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已发表论文
高龄心房颤动患者中超低剂量利伐沙班的真实世界比较研究
Authors Han D, Ni Q, Qi J , Ni H, Wang B
Received 24 July 2025
Accepted for publication 2 December 2025
Published 9 December 2025 Volume 2025:20 Pages 2467—2480
DOI https://doi.org/10.2147/CIA.S555943
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 5
Editor who approved publication: Dr Maddalena Illario
Dan Han,1 Qian Ni,2 Jialin Qi,2 Huanyu Ni,1 Baoyan Wang1
1Department of Pharmacy, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, People’s Republic of China; 2Department of pharmacy, Nanjing Drum Tower Hospital, Nanjing Drum Tower Hospital Clinical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, People’s Republic of China
Correspondence: Baoyan Wang, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, No. 321 Zhongshan Road, Nanjing, Jiangsu, 210008, People’s Republic of China, Tel +86-15161477178, Email wby6261275@163.com
Background: Optimal dosing of rivaroxaban in very elderly (≥ 80 years) nonvalvular atrial fibrillation (AF) patients remains debated, particularly concerning ultra-low-dose (5 mg daily) regimens derived from clinician judgement. This study aimed to describe real-world comparative outcomes associated with these clinician-selected dosing regimens.
Methods: The study included 1389 very elderly nonvalvular AF patients (≥ 80 years) who received rivaroxaban between January 2018 and December 2022, with 373, 604, and 412 patients receiving 5 mg, 10 mg, and 15/20 mg daily, respectively. Baseline characteristics were balanced using stabilized inverse probability of treatment weighting (IPTW). The outcomes included composite efficacy outcomes (stroke, systemic embolism, myocardial infarction and cardiovascular death) and major bleeding. Subgroup analysis and plasma trough level comparisons were conducted to further assess consistency and pharmacokinetics.
Results: The composite efficacy event rates were 9.3%, 6.6%, and 7.0% for the 5 mg, 10 mg, and 15/20 mg groups, respectively. After IPTW, there was no statistically significant difference in composite efficacy outcomes between three groups (HR for 10 mg vs 5 mg: 0.71, 95% CI: 0.44– 1.15; HR for 15/20 mg vs 5 mg: 0.91, 95% CI: 0.52– 1.59). However, major bleeding occurred in 1.6%, 3.6%, and 6.1% of patients, exhibited a dose-dependent increase. The 15/20 mg group had a 4.27-fold higher risk compared to the 5 mg group (HR: 4.27, 95% CI: 1.66– 10.97), while the 10 mg group showed no significant elevation (HR: 2.11, 95% CI: 0.82– 5.40). Subgroup analysis confirmed consistent efficacy and safety trends across specified subgroups. Plasma trough concentrations were significantly higher in the 15/20 mg group compared to the 5 mg group, with no significant difference between the 10 mg and 5 mg groups.
Conclusion: In very elderly AF patients, ultra-low-dose rivaroxaban (5 mg daily) provided comparable efficacy to higher doses while significantly reducing major bleeding. This regimen may be a balanced option for high-risk elderly populations.
Keywords: atrial fibrillation, very elderly patients, rivaroxaban, ultra-low-dose
1Department of Pharmacy, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, People’s Republic of China; 2Department of pharmacy, Nanjing Drum Tower Hospital, Nanjing Drum Tower Hospital Clinical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, People’s Republic of China
Correspondence: Baoyan Wang, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, No. 321 Zhongshan Road, Nanjing, Jiangsu, 210008, People’s Republic of China, Tel +86-15161477178, Email wby6261275@163.com
Background: Optimal dosing of rivaroxaban in very elderly (≥ 80 years) nonvalvular atrial fibrillation (AF) patients remains debated, particularly concerning ultra-low-dose (5 mg daily) regimens derived from clinician judgement. This study aimed to describe real-world comparative outcomes associated with these clinician-selected dosing regimens.
Methods: The study included 1389 very elderly nonvalvular AF patients (≥ 80 years) who received rivaroxaban between January 2018 and December 2022, with 373, 604, and 412 patients receiving 5 mg, 10 mg, and 15/20 mg daily, respectively. Baseline characteristics were balanced using stabilized inverse probability of treatment weighting (IPTW). The outcomes included composite efficacy outcomes (stroke, systemic embolism, myocardial infarction and cardiovascular death) and major bleeding. Subgroup analysis and plasma trough level comparisons were conducted to further assess consistency and pharmacokinetics.
Results: The composite efficacy event rates were 9.3%, 6.6%, and 7.0% for the 5 mg, 10 mg, and 15/20 mg groups, respectively. After IPTW, there was no statistically significant difference in composite efficacy outcomes between three groups (HR for 10 mg vs 5 mg: 0.71, 95% CI: 0.44– 1.15; HR for 15/20 mg vs 5 mg: 0.91, 95% CI: 0.52– 1.59). However, major bleeding occurred in 1.6%, 3.6%, and 6.1% of patients, exhibited a dose-dependent increase. The 15/20 mg group had a 4.27-fold higher risk compared to the 5 mg group (HR: 4.27, 95% CI: 1.66– 10.97), while the 10 mg group showed no significant elevation (HR: 2.11, 95% CI: 0.82– 5.40). Subgroup analysis confirmed consistent efficacy and safety trends across specified subgroups. Plasma trough concentrations were significantly higher in the 15/20 mg group compared to the 5 mg group, with no significant difference between the 10 mg and 5 mg groups.
Conclusion: In very elderly AF patients, ultra-low-dose rivaroxaban (5 mg daily) provided comparable efficacy to higher doses while significantly reducing major bleeding. This regimen may be a balanced option for high-risk elderly populations.
Keywords: atrial fibrillation, very elderly patients, rivaroxaban, ultra-low-dose