2 型糖尿病的强化与标准血压控制：随机对照试验的受限平均生存时间分析,BMJ Open

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2 型糖尿病的强化与标准血压控制：随机对照试验的受限平均生存时间分析
BMJ Open ( IF 2.4 ) Pub Date : 2021-09-01 , DOI: 10.1136/bmjopen-2021-050335
Sandra Shi ₁ , Natalia Gouskova ₁ , Mehdi Najafzadeh ₂ , Lee-Jen Wei ₃ , Dae Hyun Kim _{2,

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Affiliation

背景与 HR 相比，受限平均生存时间分析提供了对治疗效果的直观且可靠的总结。目的检查强化与标准血压 (BP) 控制对 2 型糖尿病患者死亡或心血管事件的影响。设计糖尿病血压试验中控制心血管风险行动的二次分析。在美国和加拿大设置 77 个站点。参与者 4733 名患有心血管事件高风险的 2 型糖尿病成人。干预措施收缩压目标 <120 mm Hg (n=2371) 与 <140 mm Hg (n=2362)。测量死亡、非致命性心肌梗塞或非致命性中风的复合终点。结果强化血压控制和标准血压控制之间 5 年（1825 天）的平均无事件生存时间相似（1716 天对 1714 天；平均差异为 1.3（95% CI -18）。1 到 20.7) 天）。然而，强化血压治疗对那些被分配到标准血糖控制的患者更有益（1725 天 vs 1697 天；平均差异，28.1（95% CI 0.4 到 55.9）天），但对那些被分配到强化血糖控制（1706 天 vs 1731 天）的患者无效；平均差异，-25.2（95% CI -52.3 至 1.9）天）（交互作用 p=0.008）。在亚组分析中，强化和标准 BP 治疗之间的平均无事件生存时间差异对于认知障碍患者为 -76.0（95% CI –131.8 至 –20.3）天，对于认知障碍患者为 21.8（95% CI –24.0 至 67.5）天那些具有正常认知功能的人（交互p=0.008）。效果在年龄、性别和基线心血管疾病状态方面没有差异。结论强化血压治疗可减少接受标准血糖治疗且无认知障碍的 2 型糖尿病患者的死亡和心血管事件。试验注册号[NCT00000620][1]；后结果。数据在公共、开放存取的存储库中可用。本手稿是使用从国家健康肺和血液研究所 (NHLBI) 生物标本和数据存储信息协调中心获得的 ACCORD 研究材料编写的，不一定反映 ACCORD 或 NHLBI 的意见或观点。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00000620&atom=%2Fbmjopen%2F11%2F9%2Fe050335.atom 开放存取存储库。本手稿是使用从国家健康肺和血液研究所 (NHLBI) 生物样本和数据存储信息协调中心获得的 ACCORD 研究材料编写的，不一定反映 ACCORD 或 NHLBI 的意见或观点。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00000620&atom=%2Fbmjopen%2F11%2F9%2Fe050335.atom 开放存取存储库。本手稿是使用从国家健康肺和血液研究所 (NHLBI) 生物样本和数据存储信息协调中心获得的 ACCORD 研究材料编写的，不一定反映 ACCORD 或 NHLBI 的意见或观点。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00000620&atom=%2Fbmjopen%2F11%2F9%2Fe050335.atom

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Intensive versus standard blood pressure control in type 2 diabetes: a restricted mean survival time analysis of a randomised controlled trial

Background Restricted mean survival time analysis offers an intuitive and robust summary of treatment effect compared with HRs. Objective To examine the effect of intensive versus standard blood pressure (BP) control on death or cardiovascular events in type 2 diabetes. Design Secondary analysis of the Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial. Setting 77 sites in the USA and Canada. Participants 4733 adults with type 2 diabetes at high risk for cardiovascular events. Interventions Systolic BP target <120 mm Hg (n=2371) versus <140 mm Hg (n=2362). Measurements Composite endpoint of death, non-fatal myocardial infarction or non-fatal stroke. Results The mean event-free survival time over 5 years (1825 days) was similar between intensive and standard BP control (1716 vs 1714 days; mean difference, 1.3 (95% CI −18.1 to 20.7) days). However, intensive BP treatment was more beneficial for those assigned to standard glycaemic control (1725 vs 1697 days; mean difference, 28.1 (95% CI 0.4 to 55.9) days), but not for those assigned to intensive glycaemic control (1706 vs 1731 days; mean difference, −25.2 (95% CI −52.3 to 1.9) days) (p=0.008 for interaction). In subgroup analysis, the mean event-free survival time difference between intensive and standard BP treatment was −76.0 (95% CI –131.8 to –20.3) days for those with cognitive impairment and 21.8 (95% CI −24.0 to 67.5) days for those with normal cognitive function (p=0.008 for interaction). The effect was not different by age, sex and baseline cardiovascular disease status. Conclusions Intensive BP treatment may reduce death and cardiovascular events among patients with type 2 diabetes receiving standard glycaemic treatment and without cognitive impairment. Trial registration number [NCT00000620][1]; Post-results. Data are available in a public, open access repository. This manuscript was prepared using ACCORD Research Materials obtained from the National Health Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center and does not necessarily reflect the opinions or views of the ACCORD or the NHLBI. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00000620&atom=%2Fbmjopen%2F11%2F9%2Fe050335.atom

更新日期：2021-09-13

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