Background Steroidal mineralocorticoid receptor antagonists (MRAs) are recommended for the treatment of heart failure (HF) and resistant hypertension, both common comorbidities in patients with diabetes and chronic kidney disease (CKD). This study explored the clinical characteristics of, and steroidal MRA use in, patients with CKD with and without type 2 diabetes mellitus (T2D) and/or HF. Methods This retrospective cohort study used PharMetrics Plus US claims database data (October 2009–September 2014) to identify two patient populations aged ≥18 years with a first diagnosis of CKD or a first prescription for steroidal MRAs. Demographic characteristics, comorbidities, clinical events, medication use and healthcare costs were reported by population and stratified by diagnosis: CKD, CKD + T2D (DKD), CKD + HF and DKD + HF. The CKD population cohorts were further stratified by steroidal MRA treatment duration (no MRAs, < 6 and ≥ 6 months’ treatment). Results The CKD and MRA populations comprised 229,004 patients and 5899 patients, respectively. Median age and the proportion of men were similar in the CKD and MRA populations across disease cohorts. Disease burden increased across the cohorts as comorbidity and clinical event incidences increased. Hypertension was reported in 70–92% of patients, irrespective of disease cohort or population. In the CKD population, MRA use was low but increased with disease burden: CKD, 1.2%; DKD, 1.8%; CKD + HF, 6.5%; and DKD + HF, 6.6%. Moreover, MRA users presented with higher rates of comorbidities and medication use, and higher healthcare costs than MRA non-users. Longer MRA treatment duration was associated with reduced polypharmacy, lower event rates and lower healthcare costs. In the MRA population, patients almost exclusively received spironolactone (≥ 96%; median dose across all groups 25 mg; one-year persistence, ≤ 43%); up to 16% of patients had end-stage renal disease at baseline despite steroidal MRAs being contraindicated. Conclusions Steroidal MRA use was low across all cohorts, but increased with disease severity, driven particularly by HF. Steroidal MRAs were used in patients with advanced CKD, despite being contraindicated. The persistent morbidity and clinical event rates in CKD and DKD patients highlight the disease burden and the need for treatments that effectively target both cardio-vascular and kidney-related events. Electronic supplementary material The online version of this article (10.1186/s12882-019-1348-4) contains supplementary material, which is available to authorized users.

Background Limited evidence has indicated that addition of a steroidal mineralocorticoid receptor antagonist (MRA) to the standard of care reduces proteinuria in patients with diabetic kidney disease (DKD); however, there are limited data regarding real-world MRA use in these patients. This study aimed to describe the characteristics of spironolactone users and non-users with DKD, and to explore their clinical outcomes. Methods This was a non-interventional, retrospective cohort study using demographic and clinical data from a US claims database (PharMetrics Plus) and the Experian consumer data asset during 2006–2015. Baseline characteristics (e.g. comorbidities) and post-inclusion clinical outcomes were described in matched cohorts of spironolactone users and non-users (n = 5465 per group). Results Although matching aligned key demographic and clinical characteristics of the cohorts, a significantly greater proportion of spironolactone users than non-users had oedema, proteinuria, and cardiovascular disease at baseline (P < 0.0001). During the post-inclusion period, disease progression and clinical events of interest such as acute kidney injury were more commonly observed in spironolactone users than non-users. Users also had higher healthcare resource utilization and costs than non-users; however, these differences diminished at later stages of disease. Conclusions In this study, spironolactone users had a greater comorbidity burden at baseline than matched non-users, suggesting that the presence of certain comorbidities may be contributing factors in the decision to prescribe spironolactone. High healthcare resource utilization and costs for patients at later stages of disease, irrespective of spironolactone use, highlight the need for new therapies for DKD.

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