(227) Comparison of Hemorrhagic Profile Amongst Direct Acting Oral Anti-Coagulants (DOACs): Risk Quantification by Using US FDA Adverse Event Reporting System (FAERS)

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1272

Presenting Author(s)

Pudi Chiranjeevi, PharmD
– M S Ramaiah University Of Applied sciences, Bengaluru, Karnataka, India

Co-Author(s)

Saraswathy G R
– M S Ramaiah University of Applied Sciences, Karnataka, India
Subeesh Kulangara Viswam, MPharm
– Assistant Professor, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Udupi, Karnataka, India
Ann Mary Swaroop
– M S Ramaiah University of Applied Sciences, Karnataka, India

Background: Hemorrhage or bleeding is the common manifestation with anti-coagulant therapy. Risk quantification of hemorrhagic profile is essential with extensive use of Direct acting Oral Anti-coagulants (DOACs).

Objectives: The main objective of this study is to quantify the risk of bleeding associated with DOACs via disproportionality analysis in US FDA Adverse Event Reporting System (FAERS).

Methods: The analysis had been carried out by extracting FAERS data pertinent to hemorrahgic events linked with DOACs between October 2010 to September 2020. Disproportionality analysis was performed based on Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) with 95% confidence intervals (CI). The Preferred Terms (PT) such as “Bleed”, “Bleeding”, “Hemorrhage” and “Haemorrhage” were used to search the event of interest. OpenVigil 2.1 was adopted for data retrieval and analysis.

Results: A total of 48,425 reports have been identified in the FDA database for PTs. Amongst which 11,166 (23.05%) reports were on DOACs with Rivaroxaban (12.23%) sharing the maximum percentage followed by Apixaban (5.56%), Dabigatran (5.07%) and Edoxaban (0.17%). DOACs with the highest risk estimates were Rivaroxaban (ROR 13.19, 95% CI 12.82-13.56; PRR 12.49, 95% CI 12.16‐12.82), Dabigatran (ROR 9.9, 95% CI 9.5-10.32; PRR 9.48, 95% CI 9.11‐9.87) followed by Apixaban (ROR 6.86, 95% CI 6.60-7.14; PRR 6.67, 95% CI 6.42‐6.93). Edoxaban exhibited least risk (ROR 4.31, 95% CI 3.47-5.34; PRR 4.23, 95% CI 3.46‐5.34). The ROR and PRR were recalculated after removing the concomitant co-administered drugs with DOACs and the signal strength was found to be significant.

Conclusions: Among DOACs, Rivaroxaban displayed higher risk of hemorrhage followed by Dabigatran, Apixaban and Edoxaban. This study may assist the medical professionals to select an appropriate anti-coagulant base on their hemorrhagic risk profile.