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Cardiovascular Safety of COVID-19 Treatments: A Disproportionality Analysis of Adverse Event Reports from the WHO
Hoi K Cheng1, Angel Lai1, Maxwell Kwok2,3
1Division of Cardiology, Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong (CUHK), Hong Kong SAR, China.
Insights
Certain COVID-19 treatments, like remdesivir and baricitinib, may increase cardiovascular risks. Other antivirals showed reduced risks, highlighting the need for ongoing safety monitoring of these critical therapies.
Area of Science:
- Pharmacology
- Cardiovascular Medicine
- Infectious Diseases
Background:
- The high mortality of Coronavirus Disease 2019 (COVID-19) necessitates safe and effective treatments.
- Approved COVID-19 therapies include antivirals (e.g., remdesivir, molnupiravir, nirmatrelvir/ritonavir) and immunomodulators (e.g., baricitinib, tocilizumab).
- Initial clinical trials may not fully reveal serious cardiovascular adverse events (CVAEs).
Purpose of the Study:
- To retrospectively analyze cardiovascular adverse events (CVAEs) associated with WHO-recommended COVID-19 therapies.
- To assess the comparative cardiovascular safety profiles of different COVID-19 treatments.
- To identify potential safety differences among immunomodulators for severe COVID-19.
Main Methods:
- Retrospective analysis of CVAEs using the WHO VigiBase database (March 2020 - July 2023).
- Inclusion of five WHO-recommended COVID-19 therapies.
- Calculation of adjusted reporting odds ratios (aROR) with 95% confidence intervals (CI) to evaluate CVAE risks.
Main Results:
- Remdesivir was linked to increased CVAE odds, notably bradycardia (aROR 2.4).
- Nirmatrelvir/ritonavir and molnupiravir were associated with reduced CVAE odds.
- Baricitinib showed increased CVAE risk (aROR 2.31), particularly deep vein thrombosis (aROR 45.34).
- CVAEs were more frequent during the Omicron variant period.
Conclusions:
- Pharmacovigilance is crucial for monitoring COVID-19 therapies.
- Significant differences in cardiovascular safety exist among COVID-19 immunomodulators.
- Further clinical trials comparing tocilizumab and baricitinib are needed for severe COVID-19 patients.
- Study findings can inform future antiviral repurposing and pandemic preparedness.
Introduction:
The high mortality of Coronavirus Disease 2019 (COVID-19) highlights the need for safe and effective antiviral treatment. Small molecular antivirals (remdesivir, molnupiravir, nirmatrelvir/ritonavir) and immunomodulators (baricitinib, tocilizumab) have been developed or repurposed to suppress viral replication and ameliorate cytokine storms, respectively. Despite U.S. Food and Drug Administration (FDA) approval, serious cardiovascular adverse events (CVAEs) may not be apparent in initial trials.
Methods:
A retrospective analysis of CVAEs linked to five World Health Organization (WHO) recommended COVID-19 therapies was conducted using the WHO VigiBase database from March 2020 to July 2023. Adjusted reporting odds ratios (aROR) with 95% confidence intervals (CI) were calculated to assess CVAE risks.
Results:
A total of 276,631 AEs were reported to be associated with COVID-19, of which 13,091 were classified as cardiovascular events. Remdesivir was associated with significantly increased odds of CVAEs, particularly bradycardia (aROR 2.4, 95% CI 2.28-2.52). In contrast, nirmatrelvir/ritonavir and molnupiravir showed reduced CVAEs odds. Among immunomodulators, baricitinib was associated with increased CVAEs risk (aROR 2.31, 95% CI 2.07-2.59), with deep vein thrombosis being the most prominent (aROR 45.34, 95% CI 34.89-58.9), accounting for 38.8% of reported study cases in the database. Also, CVAEs odds were higher during the Omicron period compared to pre-Omicron period.
Conclusions:
These findings highlight the importance of continued pharmacovigilance and suggest potential CV safety differences among COVID-19 immunomodulators. Since tocilizumab and baricitinib are similarly indicated for severe patients with COVID-19, further clinical trials are warranted to explore whether tocilizumab represents a safer alternative to baricitinib for these patients. Insights from this study may guide future antiviral repurposing and pandemic preparedness strategies.
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