Giving patients icosapent ethyl, or Vascepa, led to a 52% reduction of the total patient-reported symptom outcome prevalence score as compared with a 24% decline for outpatients who received usual care.
The first results from the CardioLink-9 Trial, a study of icosapent ethyl, icosapent ethyl, the purified fish oil derivative sold as Vascepa, in patients with coronavirus disease 2019 (COVID-19) indicated positive efficacy and safety results.
The results were presented virtually by Deepak L. Bhatt, MD, MPH, Brigham and Women’s Hospital at the National Lipid Association Scientific Sessions 2020, held earlier this month.
The study was funded by the maker of the icosapent ethyl, Amarin.
“In the current environment, most COVID-19 positive patients remain outside of the clinical setting, following the advice of their doctor to stay home and quarantine unless absolutely necessary to enter the hospital,” said Subodh Verma, MD, PhD, FRCSC, professor and cardiac surgeon at the University of Toronto and co-principal investigator of CardioLink-9, in a statement. “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. The reduction in markers of inflammation with icosapent ethyl is also important given what we know about the pathobiology of COVID-19.”
The CardioLink-9 Trial was a randomized, open-label study of that enrolled 100 outpatients positive for COVID-19 presenting with one of the following symptoms: fever, cough, sore throat, shortness of breath, or myalgia. The primary endpoint was biomarker changes in high-sensitivity C-reactive protein (hsCRP), as well as changes in the D-dimer. Patients randomized to the icosapent ethyl arm received a dose of 8 g/day for 3 days followed by 4 g/day for 11 days in additional to the standard of care. Patients in the control arm received only standard of care.
The authors found that patients who received icosapent ethyl resulted in a 25% reduction in hsCRP (P = 0.011) as well as a reduction in D-dimer (P = 0.048). Additionally, investigators assessed changes in COVID-19 symptoms from baseline to 14 days using the influenza patient-reported outcome (FLU-PRO) score. According to this measure, icosapent ethyl resulted in a significant 52% reduction of the total FLU-PRO prevalence score compared with a 24% reduction in the standard of care group (P = 0.003).
There were also declines across individual score domains, including a reduction in the icosapent ethyl arm compared with the standard of care arm in the body/systemic domain (54% vs. 26%, respectively; P = 0.003). Significant reductions in the FLU-PRO symptom score compared with standard of care were also seen in the total symptom score (P = 0.003), as well as in the body/systemic (P = 0.0007) and chest/respiratory (P = 0.01) areas.
These data were the latest in what has been a busy year for icosapent ethyl trials. In July, Bhatt presented data from the latest round of the REDUCE-IT study, which found that patients who took icosapent ethyl saw a 34% reduction in the first surgical procedure to restore blood flow to the heart, as well as a 36% overall drop in these procedures.
According to Amarin, the CardioLink-9 Trial is the first in a series of ongoing studies to determine the potential of icosapent ethyl therapy in patients with COVID-19.