Hemorrhage Risk Profiles among Different Antithrombotic Regimens: Evidence from a Real-World Analysis of Postmarketing S
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ORIGINAL ARTICLE
Hemorrhage Risk Profiles among Different Antithrombotic Regimens: Evidence from a Real-World Analysis of Postmarketing Surveillance Data Xue Sun 1 & Bi Ze 1 & Ling-Jun Zhang 2 & Yang-Zhong BaiMa 1 & Wei Zuo 3 & Bin Zhao 1,3 & Luo-Bo GeSang 2 Accepted: 10 November 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background Although the use of direct oral anticoagulants (DOACs) has been reported in patients with atrial fibrillation (AF), there is currently no consensus on the occurrence or characteristics of the hemorrhage risk in different antithrombotic regimens. Methods Disproportionality and Bayesian analyses were performed in mining data of suspected hemorrhagic events after antithrombotic drug use from the FDA Adverse Event Reporting System (FAERS) from January 2004 to September 2019. The time to onset and fatality rate of hemorrhage following different antithrombotic regimens were also compared. Results A total of 84,998 reports of hemorrhage-related adverse events with the use of antithrombotic drugs were identified. The patients included were mostly from the Americas (80.87%) and Europe (13.22%), with most data submitted by nonhealthcare professionals. Among the seven antithrombotic drug monotherapies, betrixaban had the highest association with hemorrhage based on the highest reporting odds ratio (ROR, 829.95; 95% CI = 113.61-6063.15), proportional reporting ratio (PRR, 24.68, χ2 = 804.24), and multi-item gamma Poisson shrinker (MGPS, 24.68, 95% one-sided CI = 4.67). The combination therapies of clopidogrel plus new oral anticoagulants had higher RORs, PRRs, and empirical Bayesian geometric means (EBGMs) than the antithrombotic drug monotherapies. Hemorrhage associated with rivaroxaban plus clopidogrel appeared to have an earlier onset (171 days vs 219 days, 95% two-sided CI =68.68-27.34, p < 0.0001) and a lower fatality rate (15.30% vs 17.74%, p 0 EBGM05 > 2,N > 0
a, the number of reports with suspect ADRs of the suspect drug; b, the number of reports with the suspect ADRs of all other drugs; c, the number of reports with all other ADRs of the suspect drug; d, the number of reports with all other ADRs of all other drugs ROR reporting odds ratio, CI confidence interval, N the number of co-occurrences, PRR proportional reporting ratio, χ2 chi-squared, BCPNN Bayesian confidence propagation neural network, IC information component, IC025 the lower limit of the 95% two-sided CI of the IC, MGPS multi-item gamma Poisson shrinker, EBGM empirical Bayesian geometric mean, EBGM05 the lower 95% one-sided CI of EBGM
Cardiovasc Drugs Ther Table 3 Clinical characteristics of patients with bleeding collected from the FAERS database (January 2000 to September 2019) Characteristics Reporting region Europe Oceania Americas Asia Africa Unknown or missing Reporters Health-care professional Non-health-care professional Reporting year 1998-2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Unknown or missing Patient sex Female Male Unk
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