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      Predictors of new oral anticoagulant drug initiation as opposed to warfarin in elderly adults: a retrospective observational study in Southern Italy

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          Abstract

          Aim

          The aim of this study was to assess the predictive role of age, gender, and number and type of co-treatments for new oral anticoagulant (NOAC) vs warfarin prescription in elderly patients naïve for the aforementioned drugs.

          Materials and methods

          Data collected in the period from January 1, 2014, to December 31, 2014, in Caserta Local Health Unit administrative databases (Campania Region, Italy) were screened to identify new users of oral anticoagulants (OACs) who were 75 years or older and whose OAC prescriptions amounted to >90 days of treatment. Age, gender, and number and type of concomitant medications at the time of first OAC dispensation were retrieved. Multivariable logistic regression analysis was used to assess the role of the aforementioned predictors for NOAC initiation as opposed to warfarin.

          Results

          Overall, 2,132 incident users of OAC were identified, of whom 967 met all inclusion criteria. In all, 490 subjects (50.7%) received an NOAC and 477 (49.3%) received warfarin. Age >75 years was positively associated with lower odds of NOAC initiation (OR: 0.969, 95% CI: 0.941–0.998, P=0.038). Similarly, multiple concomitant medication was negatively associated with NOAC initiation compared to warfarin (OR [five to nine drugs] group: 0.607, 95% CI: 0.432–0.852, P=0.004; OR [ten+ drugs] group: 0.372, 95% CI: 0.244–0.567, P<0.001). Prior exposure to platelet aggregation inhibitor drugs was associated with the initiation of NOACs (OR: 3.474, 95% CI: 2.610–4.625).

          Conclusion

          Age and multiple co-medication were negatively associated with NOAC initiation.

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          Most cited references 50

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          Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study.

          Atrial fibrillation is the most common arrhythmia in elderly persons and a potent risk factor for stroke. However, recent prevalence and projected future numbers of persons with atrial fibrillation are not well described. To estimate prevalence of atrial fibrillation and US national projections of the numbers of persons with atrial fibrillation through the year 2050. Cross-sectional study of adults aged 20 years or older who were enrolled in a large health maintenance organization in California and who had atrial fibrillation diagnosed between July 1, 1996, and December 31, 1997. Prevalence of atrial fibrillation in the study population of 1.89 million; projected number of persons in the United States with atrial fibrillation between 1995-2050. A total of 17 974 adults with diagnosed atrial fibrillation were identified during the study period; 45% were aged 75 years or older. The prevalence of atrial fibrillation was 0.95% (95% confidence interval, 0.94%-0.96%). Atrial fibrillation was more common in men than in women (1.1% vs 0.8%; P<.001). Prevalence increased from 0.1% among adults younger than 55 years to 9.0% in persons aged 80 years or older. Among persons aged 50 years or older, prevalence of atrial fibrillation was higher in whites than in blacks (2.2% vs 1.5%; P<.001). We estimate approximately 2.3 million US adults currently have atrial fibrillation. We project that this will increase to more than 5.6 million (lower bound, 5.0; upper bound, 6.3) by the year 2050, with more than 50% of affected individuals aged 80 years or older. Our study confirms that atrial fibrillation is common among older adults and provides a contemporary basis for estimates of prevalence in the United States. The number of patients with atrial fibrillation is likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of elderly individuals. Coordinated efforts are needed to face the increasing challenge of optimal stroke prevention and rhythm management in patients with atrial fibrillation.
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            Increasing prevalence of atrial fibrillation and flutter in the United States.

