National Lipid Association

National Lipid Association

Source:

Kosmopoulos A, et al. Late-breaker presentations. Presented at: National Lipid Association Scientific Sessions; Dec. 10-12, 2020 (virtual meeting).

Disclosures: The study was sponsored by Amarin and HLS Therapeutics. Bhatt reports he has financial ties with numerous pharmaceutical and device companies, including receiving research funding from Amarin.
December 16, 2020
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Icosapent ethyl appears to reduce inflammation, improve symptoms in COVID-19

Source:

Kosmopoulos A, et al. Late-breaker presentations. Presented at: National Lipid Association Scientific Sessions; Dec. 10-12, 2020 (virtual meeting).

Disclosures: The study was sponsored by Amarin and HLS Therapeutics. Bhatt reports he has financial ties with numerous pharmaceutical and device companies, including receiving research funding from Amarin.
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In a first-in-human study, icosapent ethyl reduced levels of inflammatory biomarkers and improved symptoms in patients with COVID-19, researchers reported at the virtual National Lipid Association Scientific Sessions.

Deepak L. Bhatt

“This study provides the first evidence of an early anti-inflammatory effect of icosapent ethyl in symptomatic COVID-19-positive outpatients,” Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said during a presentation.

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For the open-label COVID-19 Cardiolink-9 study, the researchers randomly assigned 100 symptomatic patients with COVID-19 (mean age, 43 years; 55% women) to icosapent ethyl (Vascepa, Amarin) plus usual care or usual care alone. Those assigned icosapent ethyl received a dose of 4 g twice daily for 3 days, then a dose of 2 g twice daily for 11 days. The inflammation outcome was change in high-sensitivity C-reactive protein level at 14 days. The clinical outcome was change in influenza patient-reported outcome (FLU-PRO) score, a 32-item score across six domains, at 14 days.

The most common symptom in the cohort was myalgia, followed by cough, loss of taste, loss of smell, fever, sore throat and shortness of breath, Bhatt said during the presentation.

The level of hsCRP declined 25% in the icosapent ethyl group (P = .011) compared with 5.6% in the control group (P = .51; between-group P = .082), Bhatt said.

After adjustment for age, sex and baseline CV risk, the difference between the groups in hsCRP decline was significant (between-group P = .043), he said.

The icosapent ethyl group also had a decline in D-dimer levels (P = .048), he said.

“The 25% reduction in hsCRP levels is consistent with anti-inflammatory effects of icosapent ethyl demonstrated in hypertriglyceridemic patients,” Bhatt said.

The prevalence of FLU-PRO symptoms dropped from 100% at baseline to 48% at 14 days in the icosapent ethyl group compared with a drop from 100% to 76% at 14 days in the control group (P = .003), driven by improvement in body/systemic symptoms (P = .003), according to the researchers.

For change in FLU-PRO total and domain scores at 14 days, there was more improvement in the icosapent ethyl group compared with the control group in total score (P = .003), body/systemic domain score (P = .0007) and chest/respiratory domain score (P = .01), Bhatt said.

He said the drug was safe and well tolerated, but was associated with more gastrointestinal adverse events (8% vs. 0%).

“The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated and relatively inexpensive option to impact upon COVID-19-related morbidity, although this finding should be confirmed in a double-blind, placebo-controlled trial,” Bhatt said.

There was a correlation between improvement in hsCRP with improvement in FLU-PRO score in the icosapent ethyl group but not in the control group, he said.

The study “has demonstrated the safety and tolerability of this loading dose in a modest sample size, which is being confirmed in PREPARE-IT 1 and PREPARE-IT 2,” Bhatt said during the presentation. “The safety experience opens the door on future studies using a loading dose in other conditions, including at the time of acute coronary syndromes, stroke, PCI and CABG.”