Outcome Measures and Follow-Up
The effectiveness outcome measures in this study included: (1) a primary
composite outcome of CVD-associated death, non-fatal ACS, and non-fatal
stroke within 1 month and within 12 months of discharge among
high-intensity statin naïve patients who were discharged on either
atorvastatin 40mg or 80mg; (2) secondary effectiveness outcomes,
including, all-cause mortality, CV mortality, fatal or non-fatal stroke,
fatal or non-fatal ACS, coronary revascularization, stent thrombosis,
and stent restenosis within 1 month and 12 months post-discharge and;
(3) lowering LDL-C by ≥ 50% from baseline or LDL-C < 70mg/dL.
On the other hand, the safety outcome measures of the study
included: (1) myopathy; (2) rhabdomyolysis; (3) elevation of
ALT or AST > three upper limits of normal and; (4) any
adverse drug event requiring statin discontinuation. Predictors of
prescribing atorvastatin 80mg among ACS patients, including several
patient-related, disease-related, and medication-related factors, such
as demographics, comorbid diseases, and concomitant prescription drugs
during hospitalization were also measured. Patients were followed-up for
1 year post-discharge date, or until the occurrence of the primary
endpoint, or until censoring if they were lost to follow-up.