Considerations for Drug Interactions on QTc Interval in Exploratory COVID-19 Treatment

Roden, Dan M.; Harrington, Robert A.; Poppas, Athena; Russo, Andrea M.

doi:10.1016/j.jacc.2020.04.016

Cited by 72 publications

(59 citation statements)

References 15 publications

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“…TdP, Torsade de pointes findings provide evidence supporting the growing concerns regarding the arrhythmogenic potential of HCQ/CQ treatment. 35,36 Cardiac arrhythmias were reported in 2.4% of the cohort, with bradyarrhythmias the most frequent type, followed by supraventricular arrhythmias and ventricular arrhythmias. Disproportionality analysis demonstrated significantly increased reporting of all cardiac arrythmias following HCQ/CQ treatment compared to the entire database.…”

Section: Major Hcq/cq-associated Cvaementioning

confidence: 99%

Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre‐COVID‐19 reports

Goldman

Bomze

Dankner

et al. 2020

Brit J Clinical Pharma

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There is a clinical need for safety data regarding hydroxychloroquine (HCQ) and chloroquine (CQ) during the coronavirus (COVID-19) pandemic. We analysed realworld data using the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) database to assess HCQ/CQ-associated cardiovascular adverse events (CVAEs) in pre-COVID-19 reports. Methods: We conducted disproportionality analysis of HCQ/CQ in the FAERS database (07/2014-9/2019), using reporting odds ratio (ROR) and the lower bound of the information component 95% credibility interval (IC 025). Results: The full database contained 6 677 225 reports with a mean (±SD) age of 53 (±17) years and 74% females. We identified 4895 reports of HCQ/CQ related adverse events, of which 696 (14.2%) were CVAEs. Compared with the full database, HCQ/CQ use was associated with a higher reporting rate of major CVAEs, including cardiomyopathy (n = 86 [1.8%], ROR = 29.0 [23.3-35.9]), QT prolongation (n = 43 [0.9%], ROR = 4.5 [3.3-6.1]), cardiac arrhythmias (n = 117 [2.4%], ROR = 2.2 [1.8-2.7]) and heart failure (n = 136 [2.8%], ROR = 2.2 [1.9-2.7], all IC₂ > 0). No statistically significant differences were observed between sex and age groups. CVAEs were reported more often in patients with systemic lupus erythematosus and Sjogren's syndrome. HCQ/CQ-associated CVAEs demonstrated subsequent hospitalization and mortality rates of 39% and 8%, respectively. Overdose reports demonstrated an increased frequency of QT prolongation and ventricular arrhythmias (35% and 25%, respectively). Conclusion: In a real-world setting, HCQ/CQ treatment is associated with higher reporting rates of various CVAEs, particularly cardiomyopathy, QT prolongation, cardiac arrhythmias and heart failure. HCQ/CQ-associated CVAEs result in high rates of severe outcomes and should be carefully considered as an off-label indication, especially for patients with cardiac disorders.

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Section: Major Hcq/cq-associated Cvaementioning

confidence: 99%

Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre‐COVID‐19 reports

Goldman

Bomze

Dankner

et al. 2020

Brit J Clinical Pharma

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“…This has occurred despite limited data supporting its efficacy in COVID-19 as well as considerable concern about its safety when used at high doses (>400 mg daily) and in combination with other QT interval prolonging drugs. [1][2][3][4] An inaccurate narrative has emerged in recent weeks that patients with systemic lupus erythematosus (SLE) who are taking HCQ as a baseline therapy are less affected by or do not develop COVID-19. [5][6][7] This assumption has been challenged by Monti and Montecucco, 8 referencing data from the COVID-19 Global Rheumatology Alliance registry on patients with rheumatic disease that previously identified 19/110 (17%) patients with SLE.…”

mentioning

confidence: 99%

Baseline use of hydroxychloroquine in systemic lupus erythematosus does not preclude SARS-CoV-2 infection and severe COVID-19

et al. 2020

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“…In the TRITON-TIMI-38 trial, patients who received thrombolytics were excluded from the trial, thus limited data on T A B L E 1 Summary of the concomitant medications administered with thrombolytics for ST-elevation myocardial infarction (STEMI) suggest alternative therapies. 19 Pharmacists can review the medication profile and recommend discontinuing unnecessary QT prolonging medications to decrease risk. Nurse-driven electrolyte replacement protocols allow for optimization of potassium to greater than 4 mEq/L and magnesium greater than 2 mg/dL to further minimize risk.…”

Section: St-elevation Myocardial Infarctionmentioning

confidence: 99%

“…Nurse-driven electrolyte replacement protocols allow for optimization of potassium to greater than 4 mEq/L and magnesium greater than 2 mg/dL to further minimize risk. 19…”

Section: St-elevation Myocardial Infarctionmentioning

confidence: 99%

COVID‐19 pandemic: Challenges and solutions from the cardiology pharmacist's perspective

Pickworth

Blais

Bagnola

et al. 2020

J Am Coll Clin Pharm

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The recent coronavirus disease 2019 (COVID‐19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) challenges pharmacists worldwide. Alongside other specialized pharmacists, we re‐evaluated daily processes and therapies used to treat COVID‐19 patients within our institutions from a cardiovascular perspective and share what we have learned. To develop a collaborative approach for cardiology issues and concerns in the care of confirmed or suspected COVID‐19 patients by drawing on the experiences of cardiology pharmacists across the country. On March 26, 2020, a conference call was convened composed of 24 cardiology residency‐trained pharmacists (23 actively practicing in cardiology and 1 in critical care) from 16 institutions across the United States to discuss cardiology issues each have encountered with COVID‐19 patients. Discussion centered around providing optimal pharmaceutical care while limiting staff exposure. The collaborative of pharmacists found for the ST‐elevation myocardial infarction patient, many institutions were diverting COVID‐19 rule‐out patients to their Emergency Department (ED). Thrombolytics are an alternative to percutaneous coronary intervention (PCI) allowing for timely treatment of patients and decreased staff exposure. An emergency response grab and go kit includes initial drugs and airway equipment so the patient can be treated and the cart can be left outside the room. Cardiology pharmacists have developed policies and procedures to address monitoring of QT prolonging medications, the use of inhaled prostacyclins, and national drug shortages. Technology has allowed us to practice social distancing, while staying in close contact with our teams, patients, and colleagues and continuing to teach. Residents are engaged in unique decision‐making processes with their preceptors and assist as pharmacist extenders. Cardiology pharmacists are in a unique position to work with other pharmacists and health care professionals to implement safe and effective practice changes during the COVID‐19 pandemic. Ongoing monitoring and adjustments are necessary in rapidly changing times.

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Considerations for Drug Interactions on QTc Interval in Exploratory COVID-19 Treatment

Cited by 72 publications

References 15 publications

Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre‐COVID‐19 reports

Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre‐COVID‐19 reports

Baseline use of hydroxychloroquine in systemic lupus erythematosus does not preclude SARS-CoV-2 infection and severe COVID-19

COVID‐19 pandemic: Challenges and solutions from the cardiology pharmacist's perspective

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