Data were pooled from four trials (Table 1) which included patients with T2D and high risk for cardiovascular events (EMPA-REG OUT-COME), patients with HF, with or without diabetes (EMPEROR-Reduced and EMPEROR-Preserved), and a broad population of patients with CKD, with or without diabetes (EMPA-KID-NEY). In EMPA-REG OUTCOME, patients were randomized to receive empagliflozin 10 mg or 25 mg or placebo in addition to standard of care. In the other three trials, only the 10 mg dose of empagliflozin was investigated. To avoid a potential indication-associated bias, this pooled analysis was restricted to empagliflozin 10 mg. Furthermore, since the safety profiles of empagliflozin 10 mg and 25 mg have already been shown to be similar in the EMPA-REG OUTCOME trial, as well as in the latest pooled safety analysis of empagliflozin [6, 14] , inclusion of the 25 mg dose was not expected to add relevant further information to the analyses of the 10 mg dose. Therefore, only patients receiving empagliflozin 10 mg were included in the meta-analysis. In addition, patients with type 1 diabetes (10 patients from EMPEROR-Preserved and 68 patients from EMPA-KIDNEY) were excluded from the analyses to reflect the current indication.
The ethics committee at each center approved the trials, and all patients provided written informed consent. All original trials were performed in accordance with the Declaration of Helsinki.
The ethics committee at each center approved the trials, and all patients provided written informed consent. All original trials were performed in accordance with the Declaration of Helsinki.
