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Total 18 results found since Jan 2013.
FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias
CONCLUSIONS: This meta-analysis showed that the evidence is uncertain to inform the decision to either interrupt or continue anticoagulation therapy around CA procedure in adults with arrhythmia on outcomes of thromboembolic events, major and minor bleeding, all-cause mortality, asymptomatic thromboembolic events, and a composite endpoint of thromboembolic events (stroke, systemic embolism, major bleeding, and all-cause mortality). Most studies in the review adopted a minimal interruption strategy which has the advantage of reducing the risk of bleeding while maintaining a lower level of anticoagulation to prevent periproc...
Source: Cochrane Database of Systematic Reviews - October 21, 2021 Category: General Medicine Authors: Ghada A Bawazeer Hadeel A Alkofide Aya A Alsharafi Nada O Babakr Arwa M Altorkistani Tarek S Kashour Michael Miligkos Khalid M AlFaleh Lubna A Al-Ansary Source Type: research
Comparison of short-term clinical outcomes between low-dose prasugrel and clopidogrel as part of triple antithrombotic therapy in patients requiring oral anticoagulant therapy and percutaneous coronary intervention
ConclusionsCombination of low-dose prasugrel and DOAC was associated with lower incidence of MI, ischemic stroke, and blood transfusion. Low-dose prasugrel may be feasible as part of triple therapy in patients undergoing PCI.
Source: PLoS One - July 28, 2022 Category: Biomedical Science Authors: Hideki Kitahara Source Type: research
Risk Profile and 1-Year Outcome of Newly Diagnosed Atrial Fibrillation in Japan - Insights From GARFIELD-AF.
CONCLUSIONS: GARFIELD-AF continues to provide important information on the homogeneity and heterogeneity of baseline characteristics and treatment patterns in patients with newly diagnosed NVAF. This diversity reflects the differences in outcomes in Japan compared with the rest of the world.
PMID: 30518731 [PubMed - as supplied by publisher]
Source: Circulation Journal - December 4, 2018 Category: Cardiology Authors: Koretsune Y, Etoh T, Katsuda Y, Suetsugu T, Kumeda K, Sakuma I, Eshima K, Shibuya M, Ando SI, Yokota N, Goto S, Pieper KS, Allu J, Kakkar AK, GARFIELD-AF Investigators Tags: Circ J Source Type: research
Clinical and economic impact of rivaroxaban on the burden of atrial fibrillation: the case study of Japan.
CONCLUSIONS: Introducing rivaroxaban may decrease the burden of NVAF in Japanese society. From a clinical perspective, the reduction in IS and embolic events outweighs the increased risk of anticoagulant-related bleeding; from an economic perspective, reduced event costs offset drug and physician visit costs, resulting in cost savings.
PMID: 27112188 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - April 27, 2016 Category: Health Management Tags: J Med Econ Source Type: research
EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial
Publication date: November 2018Source: American Heart Journal, Volume 205Author(s): Nicolas M. Van Mieghem, Martin Unverdorben, Marco Valgimigli, Roxana Mehran, Eric Boersma, Usman Baber, Christian Hengstenberg, Minggao Shi, Cathy Chen, Shigeru Saito, Roland Veltkamp, Pascal Vranckx, George D. DangasTranscatheter aortic valve implantation, also called transcatheter aortic valve replacement (TAVR), is the treatment of choice for patients with severe aortic stenosis and intermediate to high operative risk. A significant portion of TAVR patients have atrial fibrillation (AF) requiring chronic oral anticoagulation. In moderate...
Source: American Heart Journal - August 30, 2018 Category: Cardiology Source Type: research
Current Status, Time Trends and Outcomes of Combination Therapy With Oral Anticoagulant and Antiplatelet Drug in Patients With Atrial Fibrillation - The Fushimi AF Registry.
CONCLUSIONS: In Japanese AF patients receiving OAC, the prevalence of combination therapy decreased, with the proportion of NOAC use increasing in 2011-2017. Many patients, however, received off-label NOAC under-dosing, especially in the combination therapy group. Patients with combination therapy had higher incidences of major bleeding as well as stroke/systemic embolism, compared with OAC monotherapy.
PMID: 30381701 [PubMed - as supplied by publisher]
Source: Circulation Journal - October 31, 2018 Category: Cardiology Authors: Masunaga N, Abe M, Ogawa H, Aono Y, Ikeda S, Doi K, An Y, Ishii M, Iguchi M, Esato M, Tsuji H, Wada H, Hasegawa K, Lip GYH, Akao M, Fushimi AF Registry Investigators Tags: Circ J Source Type: research
Contemporary trend of reduced-dose non-vitamin K anticoagulants in Japanese patients with atrial fibrillation: A cross-sectional analysis of a multicenter outpatient registry.
CONCLUSIONS: Nearly half of the NOAC dose reductions in our registry were deemed "non-standardized," which were seen mostly in patients at significant risk for ischemic stroke. The physician's apprehension regarding excessive bleeding under NOAC use should be appropriately balanced with concern for an increased risk of embolic events.
PMID: 30487057 [PubMed - in process]
Source: Journal of Cardiology - December 1, 2018 Category: Cardiology Authors: Ono T, Ikemura N, Kimura T, Ueda I, Tanaka H, Tokuda H, Yajima N, Matsumura K, Suzuki M, Fukuda K, Kohsaka S, Takatsuki S Tags: J Cardiol Source Type: research
Edoxaban vs. Vitamin K Antagonist for Atrial Fibrillation After Transcatheter Aortic Valve Replacement in Japanese Patients - A Subanalysis of the ENVISAGE-TAVI AF Trial
CONCLUSIONS: In Japanese patients with AF after successful TAVR, edoxaban and VKA treatment have similar safety and efficacy profiles.PMID:35965066 | DOI:10.1253/circj.CJ-22-0093
Source: Circulation Journal - August 14, 2022 Category: Cardiology Authors: Yusuke Watanabe Kentaro Hayashida Masanori Yamamoto Futoshi Yamanaka Kazumasa Yamasaki Toru Naganuma Yohei Ohno Masahiro Yamawaki Nobuyuki Morioka Kazuki Mizutani Norio Tada Hiroshi Ueno Hidetaka Nishina Masaki Izumo Yoshifumi Nakajima Kenji Ando Kensuke Source Type: research
Effects of a Pharmacist-Led Educational Interventional Program on Electronic Monitoring-Assessed Adherence to Direct Oral Anticoagulants: A Randomized, Controlled Trial in Patients with Nonvalvular Atrial Fibrillation
In this study, the selection of DOACs was not randomized, and the lack of assessment of the association between adherence to DOACs and clinical outcomes was a limitation. Japan Registry of Clinical Trials (jRCT) indentifier: jRCTs031180142. (Clin Ther. 2022;44:XXX-XXX) © 2022 Elsevier Inc.PMID:36244853 | DOI:10.1016/j.clinthera.2022.09.011
Source: Clinical Therapeutics - October 16, 2022 Category: Drugs & Pharmacology Authors: Tsuyoshi Shiga Toshimi Kimura Noritoshi Fukushima Yuji Yoshiyama Kazunori Iwade Fumiaki Mori Yoichi Ajiro Shoji Haruta Yuichiro Yamada Emi Sawada Nobuhisa Hagiwara SMAAP-AF Investigators Source Type: research
