Link to Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure | NEJM Evidence
DAPA-MI is the first double-blind registry-based randomized controlled trial (R-RCT). This trial was conducted in Sweden and the United Kingdom and used the national clinical quality registries SWEDEHEART and MINAP and other innovative digital approaches to facilitate study conduct.
A total of 4017 patients with acute myocardial infarction, but no diabetes or chronic heart failure, were randomly assigned 10 mg of dapagliflozin or placebo. DAPA-MI demonstrated a significant benefit of treatment with dapagliflozin in terms of cardiometabolic outcomes as compared with placebo in patients without diabetes or chronic heart failure presenting with acute myocardial infarction and impaired left ventricular systolic function. Analyses using the win ratio method resulted in significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% confidence interval (CI), 1.20 to 1.50; P<0.001) when comparing the hierarchical composite of:
2. Hospitalization for heart failure
3. Non-fatal MI
4. Atrial fibrillation/flutter
5. Type 2 diabetes mellitus
6. NYHA Functional Classification at the last visit
7. Body weight decrease ≥5% at the last visit
The greater weight reduction, better functional class and lower incidence of new-onset diabetes were important contributors to the primary outcome. The clinical event rates were low with limited power for evaluation of individual or composite cardiovascular events, which occurred at similar rates in both groups.
The innovative registry-based clinical trial (R-RCT) design, incorporating national clinical registry data, facilitated efficient patient recruitment and outcome ascertainment. DAPA-MI was conducted in collaboration between the study sponsor AstraZeneca and Uppsala Clinical Research Center (UCR).
We want to thank all patients and the study personnel that made this trial possible!
Stefan James, International coordinating investigator, professor of Cardiology at Uppsala University and Scientific Director of UCR.
Jonas Oldgren, Chair, DAPA-MI Executive committee. Professor, Uppsala university and Senior Scientic Advisor, UCR.