to people at high risk.

The Mineral-Oil Placebo Debate

REDUCE-IT's placebo capsules contained pharmaceutical-grade mineral oil. Researchers have since argued in print over whether part of the trial's result came from harmful effects of the mineral oil in the placebo group, which would widen the gap between the groups, or whether the mineral oil was a neutral comparison. This page reports the published positions; it does not settle the question.

The biomarker substudy (2022)

Researchers including REDUCE-IT investigators measured seven blood markers linked to artery disease in REDUCE-IT participants. In the mineral-oil group, levels rose over time; at 12 months the median increases from baseline were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density lipoprotein cholesterol, 16.2% for interleukin-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein and 28.9% for interleukin-1β (all P<0.001). In the icosapent ethyl group these markers changed very little. By the end of the study the between-group differences were 48.7% for interleukin-1β and 38.5% for high-sensitivity C-reactive protein, “largely” reflecting increases in the mineral-oil group. The paper recalls that at 12 months low-density lipoprotein cholesterol had changed by −1.2% on icosapent ethyl and by 10.9% on mineral oil. The authors concluded that the effect of these findings on the interpretation of the trial's overall risk reduction “is uncertain.”

The Copenhagen modelling study (2021)

Danish researchers used the Copenhagen General Population Study, with 106,088 people, to pick out those who would have qualified for REDUCE-IT (5,684 people) and for STRENGTH (6,862 people). They then estimated how the changes in triglycerides, low-density lipoprotein cholesterol and C-reactive protein seen in each trial arm would translate into risk. For the comparator oils, the estimated hazard ratios were 1.07 (95% confidence interval 1.04 to 1.10) mimicking the mineral oil of REDUCE-IT and 0.99 mimicking the corn oil of STRENGTH. Combining both arms, the estimated active-versus-comparator hazard ratio was 0.88 in the population mimicking REDUCE-IT, against 0.75 actually observed in the trial. The authors concluded that the contrasting results “can partly be explained” by the different comparator oils but not by the different active oils, and that the unexplained additional 13% risk reduction in REDUCE-IT likely came through other effects of eicosapentaenoic acid or of mineral oil.

The mineral-oil safety review (2020)

A review whose authors include REDUCE-IT investigators searched the literature and found 80 studies that used mineral-oil placebos. It reported that side effects of mineral oil were generally gastrointestinal, consistent with its use as a lubricant laxative; that changes in triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, high-sensitivity C-reactive protein and other markers were inconsistent and generally not statistically significant; and that there was no consistent evidence that mineral oil in the amounts used affects the absorption of nutrients or drugs, including statins. Its authors concluded that mineral oil “does not meaningfully affect study conclusions” at the quantities used in clinical trials.

These three papers reach different readings of the same trial. The open-label JELIS trial, which had no oil placebo, also found fewer coronary events with eicosapentaenoic acid, though with a lower dose, a different population and a design in which patients knew their treatment.

Atrial Fibrillation and Bleeding

The label lists two important hazards under Warnings and Precautions, both seen in the outcomes trial: irregular heart rhythm and bleeding. Background on the rhythm problem is on the Atrial Fibrillation page.

Atrial fibrillation and flutter

• Label: in the 8,179-person outcomes trial, adjudicated atrial fibrillation or atrial flutter needing a hospital stay of 24 hours or more occurred in 127 people (3%) on the drug and 84 (2%) on placebo, hazard ratio 1.5 (95% confidence interval 1.14 to 1.98). The label states that atrial fibrillation was more common in people with a past history of atrial fibrillation or flutter.
• Trial paper: hospitalization for atrial fibrillation or flutter occurred in 3.1% on the drug and 2.1% on placebo (P=0.004).
• 2021 meta-analysis: pooling 7 cardiovascular outcome trials of marine omega-3 fatty acids with 81,210 patients (mean age 65, weighted average follow-up 4.9 years), supplementation was associated with a higher risk of atrial fibrillation, hazard ratio 1.25 (95% confidence interval 1.07 to 1.46). The hazard ratio was 1.49 in trials giving more than 1 gram a day and 1.12 in trials giving 1 gram a day or less, and it rose by a hazard ratio of 1.11 for each additional gram a day.
• The 38-trial meta-analysis: eicosapentaenoic acid alone, compared with control, was associated with more atrial fibrillation (rate ratio 1.35).

The patient leaflet lists the symptoms of heart rhythm problems as a fast and irregular heartbeat, lightheadedness, dizziness, shortness of breath, chest discomfort or fainting, and notes that such problems can be serious and lead to hospital care.

Bleeding

• Label: in the outcomes trial, 482 people (12%) on the drug had a bleeding event compared with 404 (10%) on placebo; serious bleeding occurred in 111 (3%) versus 85 (2%). Bleeding was more common in people also taking antithrombotic medicines such as aspirin, clopidogrel or warfarin.
• Trial paper: serious bleeding events occurred in 2.7% versus 2.1% (P=0.06).
• The 38-trial meta-analysis: eicosapentaenoic acid alone was associated with more total bleeding than control (rate ratio 1.49).
• The label notes that some published studies of omega-3 fatty acids showed a longer bleeding time, which did not exceed normal limits and did not produce clinically significant bleeding. In a study of 25 healthy adults, 4 grams a day did not significantly change warfarin blood levels or warfarin's effect on clotting. The label calls for monitoring for bleeding in people also taking anticoagulant or antiplatelet medicines (see the Aspirin page for that drug's own bleeding findings).

