Educational Event 23 rd & 24 th January 2013 West Suffolk Hospital Education Centre

New Oral Anticoagulants (NOACs) Dabigatran and Rivaroxaban

for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation Clinical Overview & NICE TA Guidance Emma Harris Medicines Management Pharmacist West Suffolk Clinical Commissioning Group

Clinical Overview of the NOACs

Prophylaxis of stroke and systemic embolism in nonvalvular AF •

Dabigatran etexilate

 prodrug  rapidly absorbed after oral administration and converted to dabigatran  direct thrombin inhibitor •

Rivaroxaban

 direct factor Xa inhibitor

Rivaroxaban Factor Xa Prothrombin (Factor II) Dabigatran Thrombin (Factor IIa) Fibrinogen (Factor I) Fibrin

Dabigatran etexilate

• Pradaxa® capsules 75mg, 110mg, 150mg • Dose (AF): 

150mg BD

 110mg BD Age ≥80 years Concomitant verapamil High risk of bleeding

Dabigatran etexilate

• Dose (AF): 

110mg or 150mg BD

Age 75-80 years Moderate renal impairment (avoid if CrCl<30mL/min) Gastritis, Oesophagitis, GORD Other patients at increased risk of bleeding

Rivaroxaban

• Xarelto® tablets 10mg, 15mg, 20mg • Dose (AF): 

20mg OD



15mg OD

Moderate/Severe renal impairment (avoid if CrCl<15mL/min)

NICE Technology Appraisal Guidance 249

March 2012 Dabigatran etexilate for the prevention of stroke and systemic embolism in AF Recommended as an option in people with nonvalvular AF with one or more of the following risk factors: • previous stroke, transient ischaemic attack or systemic embolism • left ventricular ejection fraction below 40%

NICE Technology Appraisal Guidance 249

• symptomatic heart failure of NYHA ≥class 2 • age 75 years or older • age 65 years or older with one of the following: diabetes mellitus coronary artery disease hypertension • Informed discussion between clinician and patient on the risks and benefits of:  dabigatran compared to warfarin  switching to dabigatran from warfarin

NICE Technology Appraisal Guidance 256

May 2012 Rivaroxaban for the prevention of stroke and systemic embolism in people with AF Recommended as an option in people with nonvalvular AF with one or more risk factors such as: • • • • • congestive heart failure hypertension age 75 years or older diabetes mellitus prior stroke or transient ischaemic attack

NICE Technology Appraisal Guidance 256

• Informed discussion between clinician and patient on the risks and benefits of:  rivaroxaban compared to warfarin  switching to rivaroxaban from warfarin