Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Efient

Efient 10 mg film-coated tablets. Efient 5 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 7–8

HOS-120783 · Präparat HOS-095209

7 Table 1: Incidence of Non-CABG related bleedinga (% Patients) Event All ACS UA/NSTEMI STEMI Prasugrelb Clopidogrelb Prasugrelb Clopidogrelb Prasugrelb Clopidogrelb +ASA +ASA +ASA +ASA +ASA +ASA (N=6741) (N=6716) (N=5001) (N=4980) (N=1740) (N=1736) TIMI major 2.2 1.7 2.2 1.6 2.2 2.0 bleedingc Life-threateningd 1.3 0.8 1.3 0.8 1.2 1.0 Fatal 0.3 0.1 0.3 0.1 0.4 0.1 Symptomatic 0.3 0.3 0.3 0.3 0.2 0.2 ICHe Requiring 0.3 0.1 0.3 0.1 0.3 0.2 inotropes Requiring 0.3 0.3 0.3 0.3 0.1 0.2 surgical intervention Requiring 0.7 0.5 0.6 0.3 0.8 0.8 transfusion (≥ 4 units) TIMI minor 2.4 1.9 2.3 1.6 2.7 2.6 bleeding f a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria. b Other standard therapies were used as appropriate. c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥ 5 g/dL. d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below. Patients may be counted in more than one row. e ICH=intracranial haemorrhage. f Clinically overt bleeding associated with a fall in haemoglobin of ≥ 3 g/dL but < 5 g/dL.

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