Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University.
Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka.
J Hypertens. 2021 Jul 1;39(7):1435-1443. doi: 10.1097/HJH.0000000000002823.
Intensive lipid-lowering therapy is recommended in type 2 diabetes mellitus (T2DM) patients with target organ damage. However, the evidence is insufficient to stratify the patients who will benefit from the intensive therapy among them. High visit-to-visit variability in systolic blood pressure (SBP) is associated with increased risk of cardiovascular events. We investigated the effectiveness of intensive versus standard statin therapy in the primary prevention of cardiovascular events among T2DM patients with retinopathy stratified by visit-to-visit SBP variability.
The standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy study was the first trial comparing statin intensive therapy targeting low-density lipoprotein cholesterol (LDL-C) <70 mg/dl and standard therapy targeting LDL-C ≥100 to <120 mg/dl in T2DM patients with retinopathy without known cardiovascular disease. Using this dataset, we divided the patients into two subpopulations based on standard deviation (SD) and average real variability (ARV) of clinic SBP within the initial 6 months.
In a total of 4899 patients, 240 composite cardiovascular events were observed during a median follow-up of 37.3 months. In multivariable-adjusted model comparing intensive versus standard therapy, the hazard ratios for composite cardiovascular events were 0.64 (95% CI 0.45-0.90) and 1.21 (95% CI 0.82-1.80) in patients with high and low SBP variability as defined by SD, respectively. Interaction between SBP variability and statin therapy was significant (P = 0.018). The analysis using ARV of SBP showed similar results.
Statin intensive therapy targeting LDL-C <70 mg/dl had benefits in primary prevention of cardiovascular events compared with standard therapy among T2DM patients with retinopathy having high, but not low, visit-to-visit SBP variability.
有靶器官损伤的 2 型糖尿病（T2DM）患者推荐强化降脂治疗。然而，目前的证据尚不足以对其中将从强化治疗中获益的患者进行分层。收缩压（SBP）的随访间变异性高与心血管事件风险增加相关。我们研究了根据视网膜病变患者 SBP 随访间变异性将患者分层后，强化与标准他汀类药物治疗在 T2DM 患者心血管事件一级预防中的疗效。
标准与强化他汀类药物治疗糖尿病视网膜病变患者试验是首个比较他汀类药物强化治疗（目标 LDL-C<70mg/dl）与标准治疗（目标 LDL-C≥100但<120mg/dl）的试验，适用于无已知心血管疾病的伴有视网膜病变的 T2DM 患者。利用该数据集，我们根据初始 6 个月内诊所 SBP 的标准差（SD）和平均真实变异性（ARV）将患者分为两个亚组。
在总共 4899 例患者中，在中位随访 37.3 个月期间观察到 240 例复合心血管事件。在多变量调整模型中，与标准治疗相比，SD 定义的 SBP 高变异性和低变异性患者的复合心血管事件风险比分别为 0.64（95%CI 0.45-0.90）和 1.21（95%CI 0.82-1.80）。SBP 变异性与他汀类药物治疗之间的交互作用具有统计学意义（P=0.018）。SBP 变异性的 ARV 分析也得到了相似的结果。
与标准治疗相比，LDL-C<70mg/dl 的他汀类药物强化治疗在伴有高而非低 SBP 随访间变异性的伴有视网膜病变的 T2DM 患者中具有心血管事件一级预防的益处。
