دورية أكاديمية
Efficacy and Safety of Different Doses of Rivaroxaban and Risk Factors for Bleeding in Elderly Patients with Venous Thromboembolism: A Real-World, Multicenter, Observational, Cohort Study.
| العنوان: | Efficacy and Safety of Different Doses of Rivaroxaban and Risk Factors for Bleeding in Elderly Patients with Venous Thromboembolism: A Real-World, Multicenter, Observational, Cohort Study. |
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| المؤلفون: | Lu K; Department of Pharmacy, The First Affiliated Hospital of Henan University of Science and Technology, No. 24 Jinghua Road, Jianxi District, Luoyang, China., Liao QQ; Department of Pharmacy, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China., Zhu KW; Office of Pharmacovigilance, GuangZhou BaiYunShan Pharmaceutical Holdings CO., LTD. BaiYunShan Pharmaceutical General Factory, No. 88 Yunxiang Road Tonghe Street, Baiyun District, Guangzhou, 510515, Guangdong Province, China. zhukew2018@outlook.com.; Department of Clinical Pharmacology, Xiangya Hospital, Central South University, No. 110 Xiangya Road, Changsha, China. zhukew2018@outlook.com., Yao Y; Department of Pharmacy, People's Hospital of Ningxia Hui Autonomous Region, Ningxia Medical University, No. 301 Zhengyuan North Street, Jinfeng District, Yinchuan, China., Cui XJ; Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Science and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, No. 32 West Second Section, 1st Ring Road, Qingyang District, Chengdu, China., Chen P; Department of Clinical Pharmacology, Xiangya Hospital, Central South University, No. 110 Xiangya Road, Changsha, China., Bi Y; Department of Pharmacy, Nanchang Hongdu Hospital of TCM, No. 128 Xiangshan North Road, Donghu District, Nanchang, China., Zhong M; Department of Pharmacy, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping Street, Jiangyang District, Luzhou, China., Zhang H; Department of Pharmacy, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China., Tang JC; Administration Office of Medication Clinical Trial, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China., Yu Q; Department of Pharmacy, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China., Yue JK; Department of Pharmacy, The Second Affiliated Hospital of Guilin Medical University, No. 212 Renmin Road, Lingui District, Guilin, China., He H; Department of Pharmacology, Renshou People's Hospital, No. 177, Section 1, Longtan Avenue, Huairen Street, Renshou County, Meishan, China., Zhu ZF; Department of Pharmacy, Affiliated Hospital of Guilin Medical University, No. 15 Lequn Road, Guilin, China., Cai ZZ; Department of Pharmacology, People's Hospital of Qiandongnan Prefecture, No. 31 Shaoshan South Road, Kaili, Qiandongnan Miao and Dong Autonomous Prefecture, China., Yang Z; Department of Pharmacy, North China Medical Health Group Xingtai General Hospital, No. 202 Bayi Street, Xingtai, China., Zhang W; Department of Pharmacy, Yangquan Coal Industry (Group) General Hospital, No. 218 North Street, Mining Area, Yangquan, China.; Department of Pharmacy, The First Affiliated Hospital of Hainan Medical University, No.31 Longhua Road, Longhua District, Haikou, China., Dong YT; Department of Pharmacy, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China., Wei QM; Department of Pharmacy, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China., He X; Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Henan University of Science and Technology, No. 24 Jinghua Road, Jianxi District, Luoyang, 471003, Henan Province, China. hxg7807@sina.com. |
| المصدر: | Advances in therapy [Adv Ther] 2024 Jan; Vol. 41 (1), pp. 391-412. Date of Electronic Publication: 2023 Nov 21. |
| نوع المنشور: | Journal Article; Multicenter Study; Observational Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Health Communications Inc Country of Publication: United States NLM ID: 8611864 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1865-8652 (Electronic) Linking ISSN: 0741238X NLM ISO Abbreviation: Adv Ther |
| أسماء مطبوعة: | Publication: New York : Springer Healthcare Communications, 2008- : Health Communications Inc. Original Publication: Metuchen, N.J. : Health Communications Inc., c1984- |
| مواضيع طبية MeSH: | Pulmonary Embolism*/diagnosis , Pulmonary Embolism*/drug therapy , Venous Thromboembolism*/drug therapy , Venous Thromboembolism*/prevention & control, Aged ; Humans ; Anticoagulants/adverse effects ; Cohort Studies ; Hemorrhage/chemically induced ; Hemorrhage/drug therapy ; Retrospective Studies ; Risk Factors ; Rivaroxaban/adverse effects ; Treatment Outcome |
| مستخلص: | Introduction: Venous thromboembolism (VTE) consists of deep vein thrombosis (DVT) and pulmonary embolism (PE). Rivaroxaban is a direct oral anticoagulant (DOAC) inhibiting activated coagulation factor X (FXa), and exerts several advantages in the treatment of VTE compared to conventional therapy. However, the efficacy and safety of rivaroxaban in elderly patients with VTE was still poorly understood. Methods: The study was carried out using an observational and non-interventional approach. A total of 576 patients aged ≥ 60 years with newly diagnosed VTE were included in the study. All patients received rivaroxaban with recommended treatment duration of ≥ 3 months for secondary prevention. In addition, 535 elderly patients with various diseases except VTE were included in the study in a retrospective and randomized way. Results: The total bleeding rate was 12.2% (70/576). Major bleeding and non-major clinically relevant (NMCR) bleeding occurred in 4 (0.69%) patients and 5 (0.87%) patients, respectively. The rate of recurrent VTE was 5.4%. The mean level of D-dimers was increased by 467.2% in the elderly patients with VTE compared with the elderly patients without VTE. The elderly patients with VTE receiving rivaroxaban at a dose of 10 mg once daily (n = 134) had lower risk for bleeding (3.7% vs 14.7%; P = 0.001) and a similar rate of recurrent VTE (4.5% vs 5.7%; P = 0.596) as compared to the elderly patients with VTE receiving rivaroxaban at higher doses including 15 mg once daily and 20 mg once daily (n = 442). In addition, age, concomitant aspirin, hemoglobin, activated partial thromboplastin time (APTT), and rivaroxaban doses were independent predictive factors for bleeding events. Conclusions: The study suggested that a dose of 10 mg once daily should be the priority in elderly patients with VTE receiving long-term rivaroxaban anticoagulation therapy in view of reduced bleeding risk. (© 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.) |
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| معلومات مُعتمدة: | LHGJ20200577 Health Commission of Henan Province |
| فهرسة مساهمة: | Keywords: Bleeding; Direct oral anticoagulant (DOAC); Elderly patients; Major bleeding; Nomogram; Non-major clinically relevant (NMCR); Older patients; Real-world; Rivaroxaban; Venous thromboembolism (VTE) |
| المشرفين على المادة: | 0 (Anticoagulants) 9NDF7JZ4M3 (Rivaroxaban) |
| تواريخ الأحداث: | Date Created: 20231121 Date Completed: 20240129 Latest Revision: 20240705 |
| رمز التحديث: | 20240706 |
| DOI: | 10.1007/s12325-023-02717-5 |
| PMID: | 37987918 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1865-8652 |
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| DOI: | 10.1007/s12325-023-02717-5 |