Other Safety Facts on the Label

• Common side effects. In the outcomes trial, the side effects seen in at least 3% of people on the drug and at least 1% more often than on placebo were musculoskeletal pain, swelling of the hands, legs or feet (peripheral edema), constipation, gout and atrial fibrillation.
• Reports since approval. Diarrhea, raised blood triglycerides, abdominal discomfort and pain in the arms or legs have been reported voluntarily after approval; the label notes that frequency and cause cannot be reliably established from such reports.
• Fish and shellfish allergy. The drug is made from fish oil. The label states that it is not known whether people allergic to fish or shellfish face a higher risk of an allergic reaction to it. The only contraindication is a known allergy, such as anaphylaxis, to the drug or any of its ingredients.
• Liver. In people with liver impairment, the label calls for periodic checks of the liver enzymes alanine aminotransferase and aspartate aminotransferase. The drug has not been studied in people with kidney or liver impairment.
• Other medicines. In studies of healthy adults, 4 grams a day did not significantly change blood levels of omeprazole, rosiglitazone or atorvastatin.
• Pregnancy and breastfeeding. The label states that the human data are insufficient to identify a drug-related risk of birth defects, miscarriage or other harm. In pregnant rats, some minor developmental findings that were not related to dose were seen at exposures similar to the human dose. Omega-3 fatty acids, including eicosapentaenoic acid, have been detected in human milk, and there are no data on effects in the breastfed infant.
• Older adults. Of the people in well-controlled studies, 45% were 65 or older, and no overall differences in safety or effectiveness were seen.

What Is Not Known

• Why the heart events fell. The label calls the mechanisms not completely understood; it lists more eicosapentaenoic acid in artery plaque, a higher blood ratio of eicosapentaenoic acid to arachidonic acid and effects on platelets as findings whose direct clinical meaning is not clear.
• How much of the REDUCE-IT result reflects the drug and how much the mineral-oil placebo. The trial's own biomarker paper calls this uncertain, and the published analyses above disagree.
• Whether eicosapentaenoic acid alone truly differs from a mixture with docosahexaenoic acid. The evidence comes from comparing different trials with different products, placebos, doses and populations, not from a trial testing the two side by side.
• Whether the drug lowers the risk of pancreatitis in severe hypertriglyceridemia; the label states this has not been determined.
• How the results apply to groups who were few in the trial. In REDUCE-IT, 29% were women and 2% were Black, and in JELIS the benefit in people without known coronary disease was not statistically significant.
• Safety and effectiveness in children, which have not been established, and safety in pregnancy, for which human data are insufficient.
• The trials on this page did not compare the prescription drug directly with over-the-counter fish oil or with eating oily fish.

Decisions about prescription medicines belong with a clinician who knows the person's history, including any heart-rhythm problems and blood-thinning medicines.

Key Research Papers

1. Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22. PubMed PMID: 30415628
2. Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73(22):2791-2802. PubMed PMID: 30898607
3. Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial). Am J Cardiol. 2011;108(5):682-90. PubMed PMID: 21683321
4. Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet. 2007;369(9567):1090-8. PubMed PMID: 17398308
5. Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, et al. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA. 2020;324(22):2268-2280. PubMed PMID: 33190147
6. Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, et al. Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer. N Engl J Med. 2019;380(1):23-32. PubMed PMID: 30415637
7. Khan SU, Lone AN, Khan MS, Virani SS, Blumenthal RS, Nasir K, et al. Effect of omega-3 fatty acids on cardiovascular outcomes: A systematic review and meta-analysis. EClinicalMedicine. 2021;38:100997. PubMed PMID: 34505026
8. Ridker PM, Rifai N, MacFadyen J, Glynn RJ, Jiao L, Steg PG, et al. Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1β, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy. Circulation. 2022;146(5):372-379. PubMed PMID: 35762321
9. Doi T, Langsted A, Nordestgaard BG. A possible explanation for the contrasting results of REDUCE-IT vs. STRENGTH: cohort study mimicking trial designs. Eur Heart J. 2021;42(47):4807-4817. PubMed PMID: 34455435
10. Olshansky B, Chung MK, Budoff MJ, Philip S, Jiao L, Doyle RT, et al. Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies. Eur Heart J Suppl. 2020;22(Suppl J):J34-J48. PubMed PMID: 33061866
11. Gencer B, Djousse L, Al-Ramady OT, Cook NR, Manson JE, Albert CM. Effect of Long-Term Marine ɷ-3 Fatty Acids Supplementation on the Risk of Atrial Fibrillation in Randomized Controlled Trials of Cardiovascular Outcomes: A Systematic Review and Meta-Analysis. Circulation. 2021;144(25):1981-1990. PubMed PMID: 34612056

PubMed Topic Searches

1. PubMed: icosapent ethyl and cardiovascular outcomes
2. PubMed: REDUCE-IT and the mineral-oil placebo
3. PubMed: eicosapentaenoic acid ethyl ester and hypertriglyceridemia
4. PubMed: omega-3 fatty acids and atrial fibrillation

Connections

• Drugs — every drug page on the site
• Omega-3 Fatty Acids — the three omega-3 fats, food sources and supplements
• Omega-3 Fatty Acids for Cardiovascular Health — the full run of omega-3 heart trials
• Salmon Omega-3: Eicosapentaenoic Acid and Docosahexaenoic Acid — the whole-food source
• Fenofibrate — another triglyceride-lowering drug
• Lipid Panel — how triglycerides and cholesterol are measured
• Atrial Fibrillation — the rhythm problem on the label's warnings
• Cholesterol Management — statins and other lipid treatments

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