☆ 4.6 Review

News at XI: moving beyond factor Xa inhibitors

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2023)

Related references

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Article Cardiac & Cardiovascular Systems

Pharmacology and Clinical Development of Factor XI Inhibitors

Antonio Greco et al.

Summary: Therapeutic anticoagulation is used to prevent or treat blood clots, but it can increase the risk of bleeding. Inhibitors of Factor XI (FXI) show promise in reducing the adverse events of anticoagulation. Large-scale phase 3 clinical trials are needed to confirm the role of FXI inhibitors and determine their clinical indications.

CIRCULATION (2023)

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Reversal agents for current and forthcoming direct oral anticoagulants

Nick van Es et al.

Summary: In the past 20 years, there has been a transition from vitamin K antagonists to direct oral anticoagulants (DOACs). DOACs include dabigatran, apixaban, edoxaban, and rivaroxaban. Although DOACs are associated with less serious bleeding, reversal agents may be needed in cases of serious bleeding or urgent surgery/intervention. This paper provides insight into reversing the effects of DOACs, discusses new reversal agents, and outlines a strategic framework for reversing factor XI inhibitors in clinical trials.

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Factor XI inhibitors: cardiovascular perspectives

Raffaele De Caterina et al.

Summary: This paper reviews the potential of drugs targeting factor XI in anticoagulant therapy, along with ongoing clinical trials and future research directions.

EUROPEAN HEART JOURNAL (2023)

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Article Pharmacology & Pharmacy

Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study

Dagmar Kubitza et al.

Summary: The study evaluated the oral activated factor XI (FXIa) inhibitor, BAY 2433334, in healthy volunteers. The results showed that multiple dosing of BAY 2433334 was well tolerated and had a predictable pharmacokinetic/pharmacodynamic profile without clinically relevant CYP3A4 induction or inhibition.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2022)

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Article Medicine, Research & Experimental

First-in-human study of milvexian, an oral, direct, small molecule factor XIa inhibitor

Vidya Perera et al.

Summary: The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of Milvexian in healthy adults, showing that the drug's properties are suitable for further clinical development.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2022)

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Article Hematology

Milvexian, an orally bioavailable, small-molecule, reversible, direct inhibitor of factor XIa: In vitro studies and in vivo evaluation in experimental thrombosis in rabbits

Pancras C. Wong et al.

Summary: Milvexian is an effective antithrombotic agent with limited impact on hemostasis, even when combined with aspirin. The study results suggest that Milvexian has a wide therapeutic window for antithrombotic therapy.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

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Article Medicine, General & Internal

Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Jonathan P. Piccini et al.

Summary: This study compared the incidence of bleeding in patients with atrial fibrillation between Asundexian and apixaban, showing that Asundexian resulted in lower rates of bleeding compared with standard dosing of apixaban.

LANCET (2022)

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Review Cardiac & Cardiovascular Systems

Factor XI Inhibitors for Prevention and Treatment of Venous Thromboembolism: A Review on the Rationale and Update on Current Evidence

Stephan Nopp et al.

Summary: While anticoagulation therapy has made progress, thrombosis remains a leading cause of death worldwide. Direct oral anticoagulants dominate clinical practice, but bleeding risk is still significant. Therefore, research focuses on developing safer anticoagulants, with factor XI (FXI) inhibition as a promising target.

FRONTIERS IN CARDIOVASCULAR MEDICINE (2022)

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Article Hematology

Comparing the efficacy and safety of direct oral anticoagulants versus Vitamin K antagonists in patients with antiphospholipid syndrome: a systematic review and meta-analysis

Xiaoling Wu et al.

Summary: Thromboprophylaxis is crucial in treating APS, and VKAs remain the first-choice treatment for high-risk APS patients, while DOACs are more appropriate for low-risk APS patients. The use of Rivaroxaban is associated with an increased risk of recurrent thrombosis in APS patients.

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Article Cardiac & Cardiovascular Systems

A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

Sunil Rao et al.

Summary: This study investigated the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). The results showed that asundexian effectively inhibited coagulation activity without increasing the risk of bleeding or ischemic events.

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Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo- controlled, phase 2b trial

Ashkan Shoamanesh et al.

Summary: In this phase 2b trial, FXIa inhibition with asundexian did not reduce the occurrence of covert brain infarction or ischemic stroke and did not increase the risk of major or clinically relevant non-major bleeding compared to placebo in patients with acute, non-cardioembolic ischemic stroke.

LANCET (2022)

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Atrial valvular fibrillation: OAC or VKA?

H. Vaillant et al.

EXERCER-LA REVUE FRANCOPHONE DE MEDECINE GENERALE (2022)

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Article Multidisciplinary Sciences

Liver-heart cross-talk mediated by coagulation factor XI protects against heart failure

Yang Cao et al.

Summary: Tissue-tissue communication through endocrine factors is crucial for physiological homeostasis. A study on mice showed that coagulation factor XI (FXI), a protein derived from the liver, protects against diastolic dysfunction, a key trait of heart failure with preserved ejection fraction. FXI was found to activate the BMP-SMAD1/5 pathway in the heart and inhibit genes associated with inflammation and fibrosis, by cleaving and activating extracellular matrix-associated BMP7. This study reveals a protective role of FXI in heart injury that is separate from its role in blood coagulation.

SCIENCE (2022)

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Article Medicine, General & Internal

Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation

S. J. Connolly et al.

Summary: Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy leads to a lower rate of a composite of cardiovascular events or death compared to rivaroxaban therapy, without a higher rate of bleeding.

NEW ENGLAND JOURNAL OF MEDICINE (2022)

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Article Pharmacology & Pharmacy

PK/PD modeling of FXI antisense oligonucleotides to bridge the dose-FXI activity relation from healthy volunteers to end-stage renal disease patients

Stefan Willmann et al.

Summary: A model-informed bridging approach was used to extrapolate dose-exposure-FXI relationship from IONIS-FXIRX to FXI-LICA in patients with ESRD, supporting the selection of doses being investigated. This approach helped predict dose-dependent steady-state FXI activity following repeat once-monthly doses of FXI-LICA in ESRD patients, with doses of 40 mg, 80 mg, and 120 mg covering the target range of clinical interest.

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Polyanions in Coagulation and Thrombosis: Focus on Polyphosphate and Neutrophils Extracellular Traps

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Article Cardiac & Cardiovascular Systems

Real-world safety and efficacy of direct oral anticoagulants in atrial fibrillation: a systematic review and meta-analysis of 605 771 patients

Danilo Menichelli et al.

Summary: Analysis of real-world studies in atrial fibrillation (AF) patients shows significant differences in safety among direct oral anticoagulants (DOACs), with Apixaban potentially being the preferred treatment choice.

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Jeffrey Weitz et al.

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Factor XI Inhibition to Uncouple Thrombosis From Hemostasis JACC Review Topic of the Week

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Summary: Hemostasis and thrombosis are closely linked, with factor XI inhibitors potentially providing a safer alternative to current anticoagulants. Clinical studies are ongoing to determine the efficacy of factor XI inhibitors in attenuating thrombosis without disrupting hemostasis.

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Abelacimab for Prevention of Venous Thromboembolism

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Factor XI deficiency is associated with lower risk for cardiovascular and venous thromboembolism events

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Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis

Harry R. Bueller et al.

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Epidemiologic and clinical data linking factors XI and XII to thrombosis

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