and had been hospitalized for ACS.
Murphy and colleagues found
1-month low-density lipoprotein cholesterol (LDL-C) levels were lowest in
those without a subsequent primary
endpoint event and highest in those
with more than one event. However,
there was no difference in LDL-C lev-
Bleeding Related to CABG – In TRITON-TIMI 38, 437 patients who received a thienopyridine
underwent CABG during the course of the study. The rate of CABG-related TIMI Major or
Minor bleeding was 14.1% for the Effient group and 4.5% in the clopidogrel group (see
Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient
persisted up to 7 days from the most recent dose of study drug.
Table 3: CABG-Related Bleedinga (TRITON-TIMI 38)
Effient (%)
Clopidogrel (%)
(N=213)
(N=224)
TIMI Major or Minor bleeding
14.1
4.5
TIMI Major bleeding
11.3
3.6
Fatal
0.9
0
Reoperation
3.8
0.5
Transfusion of ≥5 units
6.6
2.2
Intracranial hemorrhage
0
0
TIMI Minor bleeding
2.8
0.9
a
Patients may be counted in more than one row.
Bleeding Reported as Adverse Reactions – Hemorrhagic events reported as adverse
reactions in TRITON-TIMI 38 were, for Effient and clopidogrel, respectively: epistaxis (6.2%,
3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous
hematoma (0.5%, 0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal
hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and
retinal hemorrhage (0.0%, 0.1%).
Malignancies: During TRITON-TIMI 38, newly-diagnosed malignancies were reported
in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The
sites contributing to the differences were primarily colon and lung. In another Phase 3
clinical study of ACS patients not undergoing PCI, in which data for malignancies were
prospectively collected, newly-diagnosed malignancies were reported in 1.8% and 1.7% of
patients treated with prasugrel and clopidogrel, respectively. The site of malignancies
was balanced between treatment groups except for colorectal malignancies. The rates
of colorectal malignancies were 0.3% prasugrel, 0.1% clopidogrel and most were
detected during investigation of GI bleed or anemia. It is unclear if these observations
are causally-related, are the result of increased detection because of bleeding, or are
random occurrences.
Other Adverse Events: In TRITON-TIMI 38, common and other important non-hemorrhagic
adverse events were, for Effient and clopidogrel, respectively: severe thrombocytopenia
(0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic
reactions (0.36%, 0.36%), and angioedema (0.06%, 0.04%). Table 4 summarizes the
adverse e fV