Research Highlights Benefits of Aspirin, Monoclonal Antibody Use in Patients With Diabetes, COVID-19

At the 5th annual Heart in Diabetes Conference hosted by The Metabolic Institute of America, investigators presented research on pharmacological interventions for individuals with diabetes who contract COVID-19 and use of monoclonal antibodies to prevent COVID-19 in patients with cardiovascular disease (CVD) and diabetes.

Aspirin Among Hospitalized Patients

In one abstract¹ presented at the conference, researchers from Saudi Arabia outlined the statistically significant effects of aspirin administration among hospitalized patients with COVID-19, diabetes, and obesity.

“It is estimated that people with cardiovascular risk factors are more prone for mortality and intubation [for COVID-19], especially obesity, and this is especially true in Saudi Arabia and the region of Hail, where morbid obesity (body mass index [BMI] >30 kg/m²) is at 33.6% of the population,” the authors wrote.

In an effort to establish an epidemiological link between aspirin use, diabetes, and intubation, the researchers measured mortality rates and readmissions over 30 days at a hospital in Saudi Arabia.

A total of 753 patients, the majority of whom were male (n = 545), were included in the retrospective cohort study, which analyzed data from April 1, 2020, to July 31, 2020. Most participants were between the ages of 42 and 61, and all were admitted with positive COVID-19 tests.

Of those included, approximately 40% had diabetes, with 18% of these patients needing intubation compared with just 7% of nondiabetic patients. The researchers found that, compared with those who took aspirin during their stay, those who did not receive aspirin had higher mortality and intubation rates, median intensive care unit (ICU) length of stay, and readmission rates.

In addition, “significant correlation was documented between BMI and days of ICU stay (P <.005),” the authors wrote, adding “in the global chronic disease syndrome with obesity and diabetes, the anti-aging gene may be repressed and the patients may be at risk for programmed cell death.”

Monoclonal Antibodies to Prevent COVID-19

Additional research² presented at the meeting found administration of Regeneron’s REGEN-COV monoclonal antibody combination (casirivimab and imdevimab) reduced the risk of developing COVID-19 in participants with CVD and/or diabetes regardless of serostatus, and was generally well tolerated.

“There is an unmet need for treatment options for individuals who are at an increased risk of moderate/severe COVID-19, including those with CVD and/or diabetes,” the authors wrote.

Previous studies have shown the monoclonal combination reduced COVID-19–related hospitalizations or death in symptomatic patients with COVID-19 and has prevented symptomatic infection in seronegative individuals compared with a placebo.

Investigators conducted a post hoc subgroup analysis of patients with CVD and/or diabetes, who were uninfected with COVID-19 at baseline but lived in the same house as an infected individual.

A total of 366 uninfected and seronegative participants were included in the study, which took place across centers in the United States, Romania, and Moldova. All participants had CVD and/or diabetes, a mean age of 55.5 years, and mean BMI of 31 kg/m².

To carry out the study, “uninfected (RT-qPCR-negative) individuals ≥12 years of age were randomized 1:1 to receive a single dose of REGEN-COV 1200 mg SC (600 mg casirivimab and 600 mg imdevimab) or placebo within 96 hours of the index case being diagnosed SARS-CoV-2 positive,” the authors explained.

Analyses revealed:

• In participants with CVD (n = 332) or diabetes (n = 103), the relative risk reduction (RRR) of developing symptomatic infection (ie, COVID-19; the primary end point) with REGEN-COV vs placebo was 54.9% and 69.0%, respectively
• Similar results were observed regardless of whether participants did or did not have CVD and/or diabetes
• Similar results were also observed when the analyses were performed regardless of baseline serology status: 59.6% and 76.3% RRRs for those with CVD and diabetes, respectively
• The proportion of participants in the REGEN-COV and placebo groups who experienced ≥1 treatment emergent adverse event (TEAE) was 22.4% vs 32.6% overall, and 17% vs 17.7% for non–COVID-19 TEAEs, respectively
• TEAEs occurring in more than 2% of REGEN-COV–treated participants with CVD included COVID-19, asymptomatic COVID-19, and injection-site reaction

The trial took place prior to the wide circulation of the delta COVID-19 variant. Although outside the study window, 3 participants died due to cardiac arrest, congestive heart failure, and sudden death.

Overall, results indicate “REGEN-COV represents an easy-to-administer option for the prevention of COVID-19 in high-risk persons, as a complement to vaccines,” the authors wrote. “Treatment with REGEN-COV reduced the risk of developing symptomatic disease, protecting vulnerable groups who have been in contact with an index case,” they concluded.

Five of the study authors are Regeneron employees.

References:

1. Vlachopoulou M, Hamissa EM, AbdAlgaffar SA, Chatzis G. COVID-19 and the systemic use of aspirin in diabetics during hospitalization: a retrospective study. Presented at: 5th Annual Heart in Diabetes; Sept 10-12, 2021. Virtual. Poster 0024.

2. O’Brien MP, Forleo-Neto E, Musser BJ, et al. COVID-19 prevention with subcutaneous administration of the monoclonal antibodies casirivimab and imdevimab: subgroup analysis in participants with cardiovascular disease and diabetes. Presented at: 5th Annual Heart in Diabetes; Sept 10-12, 2021. Virtual. Poster 0099.