Spotlight on idarucizumab and its potential for the reversal of anticoagulant effects of dabigatran

References

• ThalerJPabingerIAyCAnticoagulant treatment of deep vein thrombosis and pulmonary embolism: the present state of the artFront Cardiovasc Med201523026664901
   PubMedGoogle Scholar
• VerheugtFWGrangerCBOral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needsLancet2015386999030331025777666
   PubMed Web of Science ®Google Scholar
• HuhtakangasJTetriSJuvelaSSaloheimoPBodeMKHillbomMEffect of increased warfarin use on warfarin-related cerebral hemorrhage: a longitudinal population-based studyStroke20114292431243521799168
   PubMed Web of Science ®Google Scholar
• WysowskiDKNourjahPSwartzLBleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory actionArch Intern Med2007167131414141917620536
   PubMed Web of Science ®Google Scholar
• Chai-AdisaksophaCCrowtherMIsayamaTLimWThe impact of bleeding complications in patients receiving target-specific oral anticoagulants: a systematic review and meta-analysisBlood2014124152450245825150296
   PubMed Web of Science ®Google Scholar
• Chai-AdisaksophaCHillisCIsayamaTLimWIorioACrowtherMMortality outcomes in patients receiving direct oral anticoagulants: a systematic review and meta-analysis of randomized controlled trialsJ Thromb Haemost201513112012202026356595
   PubMed Web of Science ®Google Scholar
• Beyer-WestendorfJFörsterKPannachSRates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registryBlood2014124695596224859362
   PubMed Web of Science ®Google Scholar
• Beyer-WestendorfJEbertzFFörsterKEffectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC RegistryThromb Haemost201511361247125725739533
   PubMed Web of Science ®Google Scholar
• BouillonKBertrandMMauraGBlotièrePORicordeauPZureikMRisk of bleeding and arterial thromboembolism in patients with non-valvular atrial fibrillation either maintained on a vitamin K antagonist or switched to a non-vitamin K-antagonist oral anticoagulant: a retrospective, matched-cohort studyLancet Haematol201524e150e15926687957
   PubMed Web of Science ®Google Scholar
• CrowtherMCrowtherMAAntidotes for novel oral anticoagulants: current status and future potentialArterioscler Thromb Vasc Biol20153581736174526088576
   PubMed Web of Science ®Google Scholar
• HauelNNarHPriepkeHRiesUStassenJMWienenWStructure-based design of novel potent nonpeptide thrombin inhibitorsJ Med Chem20024591757176611960487
   PubMed Web of Science ®Google Scholar
• StangierJClemensAPharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitorClin Appl Thromb Hemost200915suppl 19S16S19696042
   PubMed Web of Science ®Google Scholar
• LindahlTLBaghaeiFBlixterIFExpert Group on Coagulation of the External Quality Assurance in Laboratory Medicine in SwedenEffects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assaysThromb Haemost2011105237137821103660
   PubMed Web of Science ®Google Scholar
• Van RynJStangierJHaertterSDabigatran etexilate, a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activityThromb Haemost201010361116112720352166
   PubMed Web of Science ®Google Scholar
• ErikssonBIDahlOERosencherNRE-NOVATE Study GroupDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trialLancet2007370959194995617869635
   PubMed Web of Science ®Google Scholar
• ErikssonBIDahlOERosencherNRE-MODEL Study GroupOral dabigatran etexilate vs subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trialJ Thromb Haemost200752178218517764540
   PubMed Web of Science ®Google Scholar
• RE-MOBILIZE Writing CommitteeGinsbergJSDavidsonBLOral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgeryJ Arthroplasty20092411918534438
   PubMed Web of Science ®Google Scholar
• SchulmanSKearonCKakkarAKRE-COVER Study GroupDabigatran versus warfarin in the treatment of acute venous thromboembolismN Engl J Med2009361242342235219966341
   PubMed Web of Science ®Google Scholar
• ConnollySJEzekowitzMDYusufSRE-LY Steering Committee and InvestigatorsDabigatran versus warfarin in patients with atrial fibrillationN Engl J Med2009361121139115119717844
   PubMed Web of Science ®Google Scholar
• SchieleFvan RynJCanadaKA specific antidote for dabigatran: functional and structural characterizationBlood2013121183554356223476049
   PubMed Web of Science ®Google Scholar
• MillarCMLaneDABlocking direct inhibitor bleedingBlood2013121183543354423640994
   PubMed Web of Science ®Google Scholar
• FlanaganRJJonesALFab antibody fragments: some applications in clinical toxicologyDrug Saf200427141115113315554746
   PubMed Web of Science ®Google Scholar
• GrottkeOvan RynJSpronkHMRossaintRProthrombin complex concentrates and a specific antidote to dabigatran are effective ex-vivo in reversing the effects of dabigatran in an anticoagulation/liver trauma experimental modelCrit Care2014181R2724499559
   PubMed Web of Science ®Google Scholar
• GlundSMoschettiVNorrisSA randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatranThromb Haemost201511394395125789661
   PubMed Web of Science ®Google Scholar
• GlundSStangierJSchmohlMSafety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trialLancet2015386999468069026088268
   PubMed Web of Science ®Google Scholar
• GlundSStangierJSchmohlMIdarucizumab, a specific antidote for dabigatran: immediate, complete and sustained reversal of dabigatran induced anticoagulation in elderly and renally impaired subjectsBlood201412421344 Abstract24914142
