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Low LDL Target Resulted in No Clinical Gain in Non-CAD Diabetes: EMPATHY

Cardiovascular risk did not drop significantly over 3 years with intensive statin therapy, compared with a standard statin regimen, in a randomized trial that entered only dyslipidemic patients with diabetic retinopathy but no history of coronary disease.

In the Japan-based EMPATHY trial with >5000 patients, reduction in risk of a wide-ranging cardiovascular primary end point was 16% (P=0.15) for statin therapy to an LDL-C target of <70 mg/dL, compared with a target range >100 but <120 mg/dL.

On the other hand, the risk of cerebral infarction, a secondary end point, fell by nearly half (P=0.02) in the group with the lower LDL-C target. And in a post hoc analysis limited to patients in either study arm who, on average, actually achieved their LDL-C targets, risk of the primary end point fell by 52% (P=0.007).

Thus achieving LDL-cholesterol below 70 mg/dL in a treat-to-target strategy in high-risk patients with hypercholesterolemia and diabetic retinopathy may have benefit and deserves further investigation.


  1. Ueshima K, Itoh H, Kanazawa N, et al. Rationale and design of the standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy (EMPATHY) study: A randomized controlled trial. J Atheroscler Thromb 2016; 23:976-990.