Intensive
lipid-lowering
therapy is recommended in individuals exhibiting
type 2 diabetes mellitus (T2DM) with microvascular complications (as high-risk patients), even without known
cardiovascular disease (CVD). However, evidence is insufficient to stratify the patients who would benefit from intensive
therapy among them.
Hypertension is a major risk factor, and uncontrolled blood pressure (BP) is associated with increased CVD risk. We evaluated the efficacy of intensive vs. standard
statin therapy for primary CVD prevention among T2DM patients with retinopathy stratified by BP levels. We used the dataset from the EMPATHY study, which compared intensive
statin therapy targeting
low-density lipoprotein cholesterol (
LDL-C) levels of <70 mg/dL and standard
therapy targeting
LDL-C levels ranging from ≥100 to <120 mg/dL in T2DM patients with retinopathy without known CVD. A total of 4980 patients were divided into BP ≥ 130/80 mmHg (systolic BP ≥ 130 mmHg and/or diastolic BP ≥ 80 mmHg, n = 3335) and BP < 130/80 mmHg (n = 1645) subgroups by baseline BP levels. During the median follow-up of 36.8 months, 281 CVD events were observed. Consistent with previous studies, CVD events occurred more frequently in the BP ≥ 130/80 mmHg subgroup than in the BP < 130/80 mmHg subgroup (P < 0.001). In the BP ≥ 130/80 mmHg subgroup, intensive
statin therapy was associated with lower CVD risk (HR 0.70, P = 0.015) than standard
therapy after adjustment. No such association was observed in the BP < 130/80 mmHg subgroup. The interaction between BP subgroup and
statin therapy was significant. In conclusion, intensive
statin therapy targeting
LDL-C < 70 mg/dL provided benefits in primary CVD prevention when compared with standard
therapy among T2DM patients with retinopathy and BP ≥ 130/80 mmHg.