This document summarizes the properties and uses of the new oral anticoagulant Dabigatran. It notes that Dabigatran has been approved by the FDA to reduce risks of blood clots in knee or hip replacement surgery and atrial fibrillation. The recommended dosages are 150mg twice daily for high stroke risk or 110mg twice daily for high bleeding risk. Side effects include high costs, lack of an antidote currently, and possible increased heart attack risk or gastrointestinal bleeding. The document concludes that NOACs like Dabigatran have a favorable benefit-risk profile compared to warfarin but that individualized treatment is still important based on patient characteristics, and more clinical experience is

1. Dr. Hasan Mahmud Iqbal.

2. Old Anticoagulant:
Warfarin (Inhibit formation of
Factor II, VII, IX, X)
New oral anticoagulants
1. Debigatran
2. Rivaroxaban
3. Apixaban

3. ???

4.  Drug or food interactions
 Need regular monitoring to adjust doses
 Slow onset of action
 Narrow therapeutic window
 Difficult to manage invasive procedures

6.  To reduce the risk of DVTs and PEs in
patients undergoing knee or hip
replacement surgery. (Jul 1, 2011 FDA)
 For prevention of thromboembolism and
stroke in patients with nonvalvular atrial
fibrillation. (Nov 4, 2011 FDA)
 Treatment of deep vein thrombosis (DVT)
and pulmonary embolism (PE), as well as to
reduce the risk of recurrent DVT and PE .
(Nov 2, 2012 FDA)

7.  Therapeutic dose : 20 mg once daily
 Prophylactic dose : 10 mg once daily
 No specific dose adjustment advised in
moderate renal function impairment but
should be used with caution.
Contraindicated in severe renal impairment
No dose adjustment is required for body
weight

8. To reduce the risk of stroke and
dangerous blood clots (systemic embolism) in
patients with atrial fibrillation that is not
caused by a heart valve problem.
(Dec 28, 2012. FDA)

9. 1. The recommended dose 5 mg taken
orally twice daily.
2. The recommended dose is 2.5 mg twice
daily in patients with any 2 of the following
characteristics:
• age ≥80 years
• body weight ≤60 kg
• serum creatinine ≥1.5 mg/dL

10.  Reduction of Risk of Stroke and Systemic
Embolism in Non-valvular Atrial Fibrillation
 Treatment of Deep Venous Thrombosis and
Pulmonary Embolism…
Those patients who have been treated
with a parenteral anticoagulant for 5-10
days.
 Reduction in the Risk of Recurrence of
Deep Venous Thrombosis and Pulmonary
Embolism

11. DOSES:
High risk of stroke(high CHADS-VASC score)
- Dabigatran 150 mg BID
High risk of bleeding or previous life-
threatening bleedings:
- Dabigatran 110 mg BID
CONTRAINDICATION:
“Recently the FDA added a
contraindication to the dabigatran label
against using the drug in patients with
mechanical heart valves”
[12/19/2012 - FDA]

12.  Cost is high
 No antidote available right now
though can be removed by dialysis.
New antidote is under phase II trial.
 Possibly increased risk of MI
 Major GI bleeding may be higher.

13.  NOACs have a favourable balance
between efficacy and safety compared with
warfarin.
 Individualized anticoagulant treatment
should be considered.
ie Age, RFT, Clinical situation.
 NOACs future depends upon clinical
experience, patients’tolerance, antidote,
data from further studies.

14. THANK YOU