HIJ-PROPER: No Significant Difference in Intensive vs. Standard Statin Treatment for ACS, Dyslipidemia Patients
In patients with acute coronary syndrome (ACS) and dyslipidemia, use of a second-line cholesterol-lowering medication on top of a standard statin did not significantly reduce survival and other cardiovascular outcomes compared to statin treatment alone, according to results from the HIJ-PROPER Trial presented Aug. 29 at ESC Congress 2016 in Rome.
The study, led by Nobuhisa Hagiwara, MD, PhD, et al., looked at 1,734 patients from 19 hospitals in Japan. Patients underwent coronary angiography and were randomized to receive either an intensive cholesterol-lowering combination of statin (pitavastatin) plus ezetimibe (with a target low-density lipoprotein cholesterol (LDL-C) level of ≤ 70 mg/dL), or pitavastatin alone (with an LDL-C target of 90 to 100 mg/dL).
Results showed that after a three-year follow-up, the intensive treatment “was not associated with significantly better rates of the primary endpoint” – a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting (hazard ratio 0.89, 95 percent confidence interval 0.76-1.04, P=0.152).
However, the authors note that a subgroup of patients with higher baseline levels of the cholesterol absorption marker sitosterol (median value more than 2.2 µg/mL) did show “significant benefit” from the intensive treatment.
“Although the results from our study were negative, they also suggest a potentially interesting direction for future research,” said Hagiwara. “Based on these findings we should next assess whether evaluating cholesterol absorption markers might be a potentially new way to personalize cholesterol treatment strategies in a real-world clinical setting.”
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