At the 2023 European Society of Cardiology (ESC) Congress, study results found that early initiation of Forxiga (dapagliflozin) failed to improve diuretic efficiency in hospitalized patients with acute decompensated heart failure (ADHF). Specifically, the DICTATE-AHF trial set out to evaluate whether early initiation of Forxiga within the first day of hospitalization could optimize guideline directed medical therapy (GDMT) and complete decongestion. This study could be of high clinical value to cardiologists looking to find an optimal treatment of choice for patients with acute HF. Failing to meet the primary endpoint in the DICTATE-AHF trial is a major setback for Forxiga which is being assessed for expanded approval to differentiate in HF space, says GlobalData, a leading data and analytics company.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments: “Many patients who present with acute HF either have a history of HF or have advanced HF that has suddenly decompensated. However, a proportion of acute HF hospitalizations are referred to as de novo acute HF episode—patients with no prior history of HF. Although it is easier to identify acute HF in a patient previously diagnosed with HF, it is still vital to determine the cause of the sudden decompensation of HF, as well as the severity of their condition.”

The DICTATE-AHF trial, which included 240 patients with type 2 diabetes, showed that after adjusting baseline weight, the odds ratio for diuretic efficiency with Forxiga versus usual structured care was 0.65, 95% confidence interval 0.41 to 1.01, p=0.06. In the unadjusted analysis, the odds ratio was 0.64, 95% confidence interval 0.41 to 1.00, p=0.05. Furthermore, Forxiga increased natriuresis and urine output while reducing the time it takes to finish IV diuretic therapy and hospital discharge.

Key opinion leaders interviewed by GlobalData emphasized that sodium-glucose cotransporter type 2 inhibitors are taking precedence over established older classes because they are effective, and physicians don’t have to be wary of major side effects when discharging patients from the hospital.

Jaddoo concludes: “Incidence of acute HF represents a huge financial burden on the global healthcare systems due to the resources and costs associated with hospitalization and the highly likely readmission of a patient. Therefore, developing an evidence-based therapy for the treatment of acute HF represents a huge opportunity.”