Original Article from The New England Journal of Medicine — Oral Apixaban for the Treatment of Acute Venous Thromboembolism. Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary. Original Article from The New England Journal of Medicine — Apixaban in Patients with Atrial Fibrillation.
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This drug will be produced using the generation 1 manufacturing process. N Engl J Med Dec 4 Venous thromboembolism occurred less frequently with the direct oral anticoagulant apixaban than with placebo. Lancet Oncol Nov 1. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. Comment in N Engl J Med.
Blood Dec 3. N Engl J Med. Blood Dec 3 Ravulizumab was noninferior to eculizumab in both previously treated and treatment-naive patients. At 23 years of follow-up, life expectancy was nearly 3 years longer with prostatectomy than with watchful waiting. These trials were designed to evaluate the safety and efficacy of andexanet alfa in reversing the anticoagulant activity of rivaroxaban and apixaban in healthy volunteers. Older patients with previously untreated disease had better outcomes with ibrutinib than with chemo-immunotherapy.
The post-marketing requirement is a trial in which patients will be randomized to receive either andexanet alfa or usual care.
N Engl J Med Dec 1. How Effective Are Guidelines?
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N Engl J Med Dec Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. Gradishar, MD A perspective on the most important research in the field from the apixqban year.
National Comprehensive Cancer Network guidelines for multigene panel testing miss nearly half of patients with actionable variants.
DOACs appear to be as effective as LMWH and are more acceptable to patients, but they pose similar risks for bleeding and should be used cautiously in those with gastrointestinal malignancies, apiaban impairment, or thrombocytopenia. N Engl J Med Dec 1 Older patients with previously untreated disease had better outcomes with ibrutinib than with chemo-immunotherapy.
FDA approves antidote for factor Xa inhibitors |
Apixaban or placebo was given within 24 hours of starting chemotherapy and continued for nfjm months. The rate of the primary outcome was 1. Comment Patients with active malignancies are at risk for VTE but do not always receive prophylactic anticoagulants because of concerns about bleeding, need for injections, and cost.
N Engl J Apixbaan Dec 13 At 23 years of follow-up, life expectancy was nearly 3 years longer with prostatectomy than with watchful waiting. Expert Opin Investig Drugs. This study is scheduled to start inwith results expected to be available in For additional information on andexanet alfa, visit https: Apixaban to prevent venous thromboembolism in patients with cancer.
Venous thromboembolism occurred less frequently with the direct oral anticoagulant apixaban than with placebo. N Engl J Med Dec 4. Once bound, the factor Xa inhibitors are unable to bind to and inhibit native factor Xa, thus potentially allowing for the restoration of normal hemostatic processes.
Blood Dec 3, Kulasekararaj AG et al.
Thromboprophylaxis with Apixaban for Cancer Patients
N Engl J Med Dec 1 Forty percent of patients with relapsed or refractory disease achieved complete remission. J Clin Oncol Dec 7. Portola Pharmaceuticals first submitted the biologics license application BLA for andexanet alfa in December A broader commercial launch of andexanet alfa is anticipated in earlydependent upon FDA approval of the generation 2 manufacturing process.
Andexanet alfa is a modified human factor Xa molecule that acts as a decoy to target and sequester both oral and injectable factor Xa inhibitors in the blood.
In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. The rate of major bleeding was 2. Continued FDA approval of andexanet alfa may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients taking rivaroxaban or apixaban who require reversal of anticoagulation.
J Clin Oncol Dec 7 National Comprehensive Cancer Network guidelines for multigene panel testing miss nearly half of patients with actionable variants. The median duration of follow-up was 1. Whether direct oral anticoagulants DOACs would be safe and effective for this indication is unclear. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.
Gradishar, MD Highlights of the latest research. Results from both studies were published in NEJM in Andexanet alfa is approved for use in patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
About andexanet alfa Andexanet alfa is a modified human factor Xa molecule that acts as a decoy to target and sequester both oral and injectable factor Xa inhibitors in the blood. In Augustthe FDA issued a complete response letter explaining why the agency could not approve andexanet alfa for this indication.
FDA approves antidote for factor Xa inhibitors
Forty percent of patients with relapsed or refractory disease apixabah complete remission. No between-group differences were seen in the rates of adverse events and deaths. N Engl J Med Dec 4; [e-pub].