Cardiovascular
Outcomes of Real-world Adults with Chronic Kidney Disease Who Are Excluded from Hypertension Clinical Trials June Li* June Li Maria E. Montez-Rath Mengjiao Huang Vivek Charu Jaejin An Michelle C. Odden John J. Sim Manjula Kurella Tamura
Background – Real-world adults with chronic kidney disease (CKD) are not well represented in major blood pressure (BP) target trials. Uncertainty remains around the efficacy and safety of intensifying treatment in excluded populations with different clinical characteristics. We assessed whether clinical outcomes differed between trial eligible and ineligible adults with CKD.
Methods – In a retrospective cohort study, we identified patients with CKD and hypertension in the Veterans Health Administration (VA) in 2019 who were eligible for at least one of three BP target trials, the Systolic Pressure Intervention Trial, the Action to Control Cardiovascular Risk in Diabetes trial, and the African American Study of Kidney Disease. We examined the association between trial eligibility and outcomes of death, major cardiovascular events (MACE), serious adverse events (SAEs), and end stage kidney disease (ESKD). Follow-up was censored at death, end of database linkage, or September 30, 2022. We ascertained the incidence rates, RDs, and HRs using cause-specific analysis for competing risk of death.
Results – We identified 120,038 trial eligible and 383,442 trial ineligible adults with CKD and hypertension in 2019. Trial ineligible adults had a moderately elevated risk of death (HR, 1.88, 95% CI, 1.85–1.91), MACE (HR, 1.90, 95% CI, 1.88–1.92), and SAEs (HR, 1.63, 95% CI, 1.61–1.65), and a markedly elevated risk of ESKD (HR, 4.39, 95% CI, 4.18–4.62) compared to trial eligible adults. The corresponding absolute risk differences were largest for death, MACE and kidney related SAEs, and smallest for ESKD.
Conclusion – Trial ineligible adults with CKD and hypertension had higher relative and absolute risks for all outcomes compared to trial eligible adults, but the pattern of risk differed by outcome, suggesting that the benefit-risk profile of hypertension treatment may differ from that of CKD patients included in trials.
