Hydroxychloroquine, QTc prolongation and risk of torsades de pointes

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Abstract

Hydroxychloroquine (HCQ) is a common medication used for the treatment of rheumatic diseases. As a result of its widespread use during COVID-19, there are increasing concerns about its cardiotoxicity. HCQ is known to cause QTc prolongation, and its long-term use has been associated with cardiomyopathy and conduction abnormalities. Despite reports of ventricular arrhythmia in COVID-19 patients taking HCQ, there have been reassuring data in approved indications. HCQ has been in use for several decades with a good safety profile. In addition to better disease control and prevention of flares, it is associated with decreased risk of cardiovascular diseases. But given its small risk of cardiotoxicity, clinicians should be aware of this effect and monitor patients for developing cardiac symptoms.

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A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19

David Boulware, Matthew Pullen, Ananta Bangdiwala … (2020)

Abstract Background Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown. Methods We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days. Results We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage points (95% confidence interval, −7.0 to 2.2; P=0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. Conclusions After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.)

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Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Alexandre B Cavalcanti, Fernando Zampieri, Regis Rosa … (2020)

Abstract Background Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited. Methods We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed. Results A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent. Conclusions Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.)

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Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19

Mark Peters (2020)

Abstract Background Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials. Methods In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality. Results The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P=0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine. Conclusions Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.)

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Journal

Journal ID (nlm-ta): Arch Med Sci Atheroscler Dis

Journal ID (iso-abbrev): Arch Med Sci Atheroscler Dis

Journal ID (publisher-id): AMS-AD

Title: Archives of Medical Sciences. Atherosclerotic Diseases

Publisher: Termedia Publishing House

ISSN (Electronic): 2451-0629

Publication date (Electronic): 17 August 2023

Publication date Collection: 2023

Volume: 8

Pages: e75-e80

Affiliations

[1 ]Departments of Medicine, Westchester Medical Center and New York Medical College, Valhalla, NY, USA

[2 ]Departments of Cardiology, Westchester Medical Center and New York Medical College, Valhalla, NY, USA

Author notes

Corresponding author: Sarah Subhan, Department of Medicine Westchester Medical Center and New York Medical College Valhalla, NY, USA. Phone: 9145272892. E-mail: sarah.subhan@ 123456wmchealth.org

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Publisher ID: 169982

DOI: 10.5114/amsad/169982

PMC ID: 10711783

PubMed ID: 38089162

SO-VID: cffdbf7f-6807-4dea-adb8-a0587faf5656

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This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.

Hydroxychloroquine, QTc prolongation and risk of torsades de pointes

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Novel Coronavirus Disease COVID-19

Most cited references 52

A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19

Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19

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