Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Division of General Medicine, University of Michigan, Ann Arbor, Michigan; Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.
J Am Coll Cardiol. 2018 Sep 11;72(11):1214-1223. doi: 10.1016/j.jacc.2018.07.012.
Controversy over blood pressure (BP) treatment targets for individuals with diabetes is in part due to conflicting perspectives about generalizability of available trial data.
The authors sought to estimate how results from the largest clinical trial of intensive BP treatment among adults with diabetes would generalize to the U.S.
The authors used transportability methods to reweight individual patient data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) BP trial (N = 4,507) of intensive (goal systolic BP <120 mm Hg) versus standard (goal systolic BP <140 mm Hg) treatment to better represent the demographic and clinical risk factors of the U.S. population of adults with diabetes (data from NHANES [National Health and Nutrition Examination Survey] 2005 to 2014, n = 1,943). The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Analysis used weighted Cox proportional hazards regression models with robust standard errors.
The ACCORD BP sample had less racial/ethnic diversity and more elevated cardiovascular risk factors than the NHANES participants. Weighted results significantly favored intensive BP treatment, unlike unweighted results (hazard ratio for primary outcome in intensive versus standard treatment in weighted analyses: 0.67, 95% confidence interval: 0.49 to 0.91; in unweighted analyses: hazard ratio: 0.88, 95% confidence interval: 0.73 to 1.07). Over 5 years, the weighted results estimate a number needed to treat of 34, and number needed to harm of 55.
After reweighting to better reflect the U.S. adult population with diabetes, intensive BP therapy was associated with significantly lower risk for cardiovascular events. However, data were limited among racial/ethnic minorities and those with lower cardiovascular risk.
针对糖尿病患者的血压（BP）治疗目标存在争议，部分原因是对现有试验数据的普遍性存在不同看法。
作者试图估计在糖尿病成人中进行强化 BP 治疗的最大临床试验结果在多大程度上适用于美国。
作者使用可传递性方法，对来自 ACCORD（控制心血管风险行动中的糖尿病）BP 试验（N=4507 例）的个体患者数据进行重新加权，该试验比较了强化（目标收缩压<120mmHg）与标准（目标收缩压<140mmHg）治疗，以更好地代表美国糖尿病成人人群的人口统计学和临床危险因素（数据来自 NHANES[国家健康和营养检查调查]2005 年至 2014 年，n=1943）。主要结局是首次发生非致死性心肌梗死、非致死性卒中和心血管死亡。分析采用加权 Cox 比例风险回归模型和稳健标准误差。
与 NHANES 参与者相比，ACCORD BP 样本的种族/民族多样性较少，心血管危险因素水平较高。与未加权结果不同，加权结果明显有利于强化 BP 治疗（加权分析中强化治疗与标准治疗的主要结局的危险比为 0.67，95%置信区间：0.49 至 0.91；未加权分析中为 0.88，95%置信区间：0.73 至 1.07）。在 5 年内，加权结果估计治疗需要数为 34，危害需要数为 55。
经过重新加权以更好地反映美国糖尿病成年人群后，强化 BP 治疗与心血管事件风险显著降低相关。然而，数据在少数民族和心血管风险较低的人群中有限。
