Department of Epidemiology and Population Health Stanford University School of Medicine Stanford CA USA.
Geriatric Research and Education Clinical Center VA Palo Alto Health Care Systems Palo Alto CA USA.
J Am Heart Assoc. 2024 Apr 2;13(7):e031742. doi: 10.1161/JAHA.123.031742. Epub 2024 Mar 27.
Little is known about how well trial participants with chronic kidney disease (CKD) represent real-world adults with CKD. We assessed the population representativeness of clinical trials supporting the 2021 Kidney Disease: Improving Global Outcomes blood pressure (BP) guidelines in real-world adults with CKD.
Using a cross-sectional analysis, we identified patients with CKD who met the guideline definition of hypertension based on use of antihypertensive medications or sustained systolic BP ≥120 mm Hg in 2019 in the Veterans Affairs and Kaiser Permanente of Southern California. We applied the eligibility criteria from 3 BP target trials, SPRINT (Systolic Pressure Intervention Trial), ACCORD (Action to Control Cardiovascular Risk in Diabetes), and AASK (African American Study of Kidney Disease), to estimate the proportion of adults with a systolic BP above the guideline-recommended target and the proportion who met eligibility criteria for ≥1 trial. We identified 503 480 adults in the Veterans Affairs and 73 412 adults in Kaiser Permanente of Southern California with CKD and hypertension in 2019. We estimated 79.7% in the Veterans Affairs and 87.3% in the Kaiser Permanente of Southern California populations had a systolic BP ≥120 mm Hg; only 23.8% [23.7%-24.0%] in the Veterans Affairs and 20.8% [20.5%-21.1%] in Kaiser Permanente of Southern California were trial-eligible. Among trial-ineligible patients, >50% met >1 exclusion criteria.
Major BP target trials were representative of fewer than 1 in 4 real-world adults with CKD and hypertension. A large proportion of adults who are at risk for cardiovascular morbidity from hypertension and susceptible to adverse treatment effects lack relevant treatment information.
对于患有慢性肾脏病（CKD）的试验参与者在多大程度上代表了真实世界中患有 CKD 的成年人，我们知之甚少。我们评估了支持 2021 年肾脏病：改善全球预后（KDIGO）血压（BP）指南的临床试验在真实世界中患有 CKD 的成年人中的人群代表性。
使用横断面分析，我们根据 2019 年退伍军人事务部和南加州凯撒 Permanente 中使用抗高血压药物或持续收缩压≥120mmHg 的情况，确定了符合指南定义的高血压的 CKD 患者。我们应用了 3 项 BP 目标试验，即 SPRINT（收缩压干预试验）、ACCORD（控制糖尿病心血管风险行动）和 AASK（非裔美国人肾脏病研究）的入选标准，以估计收缩压高于指南推荐目标的成年人比例和符合≥1 项试验入选标准的成年人比例。我们在退伍军人事务部中确定了 503480 名患有 CKD 和高血压的成年人，在南加州凯撒 Permanente 中确定了 73412 名患有 CKD 和高血压的成年人。我们估计退伍军人事务部中有 79.7%的人收缩压≥120mmHg，南加州凯撒 Permanente 中有 87.3%的人收缩压≥120mmHg；退伍军人事务部中只有 23.8%[23.7%-24.0%]和南加州凯撒 Permanente 中只有 20.8%[20.5%-21.1%]符合试验入选标准。在不符合试验入选标准的患者中，超过 50%的患者符合超过 1 项排除标准。
主要的 BP 目标试验仅代表不到 1/4 的真实世界中患有 CKD 和高血压的成年人。很大一部分患有高血压导致心血管发病率风险和易受不良治疗效果影响的成年人缺乏相关的治疗信息。
