Upper gastrointestinal (GI) erosions were the most common non-cardiovascular events observed in a study of patients receiving dialysis in the United States, according to data presented at the National Kidney Foundation’s 2023 Spring Clinical Meetings in Austin, Texas.
The data are from a retrospective observational study of patients enrolled in Medicare Advantage plans who were undergoing hemodialysis or peritoneal dialysis. Investigators divided patients into a treatment-eligible cohort (eligible for anemia treatment; 1897 patients) and a clinical trial-like cohort (approximating eligibility criteria for the ASCEND-D trial of daprodustat as a treatment for anemia in patients on dialysis; 357 patients). The median follow-up for the cohorts was 2.25 and 2.16 years, respectively.
In the treatment-eligible and clinical trial-like cohorts, 1102 and 208 patients, respectively, experienced esophageal and gastric erosions, Julie Rouette, PhD, of Value Evidence and Outcomes, GSK in Montreal, Canada, and colleagues reported in a poster presentation. The rates of these upper GI erosions were 48.66 and 51.86 per 100 patient-years, respectively.
During follow-up, malignancies were diagnosed in 282 and 48 patients in the treatment-eligible and clinical trial-like cohorts, respectively. The event rates were 7.96 and 7.42 per 100 patient-years, respectively. Solid cancers were the most commonly diagnosed malignancies. The investigators acknowledged that the follow-up duration was relatively short for these events to be observed.
These findings help provide context for non-cardiovascular events in the chronic dialysis population in the United States, the authors concluded.
Among other inclusion criteria, the ASCEND-D trial required patients to have CKD stages 3-5, hemoglobin levels of 8-10 g/dL at randomization, and no erythropoiesis-stimulating agent (ESA) use within the 6 weeks prior to trial screening and no ESA use between screening and randomization.
Disclosure: GSK funded the study. All study authors are employees of, and/or hold stock or shares in GSK.
Rouette J, Mu G, Ma L, Wetten S. Background rates of selected non-cardiovascular (non-CV) events of interest in dialysis-dependent (DD) patients in the United States (US). Presented at: NKF 2023, Austin, Texas, April 11-15. Poster 248.