(283) Association Between Concomitant Use of Direct Oral Anticoagulants and Statins and Major Bleeding in Patients with Non-valvular Atrial Fibrillation

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 614

Presenting Author(s)

Airam de Burgos Gonzalez
– Agencia Espanola de Medicamentos y Productos Sanitarios-AEMPS, MADRID, Madrid, Spain

Co-Author(s)

Lucía Cea Soriano
– Department of Public Health and Child Health. Faculty of Medicine. Universidad Complutense de Madrid, Spain
Consuelo Huerta
– Assistant Professor Epidemiology and Public Health, Faculty of Medicine. Department of Public Health. Complutense University of Madrid, Spain

Background: A potential interaction mechanism between Direct Oral Anticoagulants (DOACs) and specific statins (Lovastatin, Atorvastatin and Simvastatin) has been described. Despite the widely use of both drugs, there is a need to fill major gaps in this potential interaction.

Objectives: We aimed to estimate the association between concomitant use of DOACs and Statins and the risk of Major Bleeding (MB) using real world evidence data.

Methods: A nested case control study was designed using data from a previous cohort of new users of DOACs, from BIFAP database, within the study period 2008 - 2018. Inclusion criteria were ≥ 18 years old with non-valvular atrial fibrillation (NVAF) and at least 1 years’ registration with the primary care practitioner (PCP). Patients were then followed up until the occurrence of the following endpoints: MB (validated), death, end of the study period or exit from the database. Current users were defined as patients with their last prescription before index date lasting up to 30 days prior; concomitant use was defined as current use of ≥2 drugs. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were estimated with conditional logistic regression for current concomitant users of DOACs and Statins. We performed sensitivity analysis with individual DOACs and with a negative exposure control (other statins with no interaction mechanism described).

Results: Concomitant current use of both DOACs and Statins showed an aOR of MB of 1.65 (95%CI: 1.03-2.64), 2.26 (95%CI: 1.45-3.54) for current use of only DOACs and 1.73 (95%CI: 0.78-03.84) for current use of only Statins. Estimates for individual DOACs in concomitant use with statins were 1.03 (95%CI: 0.67-1.59) for Dabigatran, 0.98 (95%CI: 0.65-1.47) for Apixaban, 1.12 (95%CI: 0.76-1.63) for Rivaroxaban and 2.13 (95%CI: 1.17-3.89) for Edoxaban. There were no significant differences regarding the type of current use (continuous or not). Negative control analysis showed no association between concomitant DOAC and not-interacting-Statins use and MB onset.

Conclusions: DOACs current use is associated with an increased risk of MB, however, this increased risk seems to be unrelated with concomitant use of statins.