背景:非诺贝特对糖尿病和他汀类药物治疗患者动脉粥样硬化性心血管疾病(ASCVD)结局的有益作用尚不清楚。我们调查了非诺贝特对糖尿病患者全因死亡率和ASCVD的影响,高甘油三酯(TG)水平和他汀类药物治疗。
方法:我们使用韩国国家健康信息数据库2010年至2017年的数据进行了一项全国倾向评分匹配(1:1)队列研究。该研究包括110,723名糖尿病患者,TG水平≥150mg/dL,并且没有使用他汀类药物和非诺贝特的ASCVD的先前诊断,和相同数量的仅使用他汀类药物的相似患者(对照组)。研究结果包括新诊断的心肌梗死(MI),中风,两者(MI和/或中风),和全因死亡率。
结果:在平均4.03年的随访期内,与对照组相比,非诺贝特组的结局风险比(HR)为0.878[95%置信区间(CI)0.827-0.933],卒中0.901(95%CI0.848-0.957),心梗和/或卒中的0.897(95%CI0.858-0.937),全因死亡为0.716(95%CI0.685-0.749)。非诺贝特的这些有益作用在TG150-199mg/dL的亚组中一致,但根据低密度脂蛋白胆固醇(LDL-C)水平而有所不同。
结论:在这项全国性的倾向评分匹配队列研究中,涉及糖尿病患者和TG≥150mg/dL,非诺贝特联合他汀类药物治疗的全因死亡和ASCVD风险显著低于单用他汀类药物治疗.然而,这一发现仅对LDL-C水平相对较高的个体有意义.
BACKGROUND: The beneficial effects of
fenofibrate on atherosclerotic cardiovascular disease (ASCVD) outcomes in patients with diabetes and statin treatment are unclear. We investigated the effects of
fenofibrate on all-cause mortality and ASCVD in patients with diabetes, high triglyceride (TG) levels and statin treatment.
METHODS: We performed a nationwide propensity-score matched (1:1) cohort study using data from the National Health Information Database in the Republic of Korea from 2010 to 2017. The study included 110,723 individuals with diabetes, TG levels ≥ 150 mg/dL, and no prior diagnoses of ASCVD who used statins and
fenofibrate, and an equal matched number of similar patients who used statins alone (control group). The study outcomes included newly diagnosed myocardial infarction (MI), stroke, both (MI and/or stroke), and all-cause mortality.
RESULTS: Over a mean 4.03-year follow-up period, the hazard ratios (HR) for outcomes in the
fenofibrate group in comparison to the control group were 0.878 [95% confidence interval (CI) 0.827-0.933] for MI, 0.901 (95% CI 0.848-0.957) for stroke, 0.897 (95% CI 0.858-0.937) for MI and/or stroke, and 0.716 (95% CI 0.685-0.749) for all-cause death. These beneficial effects of
fenofibrate were consistent in the subgroup with TG 150-199 mg/dL but differed according to low-density lipoprotein cholesterol (LDL-C) levels.
CONCLUSIONS: In this nationwide propensity-score matched cohort study involving individuals with diabetes and TG ≥ 150 mg/dL, the risk of all-cause death and ASCVD was significantly lower with fenofibrate use in conjunction with statin treatment compared to statin treatment alone. However, this finding was significant only in individuals with relatively high LDL-C levels.