■动脉粥样硬化血脂异常,这通常与2型糖尿病(T2D)和胰岛素抵抗有关,有助于血管并发症的发展。他汀类药物治疗是T2D血脂异常管理的主要方法,然而,非他汀类药物治疗的作用尚不清楚.依泽替米贝通过抑制肠道胆固醇吸收来降低胆固醇负担。纤维蛋白通过过氧化物酶体增殖物激活的受体α激动作用降低甘油三酯水平并增加高密度脂蛋白胆固醇(HDL-C)水平。因此,当合并时,这些药物可有效降低非HDL-C水平。尽管如此,很少有临床试验专门针对非HDL-C,以及三联疗法的疗效,包括他汀类药物,ezetimibe,和贝特类药物,尚未确定。
■这是一个多中心,prospective,随机化,开放标签,主动比较对照试验,涉及3,958名合格的T2D参与者,心血管危险因素,和升高的非HDL-C(≥100mg/dL)。参与者,已经在中等强度他汀类药物上,将被随机分配给Ezefeno(依泽替米贝/非诺贝特)添加或他汀类药物剂量递增。主要终点是48个月以上主要不良心血管和糖尿病微血管事件的复合发展。
■本试验旨在评估是否联合他汀类药物,ezetimibe,和非诺贝特一样有效,或者可能优于,他汀类药物单药治疗强化降低T2D患者心血管和微血管疾病风险.这可能提出一种新的治疗方法来管理T2D中的血脂异常。
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
This is a multicenter, prospective, randomized, open-label, active-comparator controlled
trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
This
trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.