Study outcomes
sudden cardiac death, arteriosclerosis obliterans, arteriosclerosis, TG
SUDDEN CARDIAC DEATH, ACUTE MYOCARDIAL INFARCTION, CEREBROVASCULAR DISORDERS, PERIPHERAL ARTERIAL DISEASE, ISCHEMIC HEART DISEASE, INTRACEREBRAL HEMORRHAGE, ADVERSE EVENTS, UNSTABLE ANGINA, ARTERIOSCLEROSIS OBLITERANS, SUBARACHNOID HEMORRHAGE, ARTERIOSCLEROSIS, EVENTS, CEREBRAL INFARCTION
The primary endpoints in this extension study were the changes in the mean and maximum carotid intima-media thickness of the common carotid artery (IMT-CCA) measured by carotid arterial echography from the baseline (week 0) in the main study to week 208. In particular, the change in the mean of the right and left mean IMT-CCA from baseline to week 208 was considered the most important endpoint in this study. Secondary endpoints included changes in biomarkers of glycemic control (HbA1c and fasting blood glucose), lipids (total cholesterol (TC), HDL-C, TG, and low-density lipoprotein cholesterol (LDL-C)), renal function (serum creatinine, urinary albumin excretion (UAE), and eGFR), and arteriosclerosis and cardiovascular risks (brachial-ankle pulse wave velocity (baPWV) and ankle-brachial index (ABI)), the frequency of cardiovascular events including ischemic heart disease (sudden cardiac death, acute myocardial infarction, unstable angina, and undergoing coronary revascularization), cerebrovascular disorders (cerebral infarction, intracerebral hemorrhage, and subarachnoid hemorrhage), and peripheral arterial disease (arteriosclerosis obliterans and leg amputation), and the frequency of adverse events.