   PubMed Web of Science ®Google Scholar
• PollackCVJrReillyPABernsteinRDesign and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatranThromb Haemost2015114119820526020620
   PubMed Web of Science ®Google Scholar
• PollackCVJrReillyPAEikelboomJIdarucizumab for dabigatran reversalN Engl J Med2015373651152026095746
   PubMed Web of Science ®Google Scholar
• ReillyPALehrTHaertterSRE-LY InvestigatorsThe effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY trial (randomized evaluation of long-term anticoagulation therapy)J Am Coll Cardiol201463432132824076487
   PubMed Web of Science ®Google Scholar
• KunduASenPSardarPChatterjeeSKapoorAMcManusDDIntracranial hemorrhage with target specific oral anticoagulants in patients with atrial fibrillation: an updated meta-analysis of randomized controlled trialsInt J Cardiol2016152031000100226630621
   PubMedGoogle Scholar
• MarijonELe HeuzeyJYConnollySCauses of death and influencing factors in patients with atrial fibrillation: a competing-risk analysis from the randomized evaluation of long-term anticoagulant therapy studyCirculation2013128202192220124016454
   PubMed Web of Science ®Google Scholar
• DouketisJDHealeyJSBrueckmannMUrgent surgery or procedures in patients taking dabigatran or warfarin: analysis of perioperative outcomes from the RE-LY trialThromb Res2016139778126916299
   PubMed Web of Science ®Google Scholar
• SeiffgeDJHooffRJNolteCHNOACISP Study GroupRecanalization therapies in acute ischemic stroke patients: impact of prior treatment with novel oral anticoagulants on bleeding complications and outcomeCirculation2015132131261126926232277
   PubMed Web of Science ®Google Scholar
• DouxfilsJDognéJMMullierFComparison of calibrated dilute thrombin time and aPTT tests with LC-MS/MS for the therapeutic monitoring of patients treated with dabigatran etexilateThromb Haemost2013110354354923783171
   PubMed Web of Science ®Google Scholar
• LessireSDouxfilsJBaudarJIs thrombin time useful for the assessment of dabigatran concentrations? An in vitro and ex vivo studyThromb Res2015136369369626251077
   PubMed Web of Science ®Google Scholar
• KaatzSKouidesPAGarciaDAGuidance on the emergent reversal of oral thrombin and factor Xa inhibitorsAm J Hematol201287suppl 1S141S14522473649
   PubMed Web of Science ®Google Scholar
• Lazo-LangnerALangESDouketisJClinical review: clinical management of new oral anticoagulants: a structured review with emphasis on the reversal of bleeding complicationsCrit Care201317323023806169
   PubMed Web of Science ®Google Scholar
• PernodGAlbaladejoPGodierAWorking Group on Perioperative HaemostasisManagement of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP)Arch Cardiovasc Dis20131066–738239323810130
   PubMed Web of Science ®Google Scholar
• SiegalDMCukerAReversal of novel oral anticoagulants in patients with major bleedingJ Thromb Thrombolysis201335339139823389753
   PubMed Web of Science ®Google Scholar
• AlikhanRRaymentRKeelingDThe acute management of haemorrhage, surgery and overdose in patients receiving dabigatranEmerg Med J201431216316823435652
   PubMed Web of Science ®Google Scholar
• HeidbuchelHVerhammePAlingsMUpdated European heart rhythm association practical guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillationEuropace201517101467150726324838
   PubMed Web of Science ®Google Scholar
• EerenbergESKamphuisenPWSijpkensMKMeijersJCBullerHRLeviMReversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjectsCirculation2011124141573157921900088
   PubMed Web of Science ®Google Scholar
• MarluRHodajEParisAAlbaladejoPCracowskiJLPernodGEffect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteersThromb Haemost2012108221722422627883
   PubMed Web of Science ®Google Scholar
• HonickelMMaronBvan RynJTherapy with activated prothrombin complex concentrate is effective in reducing dabigatran-associated blood loss in a porcine polytrauma modelThromb Haemost2016115227128426333775
   PubMed Web of Science ®Google Scholar
• ZhouWSchwartingSIllanesSHemostatic therapy in experimental intracerebral hemorrhage associated with the direct thrombin inhibitor dabigatranStroke201142123594359921998060
   PubMed Web of Science ®Google Scholar
• SarichTCSeltzerJHBerkowitzSDNovel oral anticoagulants and reversal agents: considerations for clinical developmentAm Heart J2015169675175726027611
   PubMed Web of Science ®Google Scholar
• HartRGDienerHCYangSIntracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trialStroke20124361511151722492518
   PubMed Web of Science ®Google Scholar
• MayerSABrunNCBegtrupKEfficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhageN Engl J Med20083582127213718480205
   PubMed Web of Science ®Google Scholar
• TazarourteKRiouBTremeyBEPAHK Study GroupGuideline-concordant administration of prothrombin complex concentrate and vitamin K is associated with decreased mortality in patients with severe bleeding under vitamin K antagonist treatment (EPAHK study)Crit Care2014182R8124762166
   PubMed Web of Science ®Google Scholar
• KulstadEBSikkaRSweisRTKelleyKMRzechulaKHED overcrowding is associated with an increased frequency of medication errorsAm J Emerg Med201028330430920223387
   PubMed Web of Science ®Google Scholar