e Learned from the Failure of Large Clinical Trials 事与愿违.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 Post-trial Study UKPDS (UK Protective Diabetes Study) Type-2 DM: low plasma glucose, Reduction in microvascular complications. Whether the therapy can reduce macrovascular complications? 降糖治疗试验停止后，持续随访10年的结果 Holman et al NEJM 2008:359: Any DM-related Endpoints： sudden death， death from hyperglycemia, hypoglycemia, fatal, non-fatal MI, angina, heart failure, fatal, non-fatal Stroke, renal failure, amputation, vitreous hemorrhage, retinal photo-coagulation, blindness in one eye, hyperglycemia, Hypoglycemia. Microvascular disease: vitreous (玻璃体)hemorrhage, retinal photo-Coagulation(视网膜光凝术 ), renal failure,