Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease - The ADMIT Study: A randomized trial
Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease - The ADMIT Study: A randomized trial
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DOI：
10.1001/jama.284.10.1263
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发表时间：
2000-09-13
影响因子：
120.7
通讯作者：
Brinton, EA
中科院分区：
文献类型：
--
作者：
Elam, MB;Hunninghake, DB;Brinton, EA
背景：尽管烟酸会增加糖尿病患者的低水平高密度脂蛋白胆固醇(高密度脂蛋白胆固醇)，但目前的指南不建议糖尿病患者使用烟酸，因为担心对血糖控制的不利影响；目的确定烟酸调脂剂量对糖尿病患者的疗效和安全性。设计和设置于1993年8月至1995年12月在6个临床中心进行的前瞻性、随机、安慰剂对照临床试验。参与者共468人，包括125名糖尿病患者，已诊断为周围动脉疾病。经过一段积极的磨合期后，参与者被随机分配到服用烟酸(结晶烟酸)、3000 mg/d或最大耐受量(n=合并糖尿病；n=173合并糖尿病)或安慰剂(n=61合并糖尿病)。结果与安慰剂相比，服用烟酸的糖尿病患者和非糖尿病患者的血浆脂蛋白、血糖、血红蛋白A(1c)(HbA(1c))、丙氨酸氨基转移酶(ALT)和尿酸水平；降糖药物使用的依从性；以及不良事件。结果烟酸的使用显著增加了高密度脂蛋白胆固醇(HDLC)29%和29%，甘油三酯(TG)分别降低23%和28%，低密度脂蛋白胆固醇(LDL-C)分别降低8%和9%(P
Context Although niacin increases low levels of high-density lipoprotein cholesterol (HDL-C), which frequently accompany diabetes, current guidelines do not recommend use of niacin in patients with diabetes because of concerns about adverse effects on glycemic control; however, this is based on limited clinical data.Objective To determine the efficacy and safety of lipid-modifying dosages of niacin in patients with diabetes.Design and Setting Prospective, randomized placebo-controlled clinical trial conducted in 6 clinical centers from August 1993 to December 1995.Participants A total of 468 participants, including 125 with diabetes, who had diagnosed peripheral arterial disease.Interventions After an active run-in period, participants were randomly assigned to receive niacin (crystalline nicotinic acid), 3000 mg/d or maximum tolerated dosage (n = 64 with diabetes; n = 173 without diabetes), or placebo (n = 61 with diabetes; n = 170 without diabetes) for up to 60 weeks (12-week active run-in and 48-week double-blind).Main Outcome Measures Plasma lipoprotein, glucose, hemoglobin A(1c) (HbA(1c)), alanine aminotransferase, and uric acid levels; hypoglycemic drug use: compliance; and adverse events, in patients with diabetes vs without who were receiving niacin vs placebo.Results Niacin use significantly increased HDL-C by 29% and 29% and decreased triglycerides by 23% and 28% and low-density lipoprotein cholesterol (LDL-C) by 8% and 9%, respectively, in participants with and without diabetes (P