Rivaroxaban

Data presented at the American Heart Association Scientific Sessions show a 67% reduction in bleeding for patients on antiplatelet therapy taking abelacimab as compared to rivaroxaban AZALEA-TIMI 71 is the largest head-to-head study of a factor XI inhibitor against a direct-oral anticoagulant Nov. 16, 2024 -- Anthos Therapeutics, Inc., a transformative, clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiovascular metabolic diseases, presented new data today at the American Heart Association (AHA) Scientific Sessions from its landmark AZALEA-TIMI 71 study that demonstrated the novel factor XI inhibitor abelacimab led to consistent and substantial reductions in bleeding for patients on or off antiplatelet (APT) therapy, as compared to rivaroxaban. "Given the elevated bleeding risks associated with traditional anticoagulants, particularly when combined with antiplatelet agents, abelacimab may offer a safer alternative for patients with atrial fibrillation,” said Christian T. Ruff, MD, MPH, senior investigator of TIMI Group and director General Cardiology, Cardiovascular Division, Brigham and Women's Hospital. “These data suggest that abelacimab may potentially be an attractive option for those patients who could benefit from anticoagulation and antiplatelet therapy.” The data demonstrate a 67% reduction in bleeding for patients on APT taking abelacimab 150 mg compared to patients taking rivaroxaban (a 10.6% incidence rate for rivaroxaban to a 3.5% incidence rate for abelacimab 150 mg).1 As expected, the absolute rate of bleeding observed was higher when rivaroxaban was combined with APT vs. rivaroxaban alone (10.6% vs. 7.7%).1 However, the rate of bleeding in patients treated with abelacimab 150 mg was similar, regardless of APT use (3.5% abelacimab with APT vs 3.1% abelacimab alone).1 The absolute risk difference between abelacimab 150 mg and rivaroxaban was also greater in patients on APT compared to those not on APT (7.1% vs 4.6%).1 "Many patients taking antiplatelet therapy are simply not prescribed anticoagulants because of the fear of bleeding, leaving them without protection from the risk of stroke,” said Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics. “The absence of a meaningful increase in bleeding when abelacimab is added to APT as demonstrated in this trial is remarkable and provides further evidence that, if approved, factor XI inhibitors are likely to transform how physicians will approach treating patients who need to be anticoagulated to reduce their risk of stroke.” Patient Population: Out of the 1,287 patients enrolled in the study, 318 (25%) were already taking antiplatelet therapy (APT), which is medication to prevent blood clots. APT included either aspirin alone (16%), another type of drug called P2Y12 (7%), or both (DAPT – dual antiplatelet therapy) (2%). Patient Demographics: Patients on APT had a higher rate of coronary artery disease (70% vs. 42%), previous heart attacks (36% vs. 16%), and peripheral artery disease (15% vs. 11%). Founded by Blackstone Life Sciences (BXLS) in 2019, Anthos Therapeutics is a transformative, clinical-stage biopharmaceutical company with the exclusive global rights from Novartis Pharma AG to develop, manufacture and commercialize abelacimab. For more information, visit the Company’s website and follow on Twitter and LinkedIn. Launched in February, 2021, the AZALEA-TIMI 71 study enrolled 1,287 patients across 95 global study sites, including the U.S. and Canada, Europe and Asia. With a median follow-up of 2.1 years, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a factor XI inhibitor compared to a standard-of-care anticoagulant. Abelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to factor XI to block its activation and prevent the generation of the activated form (factor XIa). This mimics natural factor XI deficiency, which is associated with protection from thromboembolic disease.2 As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low.3 There is no need to adjust the dose based on age or renal/hepatic status.3 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.3 Abelacimab is the only factor XI inhibitor being studied for both conditions. If approved, abelacimab is planned to be dosed subcutaneously (SC) monthly by patients with atrial fibrillation using an autoinjector to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited factor XI by 99%.1 In a PK/PD study, abelacimab administered by IV provided profound suppression of factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.4 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.5 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. 1 TIMI Study Group website, AZALEA 71 2 Goodman SG et al. Crit Pathways in Cardiol 2024;23: 47–57 3 Hsu et al. J Am Coll Cardiol. Aug. 2021 4 Yi BA et al. J Thromb Haemost. Oct. 2021 5 Verhamme P et al. New Engl J Med July 2021 The content above comes from the network. if any infringement, please contact us to modify.

MONDAY, Nov. 18, 2024 -- People on blood thinners have a doubled risk of dangerous internal bleeding if they also take a non-steroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, a new study warns. People typically are prescribed blood thinners to treat or prevent strokes , heart attacks, or blood clots in the legs or lungs, researchers said. NSAIDs also are known to thin the blood, and the new study shows that they can increase risk of uncontrolled bleeding in the gut, brain, lungs and bladder if taken alongside a blood thinner. “We found that for patients taking blood thinners for blood clots in the legs or lungs, using NSAIDs doubled the risk of bleeding compared with not using NSAIDs,” said researcher Soren Riis Peterson , a medical student with Aarhus University Hospital in Denmark. “The increased bleeding risk associated with NSAID use was not limited to the digestive tract but also seemed to affect other organ systems.” For the study, researchers analyzed data on nearly 52,000 Danish patients prescribed a blood thinner to treat a blood clot between 2012 and 2022. In Denmark, the NSAIDs diclofenac and naproxen can only be obtained through a prescription. This allowed researchers to track the health of patients who had been prescribed both a blood thinner and an NSAID. Overall, the risk of a bleed was two times higher when people took a blood thinner and an NSAID, compared to just taking a blood thinner, researchers found. The specific risk was four times higher for naproxen, three times higher for diclofenac and nearly twice as high for ibuprofen. Specific bleed risks included: Using NSAIDs with a blood thinner also tripled a person’s risk of anemia, researchers found. The pattern of risk remained similar across a wide variety of blood thinners, including rivaroxaban , apixaban , dabigatran , edoxaban and warfarin , results show. The new study was published Nov. 17 in the European Heart Journal . “For people taking blood thinners for blood clots in their legs or lungs, our research highlights the importance of being cautious when considering NSAIDs for pain or inflammation,” Petersen concluded in a journal news release. “We recommend that patients consult their doctor before taking NSAIDs along with a blood thinner.” In an accompanying editorial, Dr. Robert Storey , a professor of clinical cardiology with the University of Sheffield in the U.K., noted that NSAIDs are widely used, making up about 8% of prescriptions worldwide and often available over-the-counter. “It seems clear that avoiding NSAIDs in combination with [blood thinners] is the safest strategy to avoid excess bleeding risk,” Storey wrote. “However, if this is not possible, what mitigation can be put in place? NSAID prescription should obviously be at the lowest dose and for the shortest time possible, but choice of agent and route may also be important.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.