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Total 30 results found since Jan 2013.
New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO ® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)
TITUSVILLE, NJ, March 5, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of ...
Source: Johnson and Johnson - March 5, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
New Data From Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) with XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD)
RARITAN, N.J., May 23, 2022 – Findings from the XARELTO® (rivaroxaban) Phase 3 COMPASS Long-Term Open Label Extension (LTOLE) study and the XARELTO® in Combination with Acetylsalicylic Acid (XATOA) registry have been published in the European Society of Cardiology’s (ESC) European Heart Journal, Cardiovascular Pharmacotherapy. Additionally, the XATOA registry was presented at the American Congress of Cardiology’s 71st Annual Scientific Session (ACC.22). These studies provide further evidence supporting the role of dual pathway inhibition (DPI) with the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg...
Source: Johnson and Johnson - May 23, 2022 Category: Pharmaceuticals Source Type: news
Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement. A meta-analysis of randomized controlled trials
ConclusionsIn patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation.Graphic abstractForest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left...
Source: Clinical Research in Cardiology - January 1, 2022 Category: Cardiology Source Type: research
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 to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. F...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 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
Late-Breaking Data at ACC.21 Show XARELTO ® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization
RARITAN, N.J., May 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients with PAD ...
Source: Johnson and Johnson - May 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Aspirin Alone Versus Dual Antiplatelet Therapy after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis
ConclusionsOur systematic review and meta-analysis suggested that aspirin alone could decrease the risk of bleeding and was not associated with higher risk of mortality, stroke or myocardial infarction compared with DAPT.
Source: Cardiovascular Drugs and Therapy - February 11, 2021 Category: Cardiology Source Type: research
Antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement. A meta-analysis of randomized controlled trials
ConclusionsIn patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation.Graphic abstractForest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left...
Source: Clinical Research in Cardiology - December 23, 2020 Category: Cardiology Source Type: research
New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need for data in ...
Source: Johnson and Johnson - November 9, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Sinus of Valsalva Thrombosis Detected on Computed Tomography after Transcatheter Aortic Valve Replacement.
CONCLUSIONS: Cardiac CT after TAVR can detect sinus of Valsalva thrombosis, and attention should be paid to this potential source of subsequent systemic embolization.
PMID: 32281322 [PubMed - as supplied by publisher]
Source: Korean Circulation Journal - April 14, 2020 Category: Cardiology Tags: Korean Circ J Source Type: research
