Table ES-3Summary of findings for KQ—4 adverse effects

OutcomeStrength of EvidenceSummary
Drug discontinuation due to adverse effectsLowAcross all indications, discontinuation due to adverse effects was higher with newer oral anticoagulants (RR 1.23; 95% CI, 0.94 to 1.61), but the 95-percent CI was large and included no effect. In subgroup analysis, rates of discontinuation were higher for dabigatran compared with FXa inhibitors. A clinically important increase in drug discontinuation compared with warfarin cannot be excluded.
Major bleedingLowAcross all indications, the risk of major bleeding was lower with newer oral anticoagulants (RR 0.86; 95% CI, 0.71 to 1.04), but the 95-percent CI was large and included no effect. A clinically important decrease in major bleeding compared with warfarin cannot be excluded. In December 2011, the FDA issued a notice that it was evaluating reports of serious bleeding with dabigatran.
Fatal bleedingModerateAcross all indications, the risk of fatal bleeding was lower with newer oral anticoagulants (RR 0.59; 95% CI, 0.46 to 0.77). Risk difference was 1 fewer death per 1000 patients.
Gastrointestinal bleedingModerateAcross all indications, the risk of gastrointestinal bleeding was increased with newer oral anticoagulants (RR 1.30; 95% CI, 1.17 to 1.49). Risk difference was 1 additional gastrointestinal bleed per 1000 patients.
Myocardial infarctionLowAcross all indications, the risk of myocardial infarction was not different with newer oral anticoagulants (RR 1.02; 95% CI, 0.76 to 1.39). In a subgroup analysis, the risk was increased with dabigatran (RR 1.35; CI, 0.99 to 1.85) compared with FXa inhibitors (RR 0.86; CI, 0.66 to 1.11); p = 0.03 for between-group comparison.
Liver dysfunctionModerateAcross all indications, the risk of liver dysfunction was not different with newer oral anticoagulants (RR 0.82; 95% CI, 0.61 to 1.11).

From: EXECUTIVE SUMMARY

Cover of Comparative Effectiveness of Warfarin and Newer Oral Anticoagulants for the Long-Term Prevention and Treatment of Arterial and Venous Thromboembolism
Comparative Effectiveness of Warfarin and Newer Oral Anticoagulants for the Long-Term Prevention and Treatment of Arterial and Venous Thromboembolism [Internet].
Adam SS, McDuffie JR, Ortel TL, et al.
Washington (DC): Department of Veterans Affairs (US); 2012 Apr.

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