| Title: |
Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care ; A First Analysis From the EMPRISE Study |
| Authors: |
Patorno, Elisabetta; Pawar, Ajinkya; Franklin, Jessica M.; Najafzadeh, Mehdi; Déruaz-Luyet, Anouk; Brodovicz, Kimberly G.; Sambevski, Steven; Bessette, Lily G.; Santiago Ortiz, Adrian J.; Kulldorff, Martin; Schneeweiss, Sebastian |
| Source: |
Circulation ; volume 139, issue 25, page 2822-2830 ; ISSN 0009-7322 1524-4539 |
| Publisher Information: |
Ovid Technologies (Wolters Kluwer Health) |
| Publication Year: |
2019 |
| Description: |
Background: The EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 diabetes Mellitus Patients) showed that empagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces the risk of hospitalization for heart failure (HHF) by 35%, on top of standard of care in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The EMPRISE (Empagliflozin Comparative Effectiveness and Safety) study aims to assess empagliflozin’s effectiveness, safety, and healthcare utilization in routine care from August 2014 through September 2019. In this first interim analysis, we investigated the risk of HHF among T2D patients initiating empagliflozin versus sitagliptin, a dipeptidyl peptidase-4 inhibitor. Methods: Within 2 commercial and 1 federal (Medicare) claims data sources in the United States, we identified a 1:1 propensity score–matched cohort of T2D patients ≥18 years old initiating empagliflozin or sitagliptin from August 2014 through September 2016. The HHF outcome was defined as a HF discharge diagnosis in the primary position (HHF-specific); a broader definition was based on a HF discharge diagnosis in any position (HHF-broad). Hazard ratios (HRs) and 95% CIs were estimated controlling for over 140 baseline characteristics in each data source and pooled by fixed-effects meta-analysis. Results: After propensity-score matching, we identified 16,443 patient pairs who initiated empagliflozin or sitagliptin. Average age was approximately 59 years, almost 54% of the participants were males, and approximately 25% had records of existing cardiovascular disease. Compared with sitagliptin, the initiation of empagliflozin decreased the risk of HHF-specific by 50% (HR, 0.50; 95% CI, 0.28–0.91), and the risk of HHF-broad by 49% (HR, 0.51;95% CI, 0.39–0.68), over a mean follow-up of 5.3 months. The results were consistent in patients with and without baseline cardiovascular disease, and for empagliflozin at both the 10- and 25-mg daily doses; analyses comparing empagliflozin ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1161/circulationaha.118.039177 |
| DOI: |
10.1161/CIRCULATIONAHA.118.039177 |
| Availability: |
https://doi.org/10.1161/circulationaha.118.039177; https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.118.039177 |
| Accession Number: |
edsbas.CDFF462 |
| Database: |
BASE |