事与愿违的大型临床试验结果告诉了我们什麽PPT.ppt

What We have Learned from the Failure of Large Clinical Trials? 事与愿违的大型临床试验结果告诉了我们什麽? HUI Rutai 惠汝太 Beijing FuWai Hospital, China 北京阜外医院高血压中心主任 prioritizes target levels of some risk factors: plasma sugar blood presure cholestrol Womens Health Initiative RCT revealed that hormone-replacement therapy, which reduces LDL cholesterol levels, increased the risk of cardiovascular disease. (Anderson et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Womens Health Initiative Randomized Controlled Trial. JAMA 2004;291:1701-1712) ENHANCE ENHANCE: Effect of Combination Ezetimibe and High-Dose Simvastatin versus Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia Kastelein et al: NEJM 2008,358:1431-1443; Correction: NEJM 2008,358:1977 ENHANCE showed that ezetimibe did not reduce the progression of arteriosclerosis when combined with simvastatin, as compared with simvastatin alone, even though the combination did result in a greater reduction of LDL cholesterol. Kastelein et al: NEJM 2008,358:1431-1443; Correction: NEJM 2008,358:1977 Follow-up 10 years Sulfonylurea-Insulin Metoformin Any DM-related Endpoints 9% (P=0.04) 21% (P=0.01) Microvas Dis 24%(P=0.001) MI 15% (P=0.01) 33%(P=0.005) Death from Any cause 13%(P=0.007) 27% (P=0.002) 与传统限制饮食治疗比较，药物强化治疗 Holman et al NEJM 2008:359: ADVANCE The ADVANCE：action in diabetes and vascular disease -- preterax and diamicron MR controlled evaluation. Diabetologia 2001;44:1118-1120 Collaborative Group NEJM 2008, 358:2560-2572 ADVANCE 11,140 patients with type 2 diabetes ; Grouped: 1. standard glucose control 2. intensive gl