Influence of Concomitant Treatments under Anticoagulants and Statins in Detecting Signals of Adverse Drug Reactions

Abstract

The aim of the present study was to evaluate the risk of adverse drug reactions (ADRs) of concomitant treatments in patients treated with anticoagulants and statins. The authors performed an observational cross-sectional study in two cohorts of surveyed patients treated with vitamin K antagonists (VKAs) or non–vitamin K antagonist oral anticoagulants (NOACs). Different groups were analyzed based on the drug that each patient was taking, that is, VKAs or NOACs, as well as on the use of HMG CoA reductase inhibitors (statins) versus nonuse of these drugs; they also took into account the potential exposure to other common medications. Descriptive, clinical, and ADR data were reported and analyzed through an adaptation of Bayesian methodology (false discovery rate < 0.05) to detect new signals. Eleven different ADRs in patients on VKAs and statins and 12 in patients on VKAs without statins were found. In evaluating the concomitant therapies, the authors found that analgesics and nonsteroidal anti-inflammatory drugs were the most common therapeutic options, followed by proton pump inhibitors (PPIs). Seven ADRs were observed in patients concomitantly treated with NOACs and statins, whereas NOACs without concomitant statins were associated with a significantly lower risk of bleeding. The risk of observing an ADR among the patients who are concomitantly treated with VKAs and statins is lower than with analgesics or PPI, while the concomitant use of NOACs and statins is associated with both an increment in the number of observed ADRs and increased risk of bleeding.

Concurrent use of statins decreases major bleeding and intracerebral hemorrhage in non-valvular atrial fibrillation patients taking direct oral anticoagulants—A nationwide cohort study

“…Reviewing the literature, only a few studies evaluated the risk of major bleeding in AF patients receiving statins and long-term anticoagulant therapy. Evidence shows that concurrent use of statins and VKA (warfarin) did not increase the risk of bleeding, but data with simultaneous DOACs and statins use was controversial ( 26 , 27 ). An earlier study reported a higher ICH risk in patients taking dabigatran and either simvastatin or lovastatin ( 17 ).…”

“…An earlier study reported a higher ICH risk in patients taking dabigatran and either simvastatin or lovastatin ( 17 ). One observational study also suggested an increased bleeding risk with simultaneous use of DOACs and statins ( 27 ). On the other hand, a nationwide study from Taiwan found reduced major bleeding events with concurrent use of atorvastatin and DOACs ( 16 ).…”

Early Signal Detection: Data Mining of Mental Disorders with Statins

“…In this case, only the chemical subgroup C10AA "HMG CoA reductase inhibitors" [16] was considered in the analysis. This methodology approach has previously demonstrated robustness and consistency when all the ADR databases were applied to a specific group of drugs [17][18][19]. Details of the algorithm performed are reported (see Appendix 1).…”

Statin-Associated Liver Dysfunction and Muscle Injury: epidemiology, Mechanisms, and Management Strategies

“…Besides, in patients who used both vitamin K antagonists and statins, the risk of ADR observed was lower than that of concomitant treatment with non-vitamin K antagonist oral anticoagulants and statins in an observational cross-sectional study. 26 Fourthly, a history of liver and biliary diseases should be checked before using statins. If the liver transaminase is elevated, differential diagnosis and treatment should be performed, and statins should be started after the transaminase has returned to normal.…”