Abstract

Introduction: Steroidal mineralocorticoid receptor antagonists (sMRA), spironolactone and eplerenone, are indicated for several cardiovascular (CV) conditions, including heart failure and hypertension. However, adverse drug reactions may lead to discontinuation. This study aimed to explore sMRA treatment patterns and predictors of discontinuation. Methods: This retrospective observational study used administrative claims from the Healthcare Integrated Research Database® to identify naïve adult users of sMRAs between 01 Jan 2016 and 31 May 2021 with at least 12 months of continuous health plan enrollment before initiation. Five subgroups were identified based on comorbidities before sMRA initiation - heart failure with preserved or reduced ejection fraction (HFpEF/HFrEF), undetermined heart failure (undHF), chronic kidney disease (CKD) and type 2 diabetes (T2D), and nondiabetic-CKD (ndCKD). sMRA treatment patterns and discontinuation (i.e., no refill within two prescription cycles) were described. Multivariate logistic regression modeling was used to explore predictors (i.e., demographics, comorbidity burden, specialist prescribing, CV disease, and medications) of discontinuation in all sMRA users and subgroups separately. Results: We identified 224,100 sMRAs users (99% spironolactone), including 8,553 HFpEF, 19,636 HFrEF, 20,336 undHF, 11,336 CKD and T2D, and 10,134 ndCKD, patients. Over a median of 655 days, a dose change was observed in 23% of patients. A dose increase was more common than a decrease (16% vs. 7%), a trend that was observed across all subgroups. Overall, 73% of sMRA users discontinued treatment after a median of 90 days. Discontinuation in subgroups was lower; 62% in HFpEF, 58% in HFrEF, 61% in undHF, and 66% in both CKD subgroups. No specific factors were consistently associated with increased odds of sMRA discontinuation. However, increased comorbidity burden, use of other CV medications, and cardiologist prescribers significantly decreased the odds of discontinuation across most subgroups. Conclusions: Most naïve sMRA users discontinue therapy within six months of initiation. No demographic or clinical factors were consistently associated with increased odds of sMRA discontinuation.

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