790-P: Empagliflozin Reduced the Total Burden of Events Leading to or Prolonging Hospitalization in EMPA-REG OUTCOME

Abstract

Background: In EMPA-REG OUTCOME, empagliflozin (EMPA) reduced the risk of all-cause mortality (ACM) and total (first plus recurrent) events leading to all-cause hospitalization in patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD). We assessed the effect of EMPA on the total burden of events leading to or prolonging all-cause hospitalization (ACPH) as well as the composite of ACPH and ACM.Methods: Patients were randomized to EMPA 10 mg, 25 mg, or placebo. Post hoc, we assessed the effect of pooled EMPA vs. placebo on total events of ACPH, as reported by investigators, and an ACPH/ACM composite, using a negative binomial model.Results: Among 7,020 patients, there were 5,256 ACPH events (5,031 leading to and 225 prolonging hospitalization) and 5,617 ACPH/ACM events. EMPA reduced the risk of total events of ACPH by 22% vs. placebo (rate ratio [95% CI]: 0.78 [0.70, 0.87]) and ACPH/ACM by 24% vs. placebo (0.76 [0.69, 0.85]) (Figure). The number of ACPH/ACM events prevented with EMPA vs. placebo was 67.7 per 1000 patient years; the number needed to treat (NNT) (95% CI) over the three years of the trial to prevent one event was 4.9 (3.5, 8.4).Conclusions: EMPA showed a sizeable reduction in the total burden of mortality and events leading to or prolonging hospitalization in patients with T2D and ASCVD, with a clinically relevant number of events prevented and a low NNT.View largeDownload slideView largeDownload slide DisclosureS. E. Inzucchi: Consultant; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Esperion, Merck & Co., Inc., Novo Nordisk. C. Wanner: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Consultant; Self; Bayer AG, Boehringer Ingelheim International GmbH, Speaker’s Bureau; Self; Eli Lilly and Company. D. H. Fitchett: None. B. Zinman: Advisory Panel; Self; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi. S. Anker: Consultant; Self; Abbott, Bayer AG, Boehringer Ingelheim International GmbH, Cardiac Dimensions Pty. Ltd., Impulse Dynamics, Novartis AG, Servier Laboratories, Vifor Pharma Management Ltd., Other Relationship; Self; Abbott, Vifor Pharma Management Ltd. M. Mattheus: Employee; Self; Boehringer Ingelheim Pharma GmbH & Co. KG. O. Vedin: Employee; Self; Boehringer Ingelheim International GmbH. S. Hantel: Employee; Self; Boehringer Ingelheim Pharma GmbH & Co. KG. S. S. Lund: Employee; Self; Boehringer Ingelheim International GmbH, Other Relationship; Self; No specific name - possibly multiple companies, Stock/Shareholder; Self; Novo Nordisk A/S.