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10.1111/bcp.14546

http://scihub22266oqcxt.onion/10.1111/bcp.14546
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32964535!ä!32964535

suck abstract from ncbi


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pmid32964535      Br+J+Clin+Pharmacol 2021 ; 87 (3): 1432-1442
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  • Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre-COVID-19 reports #MMPMID32964535
  • Goldman A; Bomze D; Dankner R; Hod H; Meirson T; Boursi B; Maor E
  • Br J Clin Pharmacol 2021[Mar]; 87 (3): 1432-1442 PMID32964535show ga
  • AIM: There is a clinical need for safety data regarding hydroxychloroquine (HCQ) and chloroquine (CQ) during the coronavirus (COVID-19) pandemic. We analysed real-world 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 IC(0)(2)(5) > 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.
  • |*COVID-19 Drug Treatment[MESH]
  • |*Pharmacovigilance[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Antimalarials/*adverse effects/therapeutic use[MESH]
  • |COVID-19/complications[MESH]
  • |Cardiovascular Diseases/*chemically induced/epidemiology[MESH]
  • |Chloroquine/*adverse effects/therapeutic use[MESH]
  • |Databases, Factual[MESH]
  • |Drug Overdose[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Hydroxychloroquine/*adverse effects/therapeutic use[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Odds Ratio[MESH]


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