A new meta-analysis of 7 randomized controlled trials found no statistically significant increase in cardiac adverse events among COVID-19 patients who were treated with remdesivir compared with those who received standard care or placebo.
The analysis included data from 4566 adult patients who were enrolled in trials conducted before April 2021. Of these, 306 patients (6.6%) experienced cardiac adverse events (CAEs): 149 in the remdesivir group and 157 in the control group. The pooled risk ratio was 0.84 (95% confidence interval [CI] = 0.68–1.04, P = .118), which indicated no significant difference between treatment groups.
Led by Chengliang Yang of the University of British Columbia, the investigators assessed specific cardiac events such as arrhythmias, heart failure, and myocardial disorders. Cardiac arrhythmias were the most frequent; they occurred in 5% of patients who received remdesivir and 5.6% of those in control groups. No individual cardiac event type showed a statistically significant difference.
Subgroup analyses examined whether patients with comorbidities faced increased risk. Among patients with diabetes, the risk ratio for CAEs was 0.65 (95% CI = 0.40–1.06, P = .081). For those with cardiovascular disease, the risk ratio was 0.73 (95% CI = 0.38–1.41, P =.351). Neither group showed a significant increase in heart-related complications with remdesivir.
The pooled patient population was a median age of 58.9 years (interquartile range [IQR] = 57.95–64.25), and 62.1% were male. Among patients who experienced CAEs, the median age was 69 years (IQR = 66–70), and 78.1% were male. Among these patients, 33.3% had cardiovascular disease, 35.9% had diabetes, 13.9% had chronic lung disease, 2.2% had chronic liver disease, and 42.6% had obesity.
Sex-based subgroup analyses yielded similar risk estimates. The risk ratio was 0.81 (95% CI = 0.57–1.13) in male patients, and 0.78 (95% CI = 0.47–1.28) in female patients . These confidence intervals included both possible harm and benefit, which indicated imprecision and no conclusive sex-specific effect.
All included studies were conducted in unvaccinated populations prior to the emergence of Omicron and other SARS-CoV-2 variants. Review during this timeframe allowed researchers to assess the cardiac safety of remdesivir without confounding factors from vaccination-related myocarditis or variant-specific disease profiles.
The certainty of evidence, which was assessed using the GRADE framework, was rated moderate for overall CAEs, low for arrhythmias and heart failure, and very low for myocardial disorders. These ratings reflected imprecision, small sample sizes, and study-level limitations.
The researchers concluded that remdesivir was not associated with an increased risk of cardiac complications in COVID-19 patients. While the point estimate suggested a possible reduction in risk, the results were not statistically significant.
"Further research is warranted to assess long-term cardiac outcomes, evaluate safety in vaccinated populations and understand remdesivir’s role across different SARS-CoV-2 variants," they wrote.
Full disclosures can be found in the published study.
Source: BMJ Open