Abstract:
INTRODUCTION:The standard dabigatran etexilate dosage for prevention of venous thromboembolism (VTE) after elective total hip or knee replacement (THR/TKR) is 220mg once daily (qd), with 150mg qd for patients with moderate renal impairment. As clinical trial experience in patients with moderate renal impairment was limited at the time of approval, we conducted an observational study to evaluate the 150mg qd dose. MATERIALS AND METHODS:This open-label, prospective, uncontrolled, observational study in patients with creatinine clearance (CrCl) 30-50mL/min was conducted in seven European countries. Patients received 75mg dabigatran etexilate 1-4h after surgery and 150mg qd on days 2-10 (TKR) or 2-35 (THR), per the European Summary of Product Characteristics. Coprimary outcomes were major bleeding events (MBEs) and a composite of symptomatic VTE and all-cause mortality. RESULTS:428 renally impaired patients with median CrCl 43.4mL/min (range 30.0-49.9), and median age 80years (range 32-96) received dabigatran etexilate: median treatment duration THR 31days, TKR 28days. Ten MBEs occurred in nine patients (2.1%; 95% confidence interval [CI]: 1.0-4.0; THR 1.8%; TKR 2.4%); none were fatal or involved a critical organ. Symptomatic VTE and all-cause mortality occurred in three patients (0.7%; 95% CI: 0.1-2.0; THR 0.9%; TKR 0.5%). Overall, 54 patients discontinued treatment prematurely, including 35 due to an adverse event (nine bleeding-related) and 16 switching to another anticoagulant. CONCLUSIONS:Dabigatran etexilate 150mg qd had a good safety profile and was efficacious in fragile, elderly, renally impaired patients undergoing THR or TKR. These findings from the clinical practice setting add to the existing clinical trial data.
journal_name
Thromb Resjournal_title
Thrombosis researchauthors
Samama CM,Rosencher N,Kleine E,Feuring M,Brueckmann M,Clemens A,Gullberg J,Frostick SPdoi
10.1016/j.thromres.2016.05.014subject
Has Abstractpub_date
2016-07-01 00:00:00pages
103-10eissn
0049-3848issn
1879-2472pii
S0049-3848(16)30350-4journal_volume
143pub_type
临床试验,杂志文章abstract::The variant von Willebrand disease (vWd) variant type 2M (Vicenza) was identified in 13 patients of 7 unrelated families. 11 patients were from different parts of germany and 2 patients from Turkey. Hitherto this variant of vWd has been described only in two families originating from the province of Vicenza in Norther...
journal_title:Thrombosis research
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doi:10.1016/s0049-3848(97)00104-7
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journal_title:Thrombosis research
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journal_title:Thrombosis research
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doi:10.1016/0049-3848(89)90235-1
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journal_title:Thrombosis research
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journal_title:Thrombosis research
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doi:10.1016/0049-3848(88)90020-5
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journal_title:Thrombosis research
pub_type: 杂志文章,评审
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journal_title:Thrombosis research
pub_type: 杂志文章,随机对照试验
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journal_title:Thrombosis research
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2015.10.035
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journal_title:Thrombosis research
pub_type: 杂志文章
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journal_title:Thrombosis research
pub_type: 临床试验,杂志文章
doi:10.1016/j.thromres.2005.10.008
更新日期:2006-01-01 00:00:00
abstract::Protein C (PC) is the central protein in a major antithrombotic regulatory mechanism. Hereditary deficiencies of PC are associated with thrombosis. Therapeutic PC replacement may be an important treatment if pure functional human protein C is available in sufficient quantity. Human PC has been produced on a commercial...
journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(90)90258-e
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journal_title:Thrombosis research
pub_type: 临床试验,杂志文章
doi:10.1016/j.thromres.2004.05.005
更新日期:2004-01-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/j.thromres.2007.12.023
更新日期:2008-01-01 00:00:00
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2003.12.005
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2010.05.011
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doi:10.1016/0049-3848(94)90154-6
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journal_title:Thrombosis research
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doi:10.1016/0049-3848(90)90216-y
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journal_title:Thrombosis research
pub_type: 杂志文章
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2012.04.009
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(83)90216-5
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(92)90047-e
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/0049-3848(90)90268-h
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journal_title:Thrombosis research
pub_type: 临床试验,杂志文章
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journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2007.09.008
更新日期:2008-01-01 00:00:00
abstract:INTRODUCTION:Aspirin inhibits the cyclooxygenase-1 (COX-1) mediated thromboxane A2 synthesis. Despite COX-1 inhibition, in patients with coronary artery disease (CAD), platelets can be activated through other mechanisms, like activation by thrombin. MATERIALS AND METHODS:At baseline in this cross-sectional substudy of...
journal_title:Thrombosis research
pub_type: 杂志文章
doi:10.1016/j.thromres.2012.06.016
更新日期:2012-09-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/0049-3848(92)90130-3
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