Key result
Dabigatran 110 mg reduces minor bleeding ~19% vs 150 mg, with similar major bleeding rates.
Why the study?
Does dabigatran 110 mg reduce bleeding events compared to dabigatran 150 mg in patients with atrial fibrillation?
Meta-Analysis (n=29,264)
Does dabigatran 110 mg reduce bleeding events compared to dabigatran 150 mg in patients with atrial fibrillation?
Odds Ratio: 1.19 (95% CI 1.1–1.27)
p-value: p=<0.00001
In patients with atrial fibrillation, dabigatran 110 mg reduces minor bleeding compared to 150 mg, but the 150 mg dose is associated with significantly lower mortality, with no difference in major or fatal bleeding.
Supports 110 mg dabigatran to reduce minor bleeding risk; reinforces dose-specific safety data from prior trials.
BACKGROUND: The newer oral anticoagulant dabigatran is considered to be more beneficial in patients with non-valvular Atrial Fibrillation (AF) when compared to warfarin. However, because bleeding events which are associated with a low dose (110 mg) versus a high dose (150 mg) of dabigatran have seldom been compared, we aimed to systematically solve this important issue through this meta-analysis. METHODS: English publications comparing 110 mg with 150 mg dabigatran in patients who were treated for AF were electronically searched through medical databases. Bleeding outcomes were the major clinical endpoints to be assessed. Odds Ratios (OR) and 95% Confidence Intervals (CIs) for each subgroup were calculated and the main analysis was carried out by the latest version of the RevMan 5.3 software. RESULTS: Twenty-nine thousand two hundred and sixty-four (29,264) patients were included in this meta-analysis. Fifteen thousand eight hundred and forty-eight (15,848) patients were treated with 110 mg dabigatran whereas 13,416 patients were treated with 150 mg dabigatran. 110 mg dabigatran was associated with a significantly lower rate of minor bleeding (OR: 1.19, 95% CI: 1.10-1.27; P < 0.00001). A similar rate of fatal and major bleeding was observed with both dosages (OR: 1.12, 95% CI: 0.69-1.82; P = 0.65) and (OR: 1.09, 95% CI: 0.86-1.37; P = 0.49) respectively. However, ischemic stroke insignificantly favored a higher dose of dabigatran, (OR: 0.77, 95% CI: 0.51-1.16; P = 0.21). In addition, this analysis showed mortality to significantly favor 150 mg of dabigatran (OR: 0.41, 95% CI: 0.34-0.50; P < 0.00001). CONCLUSION: No significant differences in major and fatal bleedings were observed with 110 mg versus 150 mg dabigatran. However, 110 mg dabigatran was associated with a significantly lower risk of minor bleeding. These results should further be confirmed in future trials.
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Bundhun et al. (2017) conducted a meta-analysis in Non-valvular Atrial Fibrillation (n=29,264). Dabigatran vs. Dabigatran 150 mg was evaluated on Minor bleeding (OR 1.19, 95% CI 1.10-1.27, p=<0.00001). Dabigatran 110 mg was associated with a significantly lower risk of minor bleeding (OR 1.19) compared to 150 mg, with no significant differences observed in major or fatal bleeding.
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