Summary of FDA approvals for conventional anticoagulants and the DOACs and clinical trial experience/evidence in pediatric VTE treatment
| Anticoagulant . | Initial FDA approval (year) . | FDA-approved indications in adults . | Pediatric FDA approval . | Pediatric VTE treatment trial experience . |
|---|---|---|---|---|
| VKA | ||||
| Warfarin | 1954 | Prophylaxis and treatment of venous thrombosis and its extension, PE | None | PK/PD and safety/efficacy |
| Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation/cardiac valve replacement | No RCTs | |||
| Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events after myocardial | ||||
| LMWH | ||||
| Enoxaparin | 1993 | Prophylaxis and treatment of DVT and PE | None | PD and safety/efficacy |
| Prophylaxis of ischemic complications of unstable angina and myocardial infarction | No RCTs | |||
| Dalteparin | 1994 | Prophylaxis of DVT in abdominal surgery, hip replacement, and medical illness with immobility | None | PD and safety/efficacy (small, investigator-initiated) |
| Pentasaccaride | ||||
| Fondaparinux | 2001 | DVT and PE treatment and prophylaxis | None | PD and safety/efficacy (small, investigator-initiated) |
| DOAC | ||||
| Dabigatran | 2010 | Stroke prophylaxis in nonvalvular atrial fibrillation | None | None yet published |
| VTE treatment | VTE treatment | |||
| Reduction in risk of recurrence of VTE in patients previously treated | RCT started in 2013 | |||
| Rivaroxaban | 2011 | DVT and PE prophylaxis in orthopedic surgery | None | None yet published |
| Stroke prophylaxis in nonvalvular atrial fibrillation | VTE treatment RCT started in 2015; phase 1 study published (Abstract)23 | |||
| Apixaban | 2012 | Stroke prophylaxis in nonvalvular atrial fibrillation | None | None yet published |
| DVT and PE prophylaxis in orthopedic surgery (2014) | VTE prevention | |||
| VTE treatment and reduction in risk of recurrence | RCT anticipated to start in 2015 | |||
| Edoxaban | 2015 | Stroke prophylaxis in nonvalvular atrial fibrillation | None | None yet published |
| VTE treatment |
| Anticoagulant . | Initial FDA approval (year) . | FDA-approved indications in adults . | Pediatric FDA approval . | Pediatric VTE treatment trial experience . |
|---|---|---|---|---|
| VKA | ||||
| Warfarin | 1954 | Prophylaxis and treatment of venous thrombosis and its extension, PE | None | PK/PD and safety/efficacy |
| Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation/cardiac valve replacement | No RCTs | |||
| Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events after myocardial | ||||
| LMWH | ||||
| Enoxaparin | 1993 | Prophylaxis and treatment of DVT and PE | None | PD and safety/efficacy |
| Prophylaxis of ischemic complications of unstable angina and myocardial infarction | No RCTs | |||
| Dalteparin | 1994 | Prophylaxis of DVT in abdominal surgery, hip replacement, and medical illness with immobility | None | PD and safety/efficacy (small, investigator-initiated) |
| Pentasaccaride | ||||
| Fondaparinux | 2001 | DVT and PE treatment and prophylaxis | None | PD and safety/efficacy (small, investigator-initiated) |
| DOAC | ||||
| Dabigatran | 2010 | Stroke prophylaxis in nonvalvular atrial fibrillation | None | None yet published |
| VTE treatment | VTE treatment | |||
| Reduction in risk of recurrence of VTE in patients previously treated | RCT started in 2013 | |||
| Rivaroxaban | 2011 | DVT and PE prophylaxis in orthopedic surgery | None | None yet published |
| Stroke prophylaxis in nonvalvular atrial fibrillation | VTE treatment RCT started in 2015; phase 1 study published (Abstract)23 | |||
| Apixaban | 2012 | Stroke prophylaxis in nonvalvular atrial fibrillation | None | None yet published |
| DVT and PE prophylaxis in orthopedic surgery (2014) | VTE prevention | |||
| VTE treatment and reduction in risk of recurrence | RCT anticipated to start in 2015 | |||
| Edoxaban | 2015 | Stroke prophylaxis in nonvalvular atrial fibrillation | None | None yet published |
| VTE treatment |
DVT, deep venous thrombosis; PE, pulmonary embolism.