A treat-to-target approach to helping high-risk patients with hypercholesterolemia and diabetic retinopathy lower their low-density lipoprotein (LDL) cholesterol below 70 mg/dl may be beneficial in reducing cardiovascular and cerebral events, based on data from the EMPATHY trial presented at ESC Congress 2017 in Barcelona.

The study randomly assigned 5,042 Japanese patients with hypercholesterolemia, diabetic retinopathy and no history of coronary artery disease to intensive or standard statin monotherapy with any statin for a maximum of 5.5 years. The average follow up was 37 months. LDL cholesterol targets were below 70 mg/dl for the intensive therapy group and 100 to 120 mg/dl for the standard therapy group. The primary and secondary endpoints were the combined incidence of cardiovascular events or death and incidence of cerebral events, respectively.

Unlike the results from previous Western trials, data from EMPATHY showed no significant reduction of cardiac events. The primary endpoint was not significantly reduced by intensive statin therapy (hazard ratio [HR], 0.84; 95 percent confidence interval [CI], 0.67-1.07; p = 0.15).  However, study investigators did highlight post-hoc analysis in subgroups of patients who achieved their LDL cholesterol targets showing the primary endpoint was significantly reduced by intensive statin-based lipid lowering (HR, 0.48; 95 percent CI, 0.28-0.82; p = 0.007). Additionally, intensive therapy was found to significantly reduce the secondary endpoint of cerebral events (cerebral infarction or cerebral revascularization) (HR, 0.52; 95 percent CI, 0.31-0.88; p = 0.01), particularly cerebral infarction (HR, 0.54; 95 percent CI, 0.32-0.90; p = 0.02).

Hiroshi Itoh, MD, of the Keio University School of Medicine, Tokyo, Japan, said the differences between other trial results and EMPATHY may be due in part to the low number of cardiac events in the study. “During 5.5 years of follow-up there were more cerebral events than cardiac events, which is typical of Asian populations,” Itoh said.

Despite not meeting the primary endpoint, Itoh and the other study investigators suggest their post-hoc analysis findings warrant further research into whether the intensive treat-to-target approach is truly useful to this high-risk patient population. “If so,” said Itoh, “[we need to find] how to make that treatment goal accessible to more patients in a clinical setting.”

Keywords: ESC Congress, ESC2017, Cholesterol, LDL, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Coronary Artery Disease, Diabetic Retinopathy, Japan, Cerebral Revascularization, Tokyo, Cerebral Infarction, Medicine

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