Trial results for dapagliflozin in patients with an acute heart attack were posted on ClinicalTrials.gov on 2025-03-07. The Phase 3 study (NCT04564742) demonstrated that dapagliflozin achieved a win ratio of 1.34 (95% CI: 1.2 to 1.5; p=0.001) compared to placebo for a hierarchical composite endpoint of cardiometabolic outcomes.
Background
The study, titled "Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack," aimed to evaluate the impact of dapagliflozin on cardiometabolic outcomes, including hospitalization for heart failure (HHF) and cardiovascular (CV) death, in patients who had experienced a myocardial infarction (MI).
Trial design
The Phase 3 study (NCT04564742) was a randomized, placebo-controlled trial that enrolled 4017 participants. The study investigated dapagliflozin versus placebo, given once daily in addition to Standard of Care (SoC) therapies, in patients with acute myocardial infarction and heart failure. The primary objective was to determine if the clinical benefit of dapagliflozin was superior to placebo, utilizing a hierarchical composite endpoint and win-ratio method.
Key results
The primary analysis, based on the intention-to-treat principle using the Full Analysis Set, utilized a Win Ratio (WR) method for the hierarchical primary composite endpoint. The results demonstrated that dapagliflozin achieved a Win Ratio of 1.34 (95.0% CI: 1.2 to 1.5) compared to placebo, with a p-value of 0.001. This indicates a statistically significant superior clinical benefit for dapagliflozin.
The study enrolled 1990 participants in the dapagliflozin 10 mg group and 1970 participants in the placebo group for the full analysis set.
What this means
The statistically significant Win Ratio of 1.34 for dapagliflozin versus placebo suggests a superior clinical benefit for patients with acute myocardial infarction regarding cardiometabolic outcomes. These findings indicate that dapagliflozin, when added to standard of care, could improve outcomes such as hospitalization for heart failure and cardiovascular death in this high-risk patient population. This data may inform future treatment guidelines and clinical practice for managing post-MI patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04564742, titled "Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack," were posted on 2025-03-07 on clinicaltrials.gov.