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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

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

Mechanical thrombectomy for a 12-year-old boy with acute ischemic stroke: A case report
Conclusions: Mechanical thrombectomy can be performed safely for children with AIS, but needs a further research with large samples.
Source: Medicine - July 24, 2020 Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research

Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit using...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to Tweet: Jan...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Source Type: news

The association of clopidogrel and 2-oxo-clopidogrel plasma levels and the 40  months clinical outcome after primary PCI
Conclusion Clopidogrel dose-adjusted plasma concentration in STEMI patients, as well as multivessel coronary artery disease, showed significance in predicting an unfavorable composite clinical outcome after 40-month follow-up.
Source: International Journal of Clinical Pharmacy - October 26, 2018 Category: Drugs & Pharmacology Source Type: research

Management of antiplatelet therapy in patients undergoing elective invasive procedures. Proposals from the French Working Group on perioperative haemostasis (GIHP) and the French Study Group on thrombosis and haemostasis (GFHT). In collaboration with the French Society for Anaesthesia and Intensive Care Medicine (SFAR)
Publication date: Available online 5 January 2018Source: Anaesthesia Critical Care & Pain MedicineAuthor(s): Anne Godier, Pierre Fontana, Serge Motte, Annick Steib, Fanny Bonhomme, Sylvie Schlumberger, Thomas Lecompte, Nadia Rosencher, Sophie Susen, André Vincentelli, Yves Gruel, Pierre Albaladejo, Jean-Philippe Collet, P. Albaladejo, S. Belisle, N. Blais, F. Bonhomme, A. Borel-Derlon, J.Y. Borg, J.-L. BossonAbstractThe French Working Group on Perioperative Haemostasis (GIHP) and the French Study Group on Haemostasis and Thrombosis (GFHT) in collaboration with the French Society for Anaesthesia and Intensive Care Medicine...
Source: Anaesthesia, Critical Care and Pain Medicine - July 10, 2018 Category: Anesthesiology Source Type: research

Management Of Antiplatelet Therapy In Patients Undergoing Elective Invasive Procedures Proposals From The French Working Group On Perioperative Hemostasis (Gihp) And The French Study Group On Thrombosis And Hemostasis (Gfht) In Collaboration With The French Society For Anesthesia And Intensive Care (Sfar)
Publication date: Available online 5 January 2018 Source:Anaesthesia Critical Care & Pain Medicine Author(s): Anne Godier, Pierre Fontana, Serge Motte, Annick Steib, Fanny Bonhomme, Sylvie Schlumberger, Thomas Lecompte, Nadia Rosencher, Sophie Susen, André Vincentelli, Yves Gruel, Pierre Albaladejo, Jean-Philippe Collet The French Working Group on Perioperative Hemostasis (GIHP) and the French Study Group on Hemostasis and Thrombosis (GFHT) in collaboration with the French Society for Anesthesia and Intensive Care (SFAR) drafted up-to-date proposals for the management of antiplatelet therapy in patients undergoin...
Source: Anaesthesia, Critical Care and Pain Medicine - January 6, 2018 Category: Anesthesiology Source Type: research

Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.
CONCLUSIONS: Nearly 5% of patients enrolled in EUCLID had CLI at baseline. Milder forms of CLI dominated, a result of the trial design. Patients with CLI had a significantly higher rate of cardiovascular mortality and morbidity versus those without CLI. Further efforts are required to reduce the risk of cardiovascular events in PAD, especially in patients with CLI. CLINICALTRIALS.GOV: NCT01732822. PMID: 29273390 [PubMed - as supplied by publisher]
Source: PubMed: Eur J Vasc Endovasc ... - December 19, 2017 Category: Surgery Authors: Norgren L, Patel MR, Hiatt WR, Wojdyla DM, Fowkes FGR, Baumgartner I, Mahaffey KW, Berger JS, Jones WS, Katona BG, Held P, Blomster JI, Rockhold FW, Björck M, EUCLID Steering Committee and Investigators Tags: Eur J Vasc Endovasc Surg Source Type: research

11-dehydro thromboxane B2 levels after percutaneous transluminal angioplasty in patients with peripheral arterial occlusive disease during a one year follow-up period.
In this study, 175 patients diagnosed with peripheral arterial occlusive disease (PAOD) and demonstrating short-distance claudication or ischemic rest pain, requiring PTA in either the iliac, femoral, or popliteal arteries, were enrolled. The excretion of 11-dehydro thromboxane B2 (TXB2) was measured in urine samples by high-performance liquid chromatography-mass spectrometry and recalculated based on the creatinine concentration. The urine samples were collected the morning prior to PTA, immediately following PTA and the day after PTA. All of the study subjects were then observed for a period of 12 months. Urine samples w...
Source: J Physiol Pharmacol - May 31, 2016 Category: Drugs & Pharmacology Authors: Maga P, Sanak M, Jawien J, Rewerska B, Maga M, Wachsmann A, Koziej M, Gregorczyk-Maga I, Nizankowski R Tags: J Physiol Pharmacol Source Type: research

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