NICE guidance - dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation (AF)

Last reviewed 01/2018

Dabigatran etexilate is recommended as an option for the prevention of stroke and systemic embolism within its licensed indication, that is, in people with nonvalvular atrial fibrillation with one or more of the following risk factors:

• previous stroke, transient ischaemic attack or systemic embolism
  
  
• left ventricular ejection fraction below 40%
  
  
• symptomatic heart failure of New York Heart Association (NYHA) class 2 or above
  
  
• age 75 years or older
  
  
• age 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension

Decision about whether to start treatment with dabigatran etexilate should be made after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin

• for people who are taking warfarin, the potential risks and benefits of switching to dabigatran etexilate should be considered in light of their level of international normalised ratio (INR) control

Notes:

• summary of product characteristics states that the recommended daily dose of dabigatran is 300 mg taken as one 150 mg capsule twice daily. Therapy is continued long term
  • for patients aged 75-80 years, a dose of 220 mg taken as one 110 mg capsule twice daily can be considered at the discretion of the physician for individual patients whose thromboembolic risk is low and bleeding risk is high
  • patients aged 80 years or older should be treated with a daily dose of 220 mg taken as one 110 mg capsule twice daily because of the increased risk of bleeding in this population
    
    
• dabigatran is contraindicated in people with severe renal impairment, active clinically significant bleeding, organic lesions at risk of bleeding, impairment of haemostasis, and hepatic impairment or liver disease expected to have an impact on survival
  • concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole or tacrolimus is also contraindicated
  • most common adverse events in people receiving dabigatran are anaemia, abdominal pain, diarrhoea, dyspepsia, gastrointestinal haemorrhage, genitourinary haemorrhage (patients may notice blood in their urine), nausea and nose bleed
    
    
• not recommended if (2)
  • FBC: Platelets <70 x109/l
  • eGFR <= 30 ml/min
  • LFT: Liver enzymes elevated >2x normal
  • coagulation Screen: APTT >1.5x normal; INR >1.4
    
    

• Dabigatran is contraindicated in patients with prosthetic heart valure requiring anticoagulant treatment (3)

Reference:

• 1) NICE (March 2012). Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation
• 2) Coventry & Warwickshire Area Prescribing Committee (May 2012). Specialist Initiated Drug Checklist - Dabigatran
• 3) Boehringer Ingelheim (4/1/2013). Safety information notice - DHPC/Pradaxa/II44/UK