Representation of Real-World Adults With Chronic Kidney Disease in Clinical Trials Supporting Blood Pressure Treatment Targets

• Published in: Journal of the American Heart Association Vol. 13; no. 7; p. e031742
• Main Authors: Li, June, An, Jaejin, Huang, Mengjiao, Zhou, Mengnan, Montez-Rath, Maria E, Niu, Fang, Sim, John J, Pao, Alan C, Charu, Vivek, Odden, Michelle C, Kurella Tamura, Manjula
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 02.04.2024; Wiley
• Subjects: Adult; Antihypertensive Agents - pharmacology; Antihypertensive Agents - therapeutic use; Blood Pressure; blood pressure guidelines; chronic kidney disease; clinical trials; Clinical Trials as Topic; Cross-Sectional Studies; Humans; hypertension; Hypertension - diagnosis; Hypertension - drug therapy; Hypertension - epidemiology; Original Research; Renal Insufficiency, Chronic - diagnosis; Renal Insufficiency, Chronic - drug therapy; Renal Insufficiency, Chronic - epidemiology; blood pressure guidelines; chronic kidney disease; clinical trials; hypertension
• ISSN: 2047-9980; 2047-9980
• DOI: 10.1161/JAHA.123.031742

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.