Abstract

Abstract Background Empagliflozin (EMPA) reduced the risk of hospitalization for heart failure (HHF) (HR 0.65; 95% CI 0.50- 0.85) as demonstrated in the EMPA-REG OUTCOME trial in adults with type 2 diabetes (T2D) and established CV disease. However, the impact of EMPA treatment initiation on healthcare resource utilization (HCRU) in routine care in patients with history of heart failure (HF) or without history of HF remains unexplored. Purpose To compare HCRU among EMPA and dipeptidyl peptidase-4 inhibitor (DPP4i) initiators with and without HF history at time of treatment initiation. Methods We analyzed HCRU in the first two years after marketing of EMPA as part of EMPRISE, a non-interventional study on the comparative effectiveness, safety and HCRU of EMPA for T2D patients in routine care in two US commercial and Medicare claims datasets (08/2014–09/2016). We identified a 1:1 propensity-score-matched cohort of T2D patients ≥18 years initiating either EMPA or a DPP4i with and without baseline HF, and assessed the balance at baseline (period of 365 days) on ≥140 covariates including clinical, HCRU, and cost-related covariates using absolute standardized differences. We compared the risk of first all-cause hospitalization, risk of first HHF, risk of first emergency department (ED) visit, hospital length of stay (LOS), HF-related LOS, number of hospital admissions, HF-related hospital admissions, office visits, and ED visits in EMPA and DDP4i initiators. Results After propensity score matching, we identified 2,050 pairs with HF and 15,428 pairs without HF in the three datasets with mean follow-up of 5.2 and 5.4 months, respectively. All baseline characteristics were well balanced (with aSD<0.1). Compared to patients without HF history, patients with HF were older (65 vs 58), more commonly female (51% vs 46%), and had CV history (64% vs 19%) (Table 1). Compared to DPP4i, the hazard ratio (HR) for first hospitalization was 0.68 (95% CI: 0.56, 0.83) for EMPA initiators with HF, and 0.89 (95% CI: 0.80, 1.00) for initiators without HF. Risk of HF-related hospitalization and ED visit was lower in EMPA initiators with prior HF [HR=0.53 (0.38, 0.74) and HR=0.73 (0.58, 0.93), respectively] and without prior HF [HR=0.45 (0.27, 0.73) and HR=0.82 (0.70, 0.95), respectively]. Compared to DPP4i initiators, EMPA initiators with and without baseline HF had lower number of all hospital admissions [Incidence rate ratio (IRR)= 0.59 (0.50, 0.70) and IRR= 0.78 (0.71, 0.85), respectively] and HF-related hospital admissions [IRR=0.49 (0.37, 0.65) and IRR=0.34 (0.22, 0.53), respectively]. In-hospital days and HF-related in-hospital days per member per year (PMPY) in patients with and without HF history initiating EMPA were lower than DDP4i (Table 1). Conclusions Results observed in this interim analysis of EMPRISE showed reduction in overall HCRU as well as HF-related HCRU in both patients with and without heart failure (HF) initiating EMPA compared to DDP4i initiators. Acknowledgement/Funding This study was supported by a research grant to the Brigham and Women's Hospital from Boehringer-Ingelheim.

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