An analysis of the REVOLUTIONIZE II study data showed that there is an unmet need for long-term outpatient treatment of hyperkalemia in patients with CKD.
Results from the observational REVOLUTIONIZE II study showed that patients with stage 3b/4 chronic kidney disease (CKD) had significantly higher rates of major adverse cardiovascular events (MACE), MACE or inpatientadmission with heart failure (MACE+), and inpatient arrhythmia if they also had hyperkalemia vs if they did not have hyperkalemia, according to the authors of a poster presented at the American Society of Nephrology’s (ASN) 2023 Kidney Week Annual Meeting. The authors noted that these data help to clarify that there is an unmet need for long-term outpatient treatment of hyperkalemia in this patient population.
“Patients may not be aware of the risks of hyperkalemia that exist before they reach kidney failure,” said Mike Spigler, vice president of Patient Services and Kidney Disease Education at the American Kidney Fund, in an interview with Pharmacy Times. “Through its Beyond Bananas campaign, American Kidney Fund is working to educate patients that anyone with advancing kidney disease is at risk for hyperkalemia and, as a result, cardiovascular problems.”
A common complication of moderate to advanced chronic kidney disease, hyperkalemia can have a significant impact on cardiovascular outcomes. However, the exact impact of hyperkalemia (defined as serum K+ >5.0 mEq and diagnosis code in any setting) on the time to cardiovascular outcomes among patients with CKD has not been thoroughly investigated. To address this issue, the authors analyzed cardiovascular outcomes in the REVOLUTIONIZE II study.
Using the de-identified Market Clarity database, the analysis of the data focused on propensity score matched adult patients with stage 3b/4 chronic kidney disease, with or without hyperkalemia (hyperkalemia and non-hyperkalemia cohorts). During the analysis, the index dates for the hyperkalemia cohort were the first CKD stage 3b/4 diagnosis date after 1 or more hyperkalemia diagnosis in the 12 months prior, and for the non-hyperkalemia cohort, the date was a randomly selected CKD stage 3b/4 diagnosis date. The cardiovascular outcomes were analyzed in 3 matched subsets and included MACE (ie, all-cause mortality or inpatient admission with myocardial infarction or stroke), MACE+, and inpatient admission with arrhythmia.
Among the total 6619 matched pairs, the cardiovascular analysis subsets included 5949 pairs for MACE, 5301 for MACE+, and 5564 for inpatient arrhythmia. The investigators balanced the baseline variables between the 2 cohorts in all subsets (hyperkalemia and non-hyperkalemia cohorts). In each subset, the data showed that the hyperkalemia cohort had significantly higher rates of cardiovascular outcomes than the non-hyperkalemia cohort at follow-up (P<0.001 for each cardiovascular subset).
“Because this is an observational study, it is possible that unmeasured factors could be the cause of the worse cardiovascular outcomes in patients with hyperkalemia,” said Jamie Green, MD, MS, chair of the American Kidney Fund's Medical Affairs Committee, nephrologist with Geisinger Health System, and co-director of the Kidney Health Research Institute, in an interview with Pharmacy Times. “More studies are needed to determine the true risk of hyperkalemia and whether treatment of hyperkalemia can improve outcomes.”
Agiro A, Coman E, Greatsinger A, et al. Association Between Hyperkalemia and Cardiovascular Outcomes in Patients with Stage 3b/4 CKD: REVOLUTIONIZE II Study. Presented at: 2023 ASN/Kidney Week. November 2, 2023. Accessed November 2, 2023. https://www.asn-online.org/education/kidneyweek/2023/program-abstract.aspx?controlId=3939172