Abstract
BackgroundLimited 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.MethodsThis 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).ResultsAlthough 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.ConclusionsIn 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.
Highlights
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); there are limited data regarding real-world MR antagonists (MRAs) use in these patients
Results from a few small clinical trials have suggested that addition of an MRA to the standard of care in patients with mild-to-moderate chronic kidney disease (CKD) with or without diabetes may further reduce proteinuria; there is an increased risk of hyperkalaemia
In a previous observational study, we identified that real-world MRA use was low (1.2%) in patients with CKD; use increased with greater disease burden to 1.8% in those with DKD and 6.6% in those with DKD and heart failure
Summary
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); there are limited data regarding real-world MRA use in these patients. Results from a few small clinical trials have suggested that addition of an MRA to the standard of care in patients with mild-to-moderate chronic kidney disease (CKD) with or without diabetes may further reduce proteinuria; there is an increased risk of hyperkalaemia. It is not known whether MRA therapy reduces the risk of ESRD or cardiovascular events in these patients [21,22,23]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
