Abstract: TH-PO224
Representation of Real-World Adults with CKD in Clinical Trials Supporting Blood Pressure Treatment Targets
Session Information
- Hypertension and CVD: Clinical - I
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Hypertension and CVD
- 1602 Hypertension and CVD: Clinical
Authors
- Li, June, VA Palo Alto Geriatric Research Education and Clinical Center, Palo Alto, California, United States
- An, Jaejin, Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, California, United States
- Huang, Mengjiao, VA Palo Alto Geriatric Research Education and Clinical Center, Palo Alto, California, United States
- Zhou, Matt Mengnan, Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, California, United States
- Montez-Rath, Maria E., Stanford University School of Medicine, Stanford, California, United States
- Niu, Fang, Kaiser Permanente Southern California, Pasadena, California, United States
- Sim, John J., Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, California, United States
- Pao, Alan C., Stanford University School of Medicine, Stanford, California, United States
- Charu, Vivek, Stanford University School of Medicine, Stanford, California, United States
- Odden, Michelle, VA Palo Alto Geriatric Research Education and Clinical Center, Palo Alto, California, United States
- Tamura, Manjula, VA Palo Alto Geriatric Research Education and Clinical Center, Palo Alto, California, United States
Background
Little is known about how well trial participants with 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.
Methods
We identified two real-world population of patients with CKD who met the guideline definition of hypertension based on use of antihypertensive medications or a sustained systolic BP ≥120 mm Hg in 2019 in the Veterans Health Administration (VA) and Kaiser Permanente of Southern California (KPSC). We applied the inclusion and exclusion criteria from 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, to estimate the proportion of adults with a systolic BP above the guideline recommended target of <120 mm Hg and the proportion who met eligibility criteria for ≥1 trial.
Results
We identified 503,480 adults in VA and 73,412 adults in KPSC with CKD and hypertension in 2019. We estimated 79.7% in the VA population and 87.3% in the KPSC population had a systolic BP ≥120 mm Hg; only 23.8% (95% CI: 23.7% - 24.0%) in the VA and 20.8% (95% CI: 20.5% - 21.1%) in KPSC were trial-eligible. BP trials were representative of <15% of adults with CKD and diabetes, age <50 years, or stage 4 CKD. More than 50% of trial-ineligible adults met ≥1exclusion criteria.
Conclusion
Fewer than one in four real-world adults with CKD and hypertension were represented in major BP target trials. A large proportion of adults who are at risk for cardiovascular morbidity from hypertension and susceptible to potential adverse treatment effects still lack relevant treatment information.
Percentage of real-world adults who meet eligibility criteria of blood pressure trials in the VA and KPSC.
Funding
- NIDDK Support