Demographic information extracted from FAERS on NOACs and warfarin
| Drug | Number of reports* | DILI reports(%total reports) | Age(%F/M) | Age(mean) (years) | Age>65 years(%on total reports) | Main recorded indications(%out of missing data) | Reporter country(%) |
|---|---|---|---|---|---|---|---|
| Dabigatran (Q3-2010 to Q3-2013) | 13 096 | 222 (1.7%) | 51/49 | 75 | 10 976 (84%) | Atrial fibrillation (84%), cerebrovascular accident prophylaxis (9%), anticoagulant therapy (5%), thrombosis prophylaxis (3%), other (1% each). Missing data in 9%. | US (68), EU (15), other (12), missing (5) |
| Rivaroxaban (Q3-2011 to Q3-2013) | 3985 | 146 (3.7%) | 52/48 | 71 | 2907 (73%) | Atrial fibrillation (49%), cerebrovascular accident prophylaxis (38%), thrombosis prophylaxis (23%), unknown indication (19%), knee arthroplasty and DVT (9%), hip arthroplasty (5%). Missing data in 2%. | US (53), EU (38), other (9) |
| Apixaban (Q1-2013 to Q3-2013) | 16 | 1 (6.3%) | 69/31 | 77 | 14 (88%) | Thrombosis prophylaxis (57%), unknown indication (57%), percutaneous coronary intervention (21%), atrial fibrillation (9%). Missing data in 13%. | US (50), EU (50) |
| Warfarin (Q1-2004 to Q2-2010) | 9242 | 235 (2.5%) | 42/58 | 69 | 6086 (66%) | Atrial fibrillation (47%), unknown indication (29%), DVT (14%), thrombosis prophylaxis (12%), anticoagulant therapy (11%), pulmonary embolism (9%). Missing data in 15%. | US (62), EU (14), other (5), missing (19) |
| Warfarin (Q3-2010 to Q3-2013) | 4068 | 94 (2.3%) | 43/57 | 71 | 2868 (71%) |
DVT, deep vein thrombosis.
*
Number of reports recorded for each drug under study (i.e. dabigatran, rivaroxaban, apixaban, warfarin) according to the period of interest.