| 431 | For the prevention of stroke and systemic embolism in at risk patients with non-valvular atrial fibrillation (AF), AND in whom:
1) Anticoagulation is inadequate following a reasonable trial on warfarin; OR
2) Anticoagulation with warfarin is contraindicated or not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy, and at home).
Exclusion Criteria:
Impaired renal function (creatinine clearance or estimated glomerular filtration rate less than 30mL/min); OR greater than or equal to 75 years of age without documented stable renal function; OR hemodynamically significant rheumatic valvular heart disease, especially mitral stenosis; OR prosthetic heart valves.
Note:
(a) Documented stable renal function is defined as creatinine clearance or estimated glomerular filtration rate maintained for at least 3 months (i.e., 30-49mL/min for 110mg twice daily dosing and, greater than or equal to 50mL/min for 150mg twice daily dosing for at least 3 months).
(b) At risk patients with atrial fibrillation are defined as those with a CHADS2 score of greater than or equal to 1.
(c) Inadequate anticoagulation is defined as INR testing results that are outside of the desired INR range for at least 35% of the tests during the monitoring period (i.e., adequate anticoagulation is defined as INR test results that are within the desired INR range for at least 65% of the tests during the monitoring period).
(d) A reasonable trial on warfarin is defined as at least 2 months of therapy.
(e) Since renal impairment can increase bleeding risk, renal function should be regularly monitored. Other factors that increase bleeding risk should also be assessed and monitored (see product monograph).
(f) Patients starting dabigatran should have ready access to appropriate medical services to manage a major bleeding event.
(g) There are currently no data to support that dabigatran provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves; dabigatran is not recommended in these populations.
|
