Efient* 5 mg film-coated tablets. Efient 10mg film-coated t(五)
I was eva luated in one clopidogrel-controlled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months, 4136 patients were treated for more than 1 year). The rate of study drug discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel. Of these, bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation (2.5% for prasugrel and 1.4% for clopidogrel).
Bleeding
Non-Coronary Artery Bypass Graft (CABG) related bleeding
In TRITON, the frequency of patients experiencing a Non-CABG-related bleeding event is shown in Table 1. The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/NSTEMI and all ACS populations. No significant difference was seen in the STEMI population. The most common site of spontaneous bleeding was the gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with clopidogrel).
Table 1: Incidence of Non-CABG-related bleedinga (% Patients)
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.
Patients 75 years old
In the phase 3 clinical trial, Non-CABG-related TIMI major or minor bleeding rates for patients in two age groups were as follows:
Patients < 60 kg
In the phase 3 clinical trial, Non-CABG-related TIMI major or minor bleeding rates for patients in two weight groups were as follows:
In patients 60 kg and age <75 years, Non-CABGrelated TIMI major or minor bleeding rates were 3.6% for prasugrel and 2.8% for clopidogrel; rates for fatal bleeding were 0.2% for prasugrel and 0.1% for clopidogrel.
CABG-related bleeding
In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study. Of those patients, the rate of CABG-related TIMI major or minor bleeding was 14.1% for the prasugrel group and 4.5% in the clopidogrel group. The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug. For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the clopidogrel group. Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
b. Tabulated summary of adverse reactions
Table 2 summa |
