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Assessment of QT Intervals in a Case Series of Patients With Coronavirus Disease 2019 (COVID-19) Infection Treated With Hydroxychloroquine Alone or in Combination With Azithromycin in an Intensive Care Unit
Bessière et al., JAMA Cardiol., May 1, 2020, doi:10.1001/jamacardio.2020.1787
Bessière et al., Assessment of QT Intervals in a Case Series of Patients With Coronavirus Disease 2019 (COVID-19) Infection.., JAMA Cardiol., May 1, 2020, doi:10.1001/jamacardio.2020.1787
May 2020   Source   PDF  
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Study of 40 very serious condition ICU patients, 75% required invasive mechanical ventilation, 63% received vasoactive drugs, 50% received other treatments favoring QT prolongation. HCQ with or w/o AZ was given to 45% and 55% respectively. They showed an increase in QTc, more significant with the combination of HCQ+AZ where prolonged QTc was observed in 36% (10 with ΔQTc >60 milliseconds and 7 with QTc ≥500 milliseconds). No ventricular arrhythmia, including torsades de pointes, was recorded. While these results may not be generalizable outside the ICU, caution is recommended in use, especially with the combination.
Appropriate use and careful analysis of contraindications, risks, and benefits are important. More recent and much larger studies have not shown significant safety concerns, including outpatient RCTs showing no serious adverse events, and even the RECOVERY trial which used an unusually high dose of HCQ (including 237 patients also receiving AZ) reports they "did not show any excess in ventricular tachycardia (including torsade de pointes) or ventricular fibrillation in the hydroxychloroquine arm", and "serious cardiovascular toxicity has been reported very rarely despite the high prevalence of cardiovascular disease in hospitalized patients, the common occurrence of myocarditis in COVID-19, and the extensive use of hydroxychloroquine and azithromycin together."
Bessière et al., 1 May 2020, peer-reviewed, 7 authors.
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Abstract: Letters Figure. Tafamidis Out-of-Pocket Costs 70 Out-of-pocket cost before financial assistance Out-of-pocket cost after financial assistance Patients receiving tafamidis, % 60 50 1. Maurer MS, Schwartz JH, Gundapaneni B, et al; ATTR-ACT Study Investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. doi:10.1056/ NEJMoa1805689 2. US Food and Drug Administration. Vyndaquel & Vyndamax (tafamidis). Accessed April 1, 2020. 2019/211996Orig1s000,%20212161Orig1s000TOC.cfm 3. Gurwitz JH, Maurer MS. Tafamidis—a pricey therapy for a not-so-rare condition. JAMA Cardiol. Published online January 8, 2020. doi:10.1001/ jamacardio.2019.5233 40 30 4. Kazi DS, Bellows BK, Baron SJ, et al. Cost-effectiveness of tafamidis therapy for transthyretin amyloid cardiomyopathy. Circulation. 2020;141(15):1214-1224. doi:10.1161/CIRCULATIONAHA.119.045093 20 10 0 0 1-100 101-1000 1001-2000 >2000 5. Office of Inspector General. Publication of OIG special advisory bulletin on patient assistance programs for Medicare Part D enrollees. Fed Regist. 2005;70 (224):70623. PAPAdvisoryBlletinFinal-Final.pdf Cost bracket, $ Distribution of tafamidis out-of-pocket costs for all patients before any assistance programs were applied to and after 28 patients (56%) received financial assistance. program, a specialty pharmacy, and a dedicated pharmacist who spent an average of 1 hour per patient to ensure they can afford tafamidis. As such, our experience might not be easily applicable to other health care settings. Ahmad Masri, MD, MS Hongya Chen, PharmD Catherine Wong, MD Katherine L. Fischer, MSN, RN Chafic Karam, MD Walid F. Gellad, MD, MPH Stephen B. Heitner, MD Author Affiliations: The Knight Cardiovascular Institute, Oregon Health & Science University, Portland (Masri, Chen, Wong, Fischer, Heitner); Oregon Health & Science University Amyloidosis Center, Portland (Masri, Chen, Wong, Fischer, Karam, Heitner); Department of Neurology, Oregon Health & Science University, Portland (Karam); Center for Pharmaceutical Policy and Prescribing, Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (Gellad). Accepted for Publication: April 2, 2020. Corresponding Author: Ahmad Masri, MD, MS, Oregon Health and Science University, 3181 SW Sam Jackson Rd, Mail Code: UHN-62, Portland, OR 97239 ( Published Online: June 17, 2020. doi:10.1001/jamacardio.2020.1738 Author Contributions: Dr Masri had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Masri, Wong, Heitner. Acquisition, analysis, or interpretation of data: Masri, Chen, Fischer, Karam, Gellad, Heitner. Drafting of the manuscript: Masri, Heitner. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: Masri, Heitner. Administrative, technical, or material support: Masri, Chen, Fischer, Karam, Heitner. Supervision: Masri, Chen, Heitner. Conflict of Interest Disclosures: Dr Masri reported grants from Pfizer and Akcea outside the submitted work. Dr Heitner reported grants and personal fees from Pfizer, Eidos , Ionis, and Akcea during the conduct of the study and grants and personal fees from Pfizer, Eidos, Ionis, and Akcea outside..
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