Milicevic Zvonko, Raz Itamar, Strojek Krzysztof, Skrha Jan, Tan Meng H, Wyatt John W, Beattie Scott D, Robbins David C
Eli Lilly and Company, Vienna, Austria.
J Diabetes Complications. 2005 Mar-Apr;19(2):80-7. doi: 10.1016/j.jdiacomp.2004.06.003.
Cardiovascular (CV) disease is the major cause of death in patients with diabetes. Up to 40% of patients with Type 2 diabetes mellitus (T2DM) who survive an initial myocardial infarction (MI) suffer a recurrent event within 2 years, the majority of which are fatal. One independent risk factor for cardiovascular disease (CVD) may be postprandial blood glucose (PPBG) excursions. The HEART2D study seeks to determine the effect that PPBG control has on cardiovascular outcomes in patients who suffered an MI within the 21 days before study enrollment.
Approximately 1355 patients with T2DM with recent MI will be entered in this multicenter study of about 3.0-year duration. Using infarct severity and peri-infarct treatment as randomization factors, patients will be assigned to one of two insulin treatment strategies: (1) postprandial strategy: premeal insulin lispro with basal insulin at bedtime if needed (NPH insulin), targeting 2-h PPBG < or = 7.5 mmol/l or (2) basal strategy: insulin (NPH insulin twice daily or insulin glargine once daily; or premixed human insulin (70% NPH/30% regular; 30/70) twice daily), targeting fasting and premeal blood glucose (BG; < or = 6.7 mmol/l). Both groups will aim for a target hemoglobin AlC (AlC) of < 7%.
The anticipated difference in PPBG (approximately 2.0 to 2.5 mM) between strategies is expected to demonstrate a 15% to 18.5% relative risk reduction in CV events for the postprandial strategy.
This study may provide practical insights into the clinical management of patients with diabetes who have an increased risk of recurrent CV events and death.
心血管（CV）疾病是糖尿病患者的主要死因。在初次心肌梗死（MI）后存活的2型糖尿病（T2DM）患者中，高达40%会在2年内发生复发事件，其中大多数是致命的。餐后血糖（PPBG）波动可能是心血管疾病（CVD）的一个独立危险因素。HEART2D研究旨在确定PPBG控制对在研究入组前21天内发生MI的患者心血管结局的影响。
约1355例近期发生MI的T2DM患者将参与这项为期约3.0年的多中心研究。以梗死严重程度和梗死周围治疗作为随机因素，患者将被分配到两种胰岛素治疗策略之一：（1）餐后策略：必要时（中性鱼精蛋白锌胰岛素）在睡前使用基础胰岛素赖脯胰岛素，目标是2小时PPBG≤7.5 mmol/L；或（2）基础策略：胰岛素（每日两次中性鱼精蛋白锌胰岛素或每日一次甘精胰岛素；或每日两次预混人胰岛素（70%中性鱼精蛋白锌胰岛素/30%正规胰岛素；30/70）），目标是空腹和餐前血糖（BG；≤6.7 mmol/L）。两组的目标糖化血红蛋白A1C（A1C）均<7%。
两种策略之间预期的PPBG差异（约2.0至2.5 mM）预计将显示餐后策略的心血管事件相对风险降低15%至18.5%。
本研究可能为复发CV事件和死亡风险增加的糖尿病患者的临床管理提供实际见解。
