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.
Keywords: Diabetic kidney disease; End-stage renal disease; Mineralocorticoid receptor antagonist; Real-world evidence; Spironolactone.