A randomized trial of icosapent ethyl in ambulatory patients with COVID-19

Kosmopoulos, Andrew; Bhatt, Deepak L.; Meglis, Gus; Verma, Raj; Pan, Yixin; Quan, Adrian; Teoh, Hwee; Verma, Maya; Jiao, Lixia; Wang, Robert; Juliano, Rebecca A.; Kajil, Mahesh; Kosiborod, Mikhail; Bari, Basel; Berih, Abdullahi A.; Aguilar, Mallory; Escano, Antonnette; Leung, A. F.; Coelho, Idelta; Hibino, Makoto; Díaz, Rafael Tejeda; Mason, R. Preston; Steg, Ph. Gabriel; Simon, Tabassome; Go, Alan S.; Ambrosy, Andrew P.; Choi, Richard; Kushner, Arthur M.; Leiter, Lawrence A.; Al‐Omran, Mohammed; Verma, Subodh; Mazer, C. David

doi:10.1016/j.isci.2021.103040

Cited by 22 publications

(25 citation statements)

References 23 publications

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“… 11 , 42 In each of these trials, and even recently among patients with COVID‐19, high‐dose EPA in the form of icosapent ethyl has been well tolerated. 43 , 44 …”

Section: Discussionmentioning

confidence: 99%

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Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Peterson

Bhatt

Steg

et al. 2022

JAHA

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Background Patients who undergo percutaneous coronary intervention (PCI) are at increased risk for recurrent cardiovascular events despite aggressive medical therapy. Methods and Results This post hoc analysis focused on the subset of patients with prior PCI enrolled in REDUCE‐IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, randomized, double‐blind, placebo‐controlled trial of icosapent ethyl versus placebo. Icosapent ethyl was added to statins in patients with low‐density lipoprotein cholesterol <100 mg/dL and fasting triglycerides 135–499 mg/dL. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. There were 8179 patients randomized in REDUCE‐IT followed for a median of 4.9 years, and 3408 (41.7%) of them had a prior PCI with a median follow‐up of 4.8 years. These patients were randomized a median of 2.9 years (11 days to 30.7 years) after PCI. Among patients treated with icosapent ethyl versus placebo, there was a 34% reduction in the primary composite end point (hazard ratio [HR], 0.66; 95% CI, 0.58–0.76; P <0.001; number needed to treat 4.8 years =12) and a 34% reduction in the key secondary composite end point of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (HR, 0.66; 95% CI, 0.56–0.79; P <0.001; NNT 4.8 years =19) versus placebo. Similarly, large reductions occurred in total coronary revascularizations and revascularization subtypes. There was also a 39% reduction in total events (rate ratio, 0.61; 95% CI, 0.52–0.72; P <0.001). Conclusions Among patients treated with statins with elevated triglycerides and a history of prior PCI, icosapent ethyl substantially reduced the risk of recurrent events during an average of ~5 years of follow‐up with a number needed to treat of only 12. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

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“… 11 , 42 In each of these trials, and even recently among patients with COVID‐19, high‐dose EPA in the form of icosapent ethyl has been well tolerated. 43 , 44 …”

Section: Discussionmentioning

confidence: 99%

“…Also, had patients been enrolled soon after PCI when risk is highest, the degree of benefit seen here may have been even greater, especially if future studies validate the use of a loading dose. 43 …”

Section: Discussionmentioning

confidence: 99%

Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Peterson

Bhatt

Steg

et al. 2022

JAHA

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“…However, the results of recent randomized controlled trials (RCTs) of omega-3 fatty acids in COVID-19 are controversial. None of the RCTs that investigated the effects of omega-3 fatty acid supplementation measured the Omega-3 Index, and only one of these RCTs included DHA as an integral part of the intervention [ 19 , 20 , 21 ]. The internal validity of these RCTs is questionable because the failure to include the O3I as a reliable biomarker of the omega-3 status of patients does not enable valid comparisons to be made between the RCT arms; clinical events correlate more significantly with blood levels of EPA and DHA than with the supplemented amounts of these fatty acids.…”

