Dabigatran antithrombotics

Pradax - Pradaxa

Acute coronary syndrome

All ACS (including AMI):  1 trials  - REDEEM

dabigatran vs placebo

No demonstrated result

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All type of patients:  1 trials  - REDEEM

dabigatran vs placebo

No demonstrated result

Atrial fibrillation

All type of patients:  4 trials  - PETRO (150mg) - RE-LY (150mg) - RE-LY (110mg) - phase 2 dabigatran

dabigatran vs warfarin standard dose

No demonstrated result

dabigatran 110mg vs warfarin standard dose

No demonstrated result

suggested Lifethreatening major bleeding by 32% (not demonstrated)

suggested Major bleeding by 20% (not demonstrated)

suggested Haemmorhagic stroke by 69% (not demonstrated)

dabigatran 150mg vs warfarin standard dose

No demonstrated result

Gastrointestinal major bleeding by 50% (harmful effect)

suggested thrombo-embolic event (cerebral or systemic) by 34% (not demonstrated)

suggested ischemic stroke by 24% (not demonstrated)

suggested Haemmorhagic stroke by 74% (not demonstrated)

suggested stroke (fatal and non fatal) by 36% (not demonstrated)

suggested Fatal stroke by 33% (not demonstrated)

suggested Non fatal stroke by 37% (not demonstrated)

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Primary prevention of thromboembolic events:  4 trials  - PETRO (150mg) - RE-LY (150mg) - RE-LY (110mg) - phase 2 dabigatran

dabigatran vs warfarin standard dose

No demonstrated result

dabigatran 110mg vs warfarin standard dose

No demonstrated result

suggested Lifethreatening major bleeding by 32% (not demonstrated)

suggested Major bleeding by 20% (not demonstrated)

suggested Haemmorhagic stroke by 69% (not demonstrated)

dabigatran 150mg vs warfarin standard dose

No demonstrated result

Gastrointestinal major bleeding by 50% (harmful effect)

suggested thrombo-embolic event (cerebral or systemic) by 34% (not demonstrated)

suggested ischemic stroke by 24% (not demonstrated)

suggested Haemmorhagic stroke by 74% (not demonstrated)

suggested stroke (fatal and non fatal) by 36% (not demonstrated)

suggested Fatal stroke by 33% (not demonstrated)

suggested Non fatal stroke by 37% (not demonstrated)

Secondary prevention of thromboembolic events:  2 trials  - RE-LY 150mg (2nd prevention subgroup) - RE-LY 110mg (2nd prevention subgroup)

dabigatran 100mg vs warfarin

No demonstrated result

suggested intracranial hemorrhage by 80% (not demonstrated)

suggested Haemmorhagic stroke by 89% (not demonstrated)

dabigatran 150mg vs warfarin

No demonstrated result

suggested intracranial hemorrhage by 59% (not demonstrated)

suggested Haemmorhagic stroke by 73% (not demonstrated)

Post acute coronary syndromes

All type of patients:  1 trials  - REDEEM

dabigatran vs placebo

No demonstrated result

Post myocardial infarction

All type of patients:  1 trials  - REDEEM

dabigatran vs placebo

No demonstrated result

Thrombosis prevention

elective major knee surgery :  4 trials  - RE-MOBILIZE (220mg) - RE-MODEL (220mg) - RE-MODEL (150mg) - RE-MOBILIZE (150mg)

dabigatran 150mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 150mg vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 33% (not demonstrated)

suggested distal DVT by 33% (not demonstrated)

dabigatran 220mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 220mg vs enoxaparin (US regimen)

No demonstrated result

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All type of patients:  7 trials  - RE-MOBILIZE (220mg) - RE-MODEL (220mg) - RE-NOVATE (220mg) - RE-MODEL (150mg) - RE-NOVATE (150mg) - RE-MOBILIZE (150mg) - RE-NOVATE 2

dabigatran 150mg vs enoxaparin

No demonstrated result

suggested Symptomatic deep-vein thrombosis by 789% (not demonstrated)

dabigatran 150mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 150mg vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 33% (not demonstrated)

suggested distal DVT by 33% (not demonstrated)

dabigatran 220mg vs enoxaparin

No demonstrated result

dabigatran 220mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 220mg vs enoxaparin (US regimen)

