Use of DOACs in frail elderly patients in light of class genericization.

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.