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Exact(12)
The largest observed major bleeding rate in observational studies occurred in the largest study.
This finding is consistent with the median major bleeding rate observed across our included studies (2.0 per 100 patient-years).
The major bleeding rate and total bleeding rate were significantly higher in the GP IIb/IIIa group, though the minor bleeding rate was not significantly different.
34 In Matisse trials, at therapeutic dose of 7.5 mg/day, bleeding risk of fondaparinux was comparable with therapeutic doses of UFH or LMWH (major bleeding rate of 1.1%1.3%% for all three substances).
In the probability analysis the hierarchy for treatment safety for major bleeding rate was (highest to lowest) bivalirudin, followed by unfractionated heparin, LMWH plus GpIIb/IIIa inhibitor, unfractionated heparin plus GpIIb/IIIa inhibitor, and fondaparinux (supplementary fig 7).
Two early review articles summarized that warfarin therapy resulted in major bleeding rate in an average of 1.7%to3%3% of patients per year, and fatal bleeding in 0.6% to 0.8% of patients per year [ 50, 51].
Similar(48)
However, the major bleeding rates in the RECORD studies without excluding major wound bleedings were reported in an FDA review, 38 and were similar to the major bleeding rates of the remaining studies.
Major bleeding rates were available in all studies (n=32 287).
Major bleeding rates were decreased with high- and low-dose edoxaban compared with warfarin [ 25].
There was no difference in major bleeding rates between the groups.
Major bleeding rates were 6.9%, 7.1%, and 5.1%, respectively (P = 0.91 and P = 0.35, respectively, vs clopidogrel).
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