            The prevalence data for atrial fibrillation (AF) are dated. The present retrospective study estimated the current and projected prevalence of AF and atrial flutter (AFL) in the United States using a large national database. Claims data drawn from July 2004 to December 2005 from the MarketScan research databases from Thomson Reuters were used to identify patients aged >or=20 years with nontransient AF and/or AFL and age- and gender-matched controls without these conditions. Of the 21,648,681 patients in the databases, 242,903 (1.12%) had nontransient AF and/or AFL (222,605 AF only, 5,376 AFL only, and 14,922 AF and AFL). Patients with AF only, AFL only, and AF and AFL had a greater (p <0.001) prevalence of co-morbidities, including hypertension (62.0%, 61.3%, and 57.0%, respectively) and coronary artery disease (43.0%, 44.7%, and 44.5%, respectively), than matched controls (45.1% hypertension and 19.4% coronary artery disease). Applying the US Census Bureau population estimates to the prevalence rates for AF and/or AFL in the databases, it was estimated that 3.03 million persons in the United States had AF only, 0.07 million had AFL only, and 0.19 million had AF and AFL in 2005. The projected prevalence for 2050 was 7.56 million for AF only, 0.15 million for AFL only, and 0.44 million for AF and AFL. In conclusion, the current prevalence of AF and AFL is high and is projected to increase considerably by 2050. The current and projected increases in the prevalence of AF are greater than predicted by a previous sentinel study and might reflect more than the aging of the population.
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              The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy).

              The goal of this study was to analyze the impact of dabigatran plasma concentrations, patient demographics, and aspirin (ASA) use on frequencies of ischemic strokes/systemic emboli and major bleeds in atrial fibrillation patients. The efficacy and safety of dabigatran etexilate were demonstrated in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial, but a therapeutic concentration range has not been defined. In a pre-specified analysis of RE-LY, plasma concentrations of dabigatran were determined in patients treated with dabigatran etexilate 110 mg twice daily (bid) or 150 mg bid and correlated with the clinical outcomes of ischemic stroke/systemic embolism and major bleeding using univariate and multivariate logistic regression and Cox regression models. Patient demographics and ASA use were assessed descriptively and as covariates. Plasma concentrations were obtained from 9,183 patients, with 112 ischemic strokes/systemic emboli (1.3%) and 323 major bleeds (3.8%) recorded. Dabigatran levels were dependent on renal function, age, weight, and female sex, but not ethnicity, geographic region, ASA use, or clopidogrel use. A multiple logistic regression model (c-statistic 0.657, 95% confidence interval [CI]: 0.61 to 0.71) showed that the risk of ischemic events was inversely related to trough dabigatran concentrations (p = 0.045), with age and previous stroke (both p < 0.0001) as significant covariates. Multiple logistic regression (c-statistic 0.715, 95% CI: 0.69 to 0.74) showed major bleeding risk increased with dabigatran exposure (p < 0.0001), age (p < 0.0001), ASA use (p < 0.0003), and diabetes (p = 0.018) as significant covariates. Ischemic stroke and bleeding outcomes were correlated with dabigatran plasma concentrations. Age was the most important covariate. Individual benefit-risk might be improved by tailoring dabigatran dose after considering selected patient characteristics. (Randomized Evaluation of Long Term Anticoagulant Therapy [RE-LY] With Dabigatran Etexilate; NCT00262600). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                2018
                08 October 2018
                : 14
                : 1907-1914
                Affiliations
                [1 ]Center of Pharmacoeconomics (CIRFF), University of Naples Federico II, Naples, Italy, enrica.menditto@ 123456unina.it
                [2 ]Caserta Local Health Unit, Caserta, Italy
                [3 ]Department of Experimental Medicine, Section of Pharmacology, Regional Center of Pharmacovigilance, University of Campania “L. Vanvitelli”, Naples, Italy
                [4 ]Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, DK, Denmark
                Author notes
                Correspondence: Enrica Menditto, CIRFF, Center of Pharmacoeconomics, University of Naples Federico II, Via Domenico Montesano 49, 80131 Naples, Italy, Tel +39 081 167 8660, Fax +39 081 167 8658, Email enrica.menditto@ 123456unina.it
                [*]

                These authors contributed equally to this work

                Article
                tcrm-14-1907
                10.2147/TCRM.S171346
                6183659
                © 2018 Guerriero et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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