Section: Discussionmentioning

confidence: 99%

Inverse Association between Omega-3 Index and Severity of COVID-19: A Case–Control Study

Ramírez-Santana

Barra

González

et al. 2022

IJERPH

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Background: Omega-3 fatty acids enhance immune response and modulate inflammation. This study aimed to determine the relationship between omega-3 fatty acid status and the severity of SARS-CoV-2 infection. Methods: Using a case–control design, we compared hospitalized patients with severe SARS-CoV-2 infection (cases, n = 73) with a group of ambulatory patients with mild SARS-CoV-2 infection (controls, n = 71). No patients were vaccinated against SARS-CoV-2. Results: The cases were older (p = 0.003), less educated (p = 0.001), had larger neck and smaller waist circumferences (p = 0.035 and p = 0.003, respectively), more frequently had diabetes (p < 0.001), consumed less fish (p < 0.001), consumed higher proportions of fried fish (p = 0.001), and had lower Omega-3 Index (O3I) values (p = 0.001) than controls. Cases had significantly lower rates of upper airway symptoms than controls. Lower O3I was associated with an increased likelihood of developing severe COVID-19 after adjusting for potential confounders (OR: 0.52; CI 0.32–0.86). Diabetes (OR: 4.41; CI 1.60–12.12), neck circumference (OR: 1.12; CI 1.03–1.21), and older age (OR: 1.03; CI 1.002–1.062) were also linked to COVID-19 severity. Fried fish consumption and low educational level were independent risk factors for severe COVID-19. Conclusions: This study suggests incorporating nutritional interventions to improve omega-3 status within nonpharmacological measures may help to reduce the severity of COVID-19.

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“…Therefore, the timing of management by n-3 PUFAs with regard to the actual clinical status of the given individual could also be of importance. However, recently available data did not show the protective effects of icosapent ethyl in COVID-19 [54][55][56].…”

Section: The Effect Of N-3 Pufas On Inflammatory and Prothrombogenic ...mentioning

confidence: 99%

Omega-3 Polyunsaturated Fatty Acids—Vascular and Cardiac Effects on the Cellular and Molecular Level (Narrative Review)

Drenjančević-Perić

Piťha

2022

IJMS

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In the prevention and treatment of cardiovascular disease, in addition to the already proven effective treatment of dyslipidemia, hypertension and diabetes mellitus, omega-3 polyunsaturated fatty acids (n-3 PUFAs) are considered as substances with additive effects on cardiovascular health. N-3 PUFAs combine their indirect effects on metabolic, inflammatory and thrombogenic parameters with direct effects on the cellular level. Eicosapentaenoic acid (EPA) seems to be more efficient than docosahexaenoic acid (DHA) in the favorable mitigation of atherothrombosis due to its specific molecular properties. The inferred mechanism is a more favorable effect on the cell membrane. In addition, the anti-fibrotic effects of n-3 PUFA were described, with potential impacts on heart failure with a preserved ejection fraction. Furthermore, n-3 PUFA can modify ion channels, with a favorable impact on arrhythmias. However, despite recent evidence in the prevention of cardiovascular disease by a relatively high dose of icosapent ethyl (EPA derivative), there is still a paucity of data describing the exact mechanisms of n-3 PUFAs, including the role of their particular metabolites. The purpose of this review is to discuss the effects of n-3 PUFAs at several levels of the cardiovascular system, including controversies.

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A randomized trial of icosapent ethyl in ambulatory patients with COVID-19

Cited by 22 publications

References 23 publications

Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Inverse Association between Omega-3 Index and Severity of COVID-19: A Case–Control Study

Omega-3 Polyunsaturated Fatty Acids—Vascular and Cardiac Effects on the Cellular and Molecular Level (Narrative Review)

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