Abstract
In light of the favorable outcomes of few small, non-randomized clinical studies, the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to Hydroxychloroquine (HCQ) for hospitalized coronavirus disease 2019 (COVID-19) patients. In fact, subsequent clinical studies with COVID-19 and HCQ have reported limited efficacy and poor clinical benefits. Unfortunately, a robust clinical trial for its effectiveness is not feasible at this emergency. Additionally, HCQ was suspected of causing cardiovascular adverse reactions (CV-AEs), but it has never been directly investigated. The objective of this pharmacovigilance analysis was to determine and characterize HCQ-associated cardiovascular adverse events (CV-AEs). We performed a disproportionality analysis of HCQ-associated CV-AEs using the FDA adverse event reporting system (FAERS) database. The FAERS database, comprising more than 11,901,836 datasets and 10,668,655 patient records with drug-adverse reactions, was analyzed. The disproportionality analysis was used to calculate the reporting odds ratios (ROR) with 95% confidence intervals (CI) to predict HCQ-associated CV-AEs. HCQ was associated with higher reporting of right ventricular hypertrophy (ROR: 6.68; 95% CI: 4.02 to 11.17), left ventricular hypertrophy (ROR: 3.81; 95% CI: 2.57 to 5.66), diastolic dysfunction (ROR: 3.54; 95% CI: 2.19 to 5.71), pericarditis (ROR: 3.09; 95% CI: 2.27 to 4.23), torsades de pointes (TdP) (ROR: 3.05; 95% CI: 2.30 to 4.10), congestive cardiomyopathy (ROR: 2.98; 95% CI: 2.01 to 4.42), ejection fraction decreased (ROR: 2.41; 95% CI: 1.80 to 3.22), right ventricular failure (ROR: 2.40; 95% CI: 1.64 to 3.50), atrioventricular block complete (ROR: 2.30; 95% CI: 1.55 to 3.41) and QT prolongation (ROR: 2.09; 95% CI: 1.74 to 2.52). QT prolongation and TdP are most relevant to the COVID-19 treatment regimen of high doses for a comparatively short period and represent the most common HCQ-associated AEs. The patients receiving HCQ are at higher risk of various cardiac AEs, including QT prolongation and TdP. These findings highlight the urgent need for prospective, randomized, controlled studies to assess the risk/benefit ratio of HCQ in the COVID-19 setting before its widespread adoption as therapy.
Highlights
We are amidst the global coronavirus disease 2019 (COVID-19) pandemic caused by the novel severe acute respiratory syndrome (SARS)-like coronavirus (SARS-CoV-2) [1]
To fill the gap between HCQ-mediated cardiotoxicities and how it could affect during COVID-19 treatment, we performed a search query for all Standardized MedDRA Queries (SMQs) associated with HCQ versus the entire database since its Food and Drug Administration (FDA) approval from 1998 to 2019
HCQ was associated with higher reporting of cardiomyopathy, as depicted by elevated reporting odds ratio (ROR) (3.04, 95% confidence intervals (CI): 2.69 to 3.44)
Summary
We are amidst the global coronavirus disease 2019 (COVID-19) pandemic caused by the novel severe acute respiratory syndrome (SARS)-like coronavirus (SARS-CoV-2) [1]. This global pandemic is a serious threat to public health and economic stability. The staggering scale of this disease is an undisputed fact This is evident by more than 6.7 million confirmed cases and over 397,388 deaths worldwide [2]. As of the first week of June 2020, more than 2 million infections and 112,549 deaths have been confirmed in the USA alone. Once the patient develops severe respiratory complications, and need intensive care and mechanical respiratory assist device (ventilator), the fatality rates goes up to 40–60%
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