1. Use of DOACs in frail elderly patients in light of class genericization.
- Author
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Botto GL, Capranzano P, Colonna P, Fornasari DMM, Sciatti E, and Riva L
- Subjects
- Humans, Aged, Factor Xa Inhibitors therapeutic use, Factor Xa Inhibitors administration & dosage, Female, Male, Aged, 80 and over, Consensus, Italy epidemiology, Stroke, Atrial Fibrillation drug therapy, Frail Elderly, Delphi Technique, Drugs, Generic therapeutic use
- Abstract
Background: Frailty and comorbidity influence the therapeutic approach in everyday clinical practice. The DOACs genericization opens a reflection on their differences from a pharmacological and bioavailability point of view, particularly in elderly frail patients. The aim of this project was to create a national Delphi consensus on the topic of the use of DOACs for atrial fibrillation (AF) in such patients, in light of the genericization of the class., Methods and Results: The consensus dealt with 3 main topics: a) efficacy and safety of DOACs in elderly and/or frail patients; b) therapeutic choice in specific frailty scenarios; c) DOACs genericization. 56 cardiologists, two internists and two neurologists from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1: strongly disagree, 2: disagree, 3: uncertain, 4: agree, 5: strongly agree). A positive consensus was reached if the percentage of agreement (vote 1-2, positive consensus) or disagreement (votes 4-5, negative consensus) was >66%; otherwise, no consensus was reached. Results are displayed accordingly., Conclusions: After 10 years of everyday clinical management of DOACs for AF, specific elements differentiating a molecule from another, either for efficacy or for safety, are consolidated. However, some uncertainties still exist in particular contexts, such as chronic kidney disease or cancer patients. Clinicians have an unsure attitude towards generic drugs, because clinical practice is lacking as well as a proper knowledge of the topic. Albeit being an alternative, the choice of the generic drug must remain the responsibility of the clinician., Competing Interests: Declaration of competing interest GLB declared speaker fees (small amount) from Bayer Healthcare, Boheringer, Daiichi-Sankyo, Pfizer/BMS, Sanofi. PCa has nothing to declare. PCo participates in Daiichi Sankyo, Inc.-funded research; is a coauthor of ESC guidelines on AF (versions 2010 and 2012) and received institutional research grants from Bayer, Boehringer, and Daiichi Sankyo, Inc.; and speaker honoraria from Bayer, Boehringer Ingelheim, Pfizer-BMS, and Daiichi Sankyo, Inc. In the last two years DMMF has received fees for partecipations as expert in Advisory Boards or as speaker in Congress and meeting or as consultant, from the following companies: Abiogen, Alfasigma, Angelini, Agave, Bayer, Daiichi-Sankyo, Grunenthal, Janssen, Lundbeck, Molteni, Sandoz, SPA, Zambon. ES has nothing to declare. LR is a speaker and a scientific research partner for Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo; no fees are directly received personally., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
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