Real-World Comparison of Inpatient Bleeding Risk, Bleeding-Related Hospitalization Rates and Costs Among Non-Valvular Atrial Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban: Cohorts Comprising New Initiators and/or Switchers From Warfarin

Tepper, Ping G.; Mardekian, Jack; Masseria, Cristina; Horblyuk, Ruslan; Kamble, Shital; Hamilton, Melissa; Abdulsattar, Younos; Petkun, William; Lip, Gregory Y.H.

doi:10.1016/s0735-1097(16)30663-5

Cited by 9 publications

(7 citation statements)

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“…Post marketing studies on DOAC therapy have yielded some data similar to the clinical trial results [22,23]. The hemorrhagic incidence reported in this study in patients with prolonged PTT during DOAC therapy may not reflect the hemorrhagic incidence in all patients with DOAC therapy.…”

Section: Discussionsupporting

confidence: 53%

Bleeding Complications in Patients Receiving Direct Oral Anticoagulant Therapy in the Post Clinical Trial General Practice

Edupuganti¹

2017

AJCEM

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Dabigatran, apixaban and rivaroxaban are direct oral anticoagulants (DOACs) recently approved for patients with venous thromboembolism. Therapy-induced hemorrhage remains a major complication in these patients. This study retrospectively reviews the hemorrhagic complications associated with DOACs in the general practice and the related clinical implications. The electronic medical charts of 2255 patients with prolonged PTT tests during August 2015 to April 2016 at William Beaumont Health System -Troy were retrospectively reviewed. Patients with prolonged PTT and simultaneously receiving DOAC's were identified. Hemorrhagic complications associated with DOAC therapy and the related clinical information were analyzed. 517 (22.9%) patients were identified receiving DOAC therapy. Among these, DOAC therapyassociated hemorrhages were recorded in 85 patients (16.4%). Apixaban had a significantly lower incidence of hemorrhage (8.8%) than rivaroxaban (21.0%) and dabigatran (27.9%). The most common hemorrhage was GI bleeding (7.0% overall); its incidence was significantly higher in dabigatran (18.6%) than apixaban (4.1%) and rivaroxaban (7.4%); but no significant difference between apixaban and rivaroxaban (p>0.05). GI bleeding produced anemia in 13 patients who received additional treatments with occasional blood transfusions. Since GI bleeding is the most common bleeding complication and may cause anemia in patients receiving DOAC therapy, routine studies for GI bleeding should be encouraged to reduce the complications of GI bleeding. Apixaban has significantly lower incidence of bleeding complications, it may be a better choice in patients with increased bleeding risk overall. However, apixaban may not improve the bleeding risk in patients with GI bleeding associated with rivaroxaban.

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Section: Discussionsupporting

confidence: 53%

Bleeding Complications in Patients Receiving Direct Oral Anticoagulant Therapy in the Post Clinical Trial General Practice

Edupuganti¹

2017

AJCEM

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“…Recently, a group of researchers presented abstracts at the 2015 European Society of Cardiology meeting from 3 observational studies comparing bleeding outcomes with apixaban vs dabigatran, rivaroxaban, or warfarin [23][24][25]. In the first, using data from the MarketScan Early View health insurance claims database, they evaluated major bleeding in 60,277 patients with NVAF (n = 8785 apixaban, n = 20,963 dabigatran, and n = 30,529 rivaroxaban) [24]. They reported that rivaroxaban increased the risk for major bleeding (adjusted HR 1.36; 95% CI, 1.23-1.52) compared with apixaban, while dabigatran had a risk similar to that of apixaban for major bleeding (adjusted HR 0.99; 95% CI, 0.88-1.10).…”

Section: All Doacsmentioning

confidence: 99%

Safety of direct oral anticoagulants: insights from postmarketing studies

Villines

Peacock

2016

The American Journal of Emergency Medicine

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Direct oral anticoagulants (DOACs) have been marketed in the United States since 2010. While numerous large-scale prospective phase 3 outcomes studies have documented the effectiveness of DOACs for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, the primary safety concern with all of these drugs-as it is with the more established oral anticoagulant warfarin-is the risk of major bleeding. Postmarketing surveillance studies (PMSS) provide the opportunity to evaluate the safety of these recently approved drugs across a spectrum of patients that may be broader than those included in randomized controlled trials. This review will summarize the safety findings of numerous recently performed, large-scale PMSS evaluations, and consider the currently available evidence regarding the risks for bleeding in patients treated with DOACs, in order to give providers and patients additional evidence regarding the safety of DOACs.

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“…This yielded adjusted hazard ratios (HRs), referenced to warfarin, of 0.53 (0.29-0.97), 0.82 (0.58−1.16) and 1.08 (0.85−1.39) for apixaban, DAB and rivaroxaban, respectively [Kamble et al 2015]. These results were corroborated by two similar studies [Amin et al 2014;Tepper, 2015].…”

Section: Safety Of Apixabanmentioning

confidence: 64%

Efficacy and safety of the target-specific oral anticoagulants for stroke prevention in atrial fibrillation: the real-life evidence

Russo

Rago

Proietti

et al. 2016

Therapeutic Advances in Drug Safety

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Abstract:The aim of our article is to provide a concise review for clinicians entailing the main studies that evaluated the efficacy and safety of target-specific oral anticoagulants (TSOAs) for thromboembolic stroke prevention in the real-world setting. Atrial fibrillation (AF) is one of the most common supraventricular arrhythmias that requires anticoagulation therapy to prevent stroke and systemic embolism. TSOAs, dabigatran, apixaban and rivaroxaban have become available as an alternative to warfarin anticoagulation in nonvalvular atrial fibrillation (NVAF). Randomized clinical trials showed non-inferior or superior results in efficacy and safety of the TSOAs compared with warfarin for stroke prevention in NVAF patients. For this reason, the 2012 update to the European Society of Cardiology guidelines for the management of AF recommends TSOAs as broadly preferable to vitamin K antagonists (VKAs) in the vast majority of patients with NVAF [Camm et al. 2012]. Although the clinical trial results and the guideline's indications, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. Recently, a large number of studies testing the efficacy and the safety of TSOAs in clinical practice have been published. The aim of our article is to provide a concise review for clinicians, outlining the main studies that evaluated the efficacy and safety of TSOAs for thromboembolic stroke prevention in the real-world setting.

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Real-World Comparison of Inpatient Bleeding Risk, Bleeding-Related Hospitalization Rates and Costs Among Non-Valvular Atrial Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban: Cohorts Comprising New Initiators and/or Switchers From Warfarin

Cited by 9 publications

References 0 publications

Bleeding Complications in Patients Receiving Direct Oral Anticoagulant Therapy in the Post Clinical Trial General Practice

Bleeding Complications in Patients Receiving Direct Oral Anticoagulant Therapy in the Post Clinical Trial General Practice

Safety of direct oral anticoagulants: insights from postmarketing studies

Efficacy and safety of the target-specific oral anticoagulants for stroke prevention in atrial fibrillation: the real-life evidence

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