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.

对于患有 2 型糖尿病 (T2DM) 并伴有微血管并发症的个体（作为高危患者），即使没有已知的心血管疾病 (CVD)，建议进行强化降脂治疗。然而，证据不足以对将从强化治疗中受益的患者进行分层。高血压是主要的危险因素，不受控制的血压 (BP) 与心血管疾病风险增加有关。我们评估了强化与标准他汀类药物治疗对 2 型糖尿病视网膜病变患者一级 CVD 预防的疗效，这些患者的视网膜病变按 BP 水平分层。我们使用了 EMPATHY 研究的数据集，该研究比较了针对低密度脂蛋白胆固醇 (LDL-C) 水平 <70 mg/dL 的强化他汀类药物治疗和针对 LDL-C 水平从≥100 到 < 120 mg/dL 在患有视网膜病变且无已知 CVD 的 T2DM 患者中。共有 4980 名患者被分为 BP ≥ 130/80 mmHg（收缩压 ≥ 130 mmHg 和/或舒张压 ≥ 80 mmHg，n  = 3335) 和 BP < 130/80 mmHg ( n  = 1645) 亚组（按基线 BP 水平划分）。在 36.8 个月的中位随访期间，观察到 281 起 CVD 事件。与之前的研究一致，与 BP < 130/80 mmHg 亚组相比，BP ≥ 130/80 mmHg 亚组发生 CVD 事件的频率更高（P  < 0.001）。在 BP ≥ 130/80 mmHg 亚组中，强化他汀类药物治疗与较低的 CVD 风险相关（HR 0.70，P  = 0.015) 比调整后的标准治疗。在 BP < 130/80 mmHg 亚组中未观察到这种关联。BP 亚组与他汀类药物治疗之间的相互作用是显着的。总之，与标准治疗相比，在患有视网膜病变和 BP ≥ 130/80 mmHg 的 T2DM 患者中，针对 LDL-C < 70 mg/dL 的强化他汀类药物治疗在 CVD 一级预防方面提供了益处。