Infectious Disease

Icosapent Ethyl seems to cut back irritation and enhance signs of COVID-19

December 16, 2020

2 min read

Source / information

Source:

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

Disclosure:
The study was sponsored by Amarin and HLS Therapeutics. Bhatt reports that he has financial relationships with numerous pharmaceutical and device companies, including research funding from Amarin.

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

In a first-in-human study, icosapent Ethyl reduced inflammatory biomarker levels and improved symptoms in patients with COVID-19, researchers reported at the National Lipid Association’s virtual science sessions.

Deepak L. Bhatt

“This study provides the first evidence of early anti-inflammatory effects of icosapent Ethyl in symptomatic COVID-19 positive outpatients,” said the editor of Cardiology Today Intervention Deepak L. Bhatt, MD, MPH, Executive Director for Interventional Cardiology Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School said during a presentation.

Source: Adobe Stock

For the open-label COVID-19 Cardiolink-9 study, 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 result of inflammation was a change in the highly sensitive C-reactive protein level after 14 days. The clinical outcome was a change in the Influenza Patient Reported Outcome (FLU-PRO) score, a 32-point score over six domains after 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 decreased in the icosapent ethyl group by 25% (P = 0.011) compared to 5.6% in the control group (P = 0.51; between groups, P = 0.082), said Bhatt.

After adjusting for age, gender, and baseline CV risk, the intergroup difference in hsCRP decline was significant (intergroup P = 0.043), he said.

The icosapent ethyl group also had a decrease in D-dimer levels (P = 0.048), he said.

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

The prevalence of FLU-PRO symptoms decreased from 100% at baseline to 48% after 14 days in the ikosapent ethyl group, compared with a decrease from 100% to 76% after 14 days in the control group (P = 0.003), driven by Improvement in physical / systemic symptoms (P = 0.003), the researchers said.

For the change in the FLU-PRO total and domain scores after 14 days, there was a greater improvement in the icosapent ethyl group compared to the control group with regard to the overall evaluation (P = 0.003), the body / system domain evaluation (P = 0 , 0007) and chest / respiratory domain score (P = 0.01), said Bhatt.

He said the drug was safe and well tolerated, but associated with more gastrointestinal side effects (8% versus 0%).

“The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive way to influence COVID-19-related morbidity, although this finding should be confirmed in a double-blind, placebo-controlled study. Said Bhatt.

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

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

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

National Lipid Association

National Lipid Association

Related Articles