Int. Journal of Clinical Pharmacology and Therapeutics, Volume 64 (2026) - January (18 - 27)

Analysis of the clinical characteristics and risk factors for dabigatran-induced bleeding in patients with nonvalvular atrial fibrillation

Xiaojuan Wang, Xiaoying Wang, Ya Li, Zhenfeng Yang, Dong Wu
Department of Pharmacy, Fuyang People’s Hospital, Fuyang, Anhui, China

Add to Cart  

 

DOI 10.5414/CP204807

Abstract

Objective: To explore the clinical characteristics of dabigatran-induced bleeding and analyze its risk factors in patients with nonvalvular atrial fibrillation (NVAF).
Materials and methods: A retrospective analysis was conducted on patients with NVAF who received 110 mg of dabigatran twice daily from January 2020 to March 2023. Patients were divided into a long-term-use group and a first-time-use group on the basis of their duration of medication use. The impact of long-term dabigatran use on coagulation function was analyzed. Furthermore, patients in the long-term-use group were divided into bleeding and nonbleeding subgroups. Multivariate logistic regression analysis was used to determine the risk factors for bleeding. Clinical data such as underlying diseases, concomitant medications, bleeding types, and bleeding sites were collected.
Results: A total of 531 cases were collected, including 214 in the long-term-use group and 317 in the first-time-use group. In addition to fibrinogen (p > 0.05), coagulation function indicators, including the prothrombin time, prothrombin time percentage, international normalized ratio, activated partial thromboplastin time, and thrombin time (TT), were greater in the long-term-use group than in the first-time-use group, whereas D-dimer values were significantly lower in the long-term-use group (p < 0.05). A total of 63 bleeding cases were found, with an overall bleeding rate of 11.86%. The bleeding type was BARC type 1 (87.30%), and the bleeding site was mainly gastrointestinal bleeding (77.78%). Multivariate logistic regression analysis revealed that a TT value > 116 s (OR 0.385, 95% CI 0.150 – 0.984; p = 0.038) and the presence of heart failure (OR 0.341, 95% CI 0.133 – 0.875; p = 0.025) were risk factors for bleeding in patients on long-term dabigatran therapy.
Conclusion: The probability of bleeding caused by long-term use of dabigatran is relatively high, but it is mainly minor bleeding. The long-term use of dabigatran has an impact on multiple coagulation function indicators. Clinical physicians and pharmacists need to closely monitor patients’ TT values and whether they have heart failure and identify high-risk populations for bleeding as early as possible.

Author Details

Authors

Departments

  • Department of Pharmacy, Fuyang People’s Hospital, Fuyang, Anhui, China

Address

Dong Wu, MD
Department of Pharmacy
Fuyang People’s Hospital
Fuyang, 236000, Anhui, China
Email: [email protected]

Citation

Xiaojuan Wang, Xiaoying Wang, Ya Li, Zhenfeng Yang, Dong Wu.Analysis of the clinical characteristics and risk factors for dabigatran-induced bleeding in patients with nonvalvular atrial fibrillation
. Int J Clin Pharmacol Ther. 2026; 64: 18-27. doi: 10.5414/CP204807. Pubmed: https://pubmed.ncbi.nlm.nih.gov/41122012/; PMID: 41122012.

###article_not_exists_msg###

Shopping Overview

Shopping Overview
Type Qtty Discount VAT Price
Your basket is empty
View Cart