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BACKGROUND: Hyperkalemia, defined as a serum potassium level >5 mEq/L that results from multiple mechanisms, is a serious medical condition that can lead to life-threatening arrhythmias and sudden cardiac death. The coexistence of cardiac and renal diseases (ie, cardiorenal syndrome) significantly increases the complexity of care, but its economic impact is not well-characterized in this understudied Medicaid managed care population with hyperkalemia. OBJECTIVE: To calculate the economic impact of hyperkalemia on patients with cardiorenal syndrome in a Medicaid managed care population in the United States using real-world data. METHODS: In this retrospective cohort study, we used a proprietary Medicaid managed care database from 1 southern state. The total study population included 3563 patients, including 973 patients with hyperkalemia and 2590 controls (without hyperkalemia), who were matched based on age, comorbidities, and Medicaid eligibility status and duration, during a 30-month period between 2013 and 2016. The inclusion criteria for the hyperkalemia cohort were age >18 years, Medicaid-only insurance status, coded cardiorenal diagnosis, and a claim for hyperkalemia during the study period. The cost was determined using paid claims data. RESULTS: The mean healthcare costs (medical and pharmacy per member per year [PMPY] for patients with hyperkalemia was higher than that for the control cohort without hyperkalemia ($56,002 vs $23,653, respectively). These cost differences were driven by medical costs accrued in the hyperkalemia and in the control cohorts ($49,648 and $18,399 PMPY, respectively). Two of the largest drivers of the medical cost variance were inpatient costs ($33,116 vs $10,629 PMPY for the hyperkalemia and control cohorts, respectively) and dialysis costs ($2716 vs $810 PMPY, respectively). The medical loss ratios were 552% for the hyperkalemia cohort and 260% for the control cohort. Both cohorts had revenue deficits to the health plan, but the hyperkalemia cohort had double the medical loss ratio compared with the control cohort. CONCLUSIONS: The findings from this Medicaid managed care population suggest that hyperkalemia increases healthcare utilization and costs, which were primarily driven by the costs associated with inpa-tient care and dialysis. Our findings demonstrate that the Medicaid beneficiaries who have cardiorenal comorbidities accrue high costs to the Medicaid health plan, and these costs are even higher if a hyper-kalemia diagnosis is present. The very high medical loss ratio for the hyperkalemia cohort in our analysis indicates that enhanced monitoring and management of patients with hyperkalemia should be considered. [ABSTRACT FROM AUTHOR]

Background: Patiromer (PAT) is a sodium-free, non-absorbed potassium (K+) binder approved for the treatment of hyperkalemia (HK). HK is common in older patients (pts) with cardiorenal comorbidities and often limits the use of guideline recommended renin-angiotensin-aldosterone system inhibitor (RAASi) medications. We previously reported the design and results for AMETHYST-DN, a phase 2 multicenter, open-label, 52 week randomized clinical trial in a large cohort of adult pts (n=306; 30-80 years of age). Methods: Here we report the results in a subgroup ≥75 years of age with type 2 DM, chronic kidney disease (CKD) (eGFR 15 to <60 mL/min/1.73 m2), hypertension and serum (s) K+ >5.0 mEq/L (n=60). All pts received a RAASi before and during the study treatment and PAT was titrated to maintain sK+ in the normal range. Results: Two days after the first dose, mean sK+ was reduced to 4.89 mEq/L from a baseline (BL) mean of 5.19 mEq/L (p<0.001). The least square mean reduction in sK+ from BL to week 4 was -0.65 mEq/L (p<0.001) and -0.61 mEq/L (p<0.001) at 52 weeks (end of treatment). The % of pts with sK+ in the normal range (3.8-5.0 mEq/L) between weeks 12-52 ranged from 88-98%. At the end of treatment, 92% of pts had sK+ in the normal range. The most common GI-related adverse event (AE) was constipation observed in 2 pts (3.3%). Serum magnesium levels of <1.2 mg/dL were seen in 3 pts (5%). Hypokalemia (sK+ <3.5 mEq/L) did not occur in this older population. Serious AEs were reported for 9 pts (15%); none attributed to PAT by investigator. Study limitations include a lack of blinding, a lack of comparator, and a lack of diversity. Conclusions: In this subgroup of pts ≥75 years with diabetic CKD receiving a RAASi medication, PAT reduced and maintained control of sK+ for up to 1 year. PAT was well tolerated over 52 weeks with no serious AEs attributed to its use. These results suggest that PAT may facilitate the use of RAASi medications in older pts likely to benefit from their cardiorenal protective effects. Disclosure: G.L. Bakris: Consultant; Self; Merck & Co., Inc., Novo Nordisk Inc., Relypsa, Inc. Research Support; Self; Bayer AG, Janssen Pharmaceuticals, Inc. S.D. Woods: Employee; Self; Relypsa, Inc. P.J. Alvarez: Employee; Self; Relypsa, Inc. J. Fogli: Employee; Self; Relypsa, Inc. S. Arthur: Employee; Self; Relypsa, Inc. M.R. Mayo: Employee; Self; Relypsa, Inc. R. Kumar: None. Funding: Relypsa, Inc. [ABSTRACT FROM AUTHOR]

Hyperkalemia is common among elderly patients and is associated with an increase in morbidity and mortality. Patients at highest risk for developing hyperkalemia are those with chronic kidney disease (CKD) and heart failure (HF), particularly those on guideline-recommended inhibitors of the renin-angiotensin-aldosterone system (RAAS). Hyperkalemia remains a challenge for clinicians practicing in the long-term care setting as they are often faced with the difficult decision of down-titrating or discontinuing RAAS inhibitors in response to hyperkalemia in the very patients who derive the greatest benefit from these agents. In the past, options to chronically manage hyperkalemia were limited. Patiromer was approved for the treatment of hyperkalemia in 2015 and has been shown to maintain normokalemia for up to 52 weeks in patients with CKD and/or HF on RAAS inhibitors. With the emergence of a new hyperkalemia treatment, there could be a paradigm shift away from the discontinuation of guideline recommended therapies, allowing the continuation of RAAS inhibitor therapy to effectively manage HF symptoms and reduce the risk of rehospitalization in patients with HF, and slow the progression to end-stage renal disease in patients with CKD.