[医药卫生]ASCOT研究--降压降脂随机、对照、析因研究.ppt

ASCOT- BPLA: Rationale Insufficient outcome data on newer types of BP-lowering agents, especially in specific combination treatment regimens Less-than-expected CHD prevention using standard therapy ASCOT- BPLA Additional objectives include: Secondary end points Total stroke All coronary events Primary end point minus silent MI Total cardiovascular (CV) events and procedures CV mortality All-cause mortality Heart failure Tertiary end points Development of diabetes Impairment of renal function Pre-specified end points in pre-specified subgroups Life-threatening arrhythmias Other objectives Interaction between statins and antihypertensive treatment Health economic analyses Study design Patient inclusion criteria Screening and baseline BP ? 160/100 mm Hg untreated ? 140/90 mm Hg following treatment with 1 or more drugs Age 40-79 years No previous MI or current clinical CHD 3 or more CV risk factors Study power and recruitment (Feb 1998-May 2000) Baseline characteristics Data safety monitoring board (DSMB) Statistical methods Based on an intention-to-treat analysis Time to first primary event Log-rank procedure and Cox’s Proportional Hazards were used to calculate confidence intervals Cumulative incidence curves were generated using the Kaplan-Meier method ASCOT patient population risk factor profile trial design 血压变化 Mean proportion of time on antihypertensive medication by treatment group 主要终点: 非致死性 MI, 致死性 CHD Endpoints: Non-fatal MI (excl silent) + fatal CHD 总的冠脉终点 致死和非致死性卒中 总的心血管事件及操作 CV 死亡率 全因死亡率 Fatal and non-fatal heart failure 不稳定型心绞痛 慢性稳定型心绞痛 外周血管疾病 恶性心律失常 新发肾功能不全 新发糖尿病 CV 死亡 + MI + 卒中 所有终点的结果 Adverse events leading to treatment discontinuation Adverse events ASCOT Committees Executive and Writing Committee B Dahl?f, Co-Chairman, Gothenburg, P Sever, Co-Chairman, London, N Poulter, Secretary, London, H Wedel, Statistician, Gothenburg. Steering Committee A Adderkin, London, DG Beevers, Birmingham, J Buch, New York (non-voting), M Caulfiel