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Combination of dapagliflozin and metformin ) at the start of a 2-week run-in phase followed by maintenance therapy of either dapagliflozin or metformin for 3 months until clinical response is achieved. The primary outcome was total mortality or serious adverse events. RESULTS: There were 804 patients enrolled in the trial (n=633 treatment arm, n=602 placebo n=511 received no treatment). Adverse events were assessed in 657 patients the dapagliflozin arm and 535 in the metformin arm as well in 439 patients the control arm. Treatment arm-relative risks (RR) were 1.14 (95%CI 0.88-1.48, p=0.10), 1.06 0.75-1.52, p=0.72), and 0.95 (95%CI 0.61-1.43, p=0.65) for patients with total mortality, nonfatal myocardial infarction (heart attack), and coronary heart disease event, respectively (RR=1.09; 95%CI 0.99-1.17, p=0.16;RR<1.00, p=0.92). Secondary outcomes included cardiac mortality, coronary death, cardiac-related deaths, myocardial infarction events, and hospitalization for arrhythmia or chest pain during the trial; RR for myocardial infarction events were 1.06 (95%CI 0.87-1.29, p=0.17), 1.05 0.79-1.42, p=0.85), and 0.89 (95%CI 0.71-1.12, p=0.51;RR<1.00, p=0.95), for total mortality, cardiac death, coronary cardiovascular-related deaths, and hospitalization for arrhythmia or chest pain. CONCLUSIONS: A combination of dapagliflozin and metformin improves the safety clinical effectiveness of an intensive antihypertensive treatment in patients primary care. Further investigation is required to determine whether this combination is clinically feasible and whether it results in better glycemic control.

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