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Total 236 results found since Jan 2013.

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

Second death linked to potential antibody treatment for Alzheimer ’s disease
A 65-year-old woman who was receiving a promising experimental treatment to slow the cognitive decline caused by her early Alzheimer’s disease recently died from a massive brain hemorrhage that some researchers link to the drug. The clinical trial death, described in an unpublished case report Science has obtained, is the second thought to be associated with the antibody called lecanemab. The newly disclosed fatality intensifies questions about its safety and how widely lecanemab should be prescribed if ultimately approved by regulators. The woman, who received infusions of the antibody as part of the trial, s...
Source: ScienceNOW - November 28, 2022 Category: Science Source Type: news

Effectiveness and Safety of Rivaroxaban by General Practitioners 　- A Multicenter, Prospective Study in Japanese Patients With Non-Valvular Atrial Fibrillation (GENERAL)
CONCLUSIONS: The low incidence of adverse events, including stroke/SE and bleeding, in patients prescribed rivaroxaban by general practitioners supports its use as a safe and efficacious treatment in the standard clinical care of high-risk patient populations.PMID:33814525 | DOI:10.1253/circj.CJ-20-1244
Source: Circulation Journal - April 5, 2021 Category: Cardiology Authors: Kengo Kusano Nobuyoshi Sugishita Masaharu Akao Hikari Tsuji Kunihiko Matsui Shinya Hiramitsu Yutaka Hatori Hironori Odakura Hiroyuki Kamada Koji Miyamoto Hisao Ogawa Source Type: research

Clinical characteristics and outcomes of Japanese atrial fibrillation patients with poor medication adherence: A sub-analysis of the GENERAL study
CONCLUSIONS: Poor anticoagulant adherence, as measured by PDC <80 %, was associated with higher incidence of stroke or systemic embolism and major bleeding in the GENERAL study.PMID:35985869 | DOI:10.1016/j.jjcc.2022.07.022
Source: Journal of Cardiology - August 19, 2022 Category: Cardiology Authors: Masaharu Akao Hikari Tsuji Kengo Kusano Kunihiko Matsui Shinya Hiramitsu Yutaka Hatori Hironori Odakura Hisao Ogawa Source Type: research

Edoxaban for the Management of Elderly Japanese Patients with Atrial Fibrillation Ineligible for Standard Oral Anticoagulant Therapies: Rationale and Design of the ELDERCARE-AF Study
Publication date: Available online 24 August 2017 Source:American Heart Journal Author(s): Ken Okumura, Gregory Y.H. Lip, Masaharu Akao, Kimihiko Tanizawa, Masayuki Fukuzawa, Kenji Abe, Masahiro Akishita, Takeshi Yamashita Edoxaban—a nonvitamin K antagonist oral anticoagulant (NOAC)— 60-mg and 30-mg once-daily dose regimens are noninferior vs well-managed warfarin for the prevention of stroke or systemic embolic events (SEE) with less major bleeding in patients with nonvalvular atrial fibrillation (NVAF). There are no published data from phase 3 clinical trials specifically evaluating the use of NOACs in elderly NVAF ...
Source: American Heart Journal - August 24, 2017 Category: Cardiology Source Type: research

Oral anticoagulant use and clinical outcomes in elderly Japanese patients: findings from the SAKURA AF Registry
AbstractDirect-acting oral anticoagulants (DOACs) are widely used in aged Japanese patients with atrial fibrillation (AF), but outcome data for such patients are limited. We compared outcomes between 1895 (58.5%) patients aged<  75 years (non-elderly), 1078 (33.3%) 75–84 years (elderly) and 264 (8.2%) ≥ 85 years (very elderly) enrolled in a prospective multicenter registry. Kaplan–Meier analysis (median follow-up: 39.3 months) revealed a significantly high incidence of stroke/systemic embolism (SE) among the very elderly relative to that among the non-elderly or elderly (3.2 vs. 1.2 and 1.5 events per 100 ...
Source: Heart and Vessels - June 9, 2019 Category: Cardiology Source Type: research

Real-world outcomes of rivaroxaban treatment in elderly Japanese patients with nonvalvular atrial fibrillation
In conclusion, safety and effectiveness event rates were higher in patients aged ≥ 75 years compared w ith those aged <  75 years, yet, no distinct differences were observed among the 3 elderly sub-populations.
Source: Heart and Vessels - September 5, 2019 Category: Cardiology Source Type: research

Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation: a propensity-matched analysis from Japanese administrative claims data.
CONCLUSIONS: Our observational data from clinical practice broadly confirm the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAF patients. PMID: 29772946 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - May 19, 2018 Category: Research Tags: Curr Med Res Opin Source Type: research

Oral Anticoagulants in Japanese Patients with Atrial Fibrillation and Active Cancer.
Conclusion The rates of stroke or systemic embolism and major bleeding events were not negligible among Japanese cancer patients with AF receiving OACs. Further investigations on the optimal management of Japanese patients with AF and cancer are needed. PMID: 30799369 [PubMed - as supplied by publisher]
Source: Internal Medicine - February 26, 2019 Category: Internal Medicine Tags: Intern Med Source Type: research

Impact of creatinine clearance on clinical outcomes in elderly atrial fibrillation patients receiving apixaban: J-ELD AF registry sub-analysis
ConclusionsThe incidence of events in each CCr value group was comparable for stroke or systemic embolism and bleeding requiring hospitalization, and significantly higher for total deaths and cardiovascular deaths only in the CCr 15–29 mL/min group, in Japanese non-valvular AF patients aged ≥75 years.
Source: American Heart Journal - February 9, 2020 Category: Cardiology Source Type: research

Association of Low Body Weight with Clinical Outcomes in Elderly Atrial Fibrillation Patients Receiving Apixaban —J-ELD AF Registry Subanalysis
ConclusionsThe incidence of events in each body weight group was comparable for stroke or systemic embolism and bleeding requiring hospitalization, and body weight<50 kg might not be an independent risk for death in Japanese non-valvular AF patients aged ≥ 75 years taking on-label doses of apixaban.
Source: Cardiovascular Drugs and Therapy - April 8, 2021 Category: Cardiology Source Type: research

Effectiveness and safety of transcatheter left atrial appendage closure
J Cardiol. 2021 Sep 23:S0914-5087(21)00234-3. doi: 10.1016/j.jjcc.2021.08.031. Online ahead of print.ABSTRACTAtrial fibrillation (AF) is responsible for cardiogenic stroke. Since left atrial appendage (LAA) is a cause of most of cardiac thrombus, LAA closure is an emerging novel stroke prevention procedure for patients with AF alternative to anticoagulation. WATCHMAN LAA Closure device (Boston Scientific, Marlborough, MA, USA) is the only approved device in the USA and Japan. The device is indicated in high bleeding risk and high stroke risk non-valvular AF patients. Cardiac tamponade, stroke, and device embolization are t...
Source: Journal of Cardiology - September 27, 2021 Category: Cardiology Authors: Yoshifumi Nakajima Source Type: research