1_糖尿病患者CVD_评估和治疗危险性的争论.pptVIP

糖尿病患者CVD 评估和治疗危险性的争论 研究后监测: 患者 研究结束后 A1C改变 心肌梗死危险比(致死或非致死性心梗或猝死) 早期血糖控制的遗留效应 研究后监测: 患者 研究结束后血压的改变 早期BP控制没有遗留效应 RECORD罗格列酮对糖尿病患者心血管后果与血糖调控的评估 RECORD 研究设计 血糖控制目标与补救治疗  血糖控制目标 A1C ≤7.0% 补救治疗 标准: 确认 A1C ≥8.5% 罗格列酮联合治疗 第一步 – 强化至三药 (罗格列酮 + 二甲双胍 + 磺脲类) 第二步 – 停用罗格列酮，开始使用胰岛素 (± 继续二甲双胍/磺脲类) 磺脲类+ 二甲双胍联合治疗 开始胰岛素 (± 继续二甲双胍/磺脲类) 平均 A1C (%) 随时间的变化 主要后果 RECORD 时间点 招募: 2001年4月 –2003年4月 最后一次回访: 2008年8月–12月 平均随访时间: 5.5 年 随访 罗格列酮组, 12,338 患者-年 磺脲类和二甲双胍组, 12,272 患者-年 主要终点失访: 7.2% 患者-年 根据2007 CV 争论, 额外32名患者停药 (1.4%) 基线时特征 CV入院或 CV 死亡 次要终点 基线及5年时CV 治疗 平均体重 (kg)随时间变化 基线时代谢参数 5年内血脂平均变化 全部低血糖不良事件* 严重不良事件 – 恶性肿瘤 骨折类型 按性别分层的骨折 Key Points Here we can see the mean A1C levels from baseline to 5 years in RECORD trial participants. Note the changes in both groups. Key Points Primary outcomes in the RECORD trial were either time to first CV hospitalization or CV death. CV hospitalization included: myocardial infarction, heart failure, stroke, unstable angina, transient ischemic attack, unplanned CV revascularization, amputation of extremities, or any other definite CV reason. CV death included: myocardial infarction, heart failure, stroke, sudden death, other acute vascular events, other CV mortality, or death of unknown cause. Key Points The RECORD timeline was as follows: Recruitment: April 2001 to April 2003 Last visits: August 2008 to December 2008 Mean follow-up: 5.5 years Follow-up included: rosiglitazone group: 12,338 patient-years sulfonylurea and metformin group: 12,272 patient-years Loss to follow-up for primary endpoint: 7.2% patient-years Following concerns raised about CV effects in 2007, there was excess discontinuation from rosiglitazone (32 patients, 1.4%) Key Point This slide depicts the cumulative incidence of CV hospitalization and CV death rates over 6 years, in patients taking either rosiglitazone (321 events) or metformin/sulfonylurea (323 events). Key Point Again, using data gathered from the RECORD trial patient population, and using sensitivity analyses,