Aims: In EMPA-REG OUTCOME, empagliflozin (EMPA) reduced hospitalization for heart failure risk and cardiovascular (CV) mortality in patients (pts) with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD). We assessed the effect of EMPA on total (first and recurrent) events of ACH and all-cause mortality (ACM).

Methods: Pts were randomized to EMPA 10 mg, EMPA 25 mg, or placebo (PBO). We assessed the effect of EMPA pooled vs. PBO on total events of a composite of ACH or ACM using a negative binomial model.

Results: Among 7,020 pts (mean [SD] age 63 [9] years), there were 5,399 total events of ACH and ACM. The most frequent hospitalizations were cardiac disorders (1,339), infections and infestations (841), and nervous system disorders (511); ACM: n=463. EMPA reduced the risk of total events of ACH or ACM by 19% vs. PBO (event rate ratio (95% CI): 0.81 (0.74, 0.89), p<0.0001) (Figure); ACH alone 0.83 (0.76, 0.91), ACM alone 0.69 (0.57, 0.83). Across most hospitalization categories, a numerically smaller proportion of pts experienced events with EMPA vs. PBO. The estimated number of total ACH or ACM events prevented with EMPA was 793.3; number of pts needed to treat (NNT) over 3 years to prevent one event was 5.4 (3.8, 9.3).

Conclusion: EMPA reduced risk of the total burden of ACH and mortality in pts with T2D and ASCVD, with a clinically relevant number of events prevented and a low NNT.

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Disclosure

S.E. Inzucchi: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Abbott, Merck & Co., Inc., vTv Therapeutics. B. Zinman: Advisory Panel; Self; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. C. Wanner: Advisory Panel; Self; Eli Lilly and Company, Merck & Co., Inc., Mundipharma International. Consultant; Self; Boehringer Ingelheim (Canada) Ltd., Sanofi Genzyme. Speaker’s Bureau; Self; AstraZeneca. Other Relationship; Self; Boehringer Ingelheim International GmbH. D.H. Fitchett: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Lilly Diabetes. Other Relationship; Self; Novo Nordisk Inc. S. Anker: Research Support; Self; Abbott Laboratories, Vifor Pharma Group. Other Relationship; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Cardiac Dimension, Impulse Dynamics, Novartis AG, Respicardia, St. Jude Medical, Vifor Pharma Group. S. Pocock: Consultant; Self; Boehringer Ingelheim International GmbH. S. Kaspers: Employee; Self; Boehringer Ingelheim International GmbH. J.T. George: Employee; Self; Boehringer Ingelheim International GmbH. O. Johansen: Employee; Self; Boehringer Ingelheim International GmbH. W. Jamal: 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. Stock/Shareholder; Self; Novo Nordisk A/S. Other Relationship; Self; Investment funds.

Funding

Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance

© 2020 by the American Diabetes Association
2020
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