Empagliflozin Reduces the Total Burden of All-cause Hospitalisations and All-cause Mortality in the EMPA-REG OUTCOME trial

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

Methods Participants were randomised to empagliflozin 10 mg, empagliflozin 25 mg, or placebo. We assessed the effect of pooled empagliflozin versus placebo on total events of a composite of ACH or ACM using a negative binomial model.

Results Among 7,020 participants (mean [SD] age 63 [9] years), there were 5,399 total events of ACH and ACM. The most frequent hospitalisations were cardiac disorders (1,339), infections and infestations (841), and nervous system disorders (511); ACM: n=463. Empagliflozin reduced the risk of total events of ACH or ACM by 19% versus placebo (event rate ratio [95% CI]: 0.81 [0.74, 0.88], p < 0.0001); ACH alone 0.83 (0.76, 0.91), ACM alone 0.69 (0.57, 0.83). Across most hospitalisation categories, a numerically smaller proportion of participants experienced events with empagliflozin versus placebo. The estimated number of total ACH or ACM events prevented with empagliflozin was 793.3; number of patients needed to treat (NNT) over 3 years to prevent one event was 5.4 (3.8, 9.3).

Conclusion Empagliflozin reduced risk of the total burden of ACH and mortality in patients with T2D and established atherosclerotic CV disease, with a clinically relevant number of events prevented and a low NNT.

Publication History

Article published online:
06 May 2021