No demonstrated result

Elective hip replacement:  3 trials  - RE-NOVATE (220mg) - RE-NOVATE (150mg) - RE-NOVATE 2

dabigatran 150mg vs enoxaparin

No demonstrated result

suggested Symptomatic deep-vein thrombosis by 789% (not demonstrated)

dabigatran 220mg vs enoxaparin

No demonstrated result

Elective major knee surgery :  4 trials  - RE-MOBILIZE (220mg) - RE-MODEL (220mg) - RE-MODEL (150mg) - RE-MOBILIZE (150mg)

dabigatran 150mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 150mg vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 33% (not demonstrated)

suggested distal DVT by 33% (not demonstrated)

dabigatran 220mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 220mg vs enoxaparin (US regimen)

No demonstrated result

Orthopaedic surgery:  7 trials  - RE-MOBILIZE (220mg) - RE-MODEL (220mg) - RE-NOVATE (220mg) - RE-MODEL (150mg) - RE-NOVATE (150mg) - RE-MOBILIZE (150mg) - RE-NOVATE 2

dabigatran 150mg vs enoxaparin

No demonstrated result

suggested Symptomatic deep-vein thrombosis by 789% (not demonstrated)

dabigatran 150mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 150mg vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 33% (not demonstrated)

suggested distal DVT by 33% (not demonstrated)

dabigatran 220mg vs enoxaparin

No demonstrated result

dabigatran 220mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 220mg vs enoxaparin (US regimen)

No demonstrated result

Orthopedic surgery:  7 trials  - RE-MOBILIZE (220mg) - RE-MODEL (220mg) - RE-NOVATE (220mg) - RE-MODEL (150mg) - RE-NOVATE (150mg) - RE-MOBILIZE (150mg) - RE-NOVATE 2

dabigatran 150mg vs enoxaparin

No demonstrated result

suggested Symptomatic deep-vein thrombosis by 789% (not demonstrated)

dabigatran 150mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 150mg vs enoxaparin (US regimen)

No demonstrated result

suggested total VTE and all-cause mortality by 33% (not demonstrated)

suggested distal DVT by 33% (not demonstrated)

dabigatran 220mg vs enoxaparin

No demonstrated result

dabigatran 220mg vs enoxaparin (europe regimen)

No demonstrated result

dabigatran 220mg vs enoxaparin (US regimen)

No demonstrated result

Venous thrombosis

secondary prevention of VTE :  2 trials  - RE-MEDY - RE-SONATE

dabigatran vs discontinuation

No demonstrated result

suggested VTE by 92% (not demonstrated)

suggested recurrent VTE during treatment by 92% (not demonstrated)

dabigatran vs warfarin

No demonstrated result

suggested major or clinically relevant non-major bleeding by 45% (not demonstrated)

suggested Bleeding by 26% (not demonstrated)

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All type of patients:  1 trials  - RE-COVER

heparin/dabigatran vs heparin/VKA

No demonstrated result

suggested Bleeding by 27% (not demonstrated)

All types of patients:  4 trials  - RE-COVER - RE-COVER II - RE-MEDY - RE-SONATE

dabigatran vs discontinuation

No demonstrated result

suggested VTE by 92% (not demonstrated)

suggested recurrent VTE during treatment by 92% (not demonstrated)

dabigatran vs warfarin

No demonstrated result

suggested major or clinically relevant non-major bleeding by 45% (not demonstrated)

suggested Bleeding by 26% (not demonstrated)

heparin/dabigatran vs heparin/VKA

No demonstrated result

suggested Bleeding by 28% (not demonstrated)