Study: Dapagliflozin Does Not Improve Outcomes in Hospitalized Patients With COVID-19
The primary endpoint of organ failure or death was 11.2% for those receiving dapagliflozin compared to 13.8% for those receiving the placebo.
New research has found that dapagliflozin (Farxiga) did not significantly reduce organ dysfunction or death among noncritically ill hospitalized patients with COVID-19. Furthermore, it did not improve recovery among these patients.
The DARE-19 trial aimed to assess the safety and efficacy of dapagliflozin among eligible hospitalized patients with COVID-19, according to research presented at the American College of Cardiology 2021 conference. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor commonly used for patients with type 2 diabetes, heart failure, and chronic kidney disease.
In the clinical trial, 1250 eligible patients were randomized 1:1 to receive either dapagliflozin 10 mg daily or a placebo. Participants were hospitalized with confirmed or suspected SARS-CoV-2 for 4 days or longer and had an oxygen saturation of 94% or greater on ≤5 L/min. They also hadat least 1 risk factor, such as hypertension, type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD), heart failure, or chronic kidney disease.
Exclusion criteria included type 1 diabetes, critical illness on presentation, an estimated glomerular filtration rate of less than 25 ml/min/1.73 m2, and prior diabetic ketoacidosis. According to the study, 51% of the participants had type 2 diabetes and 16% had ASCVD. The mean systolic blood pressure was 127 mm Hg.
According to the press release, the primary endpoint of organ failure or death was 11.2% for those receiving dapagliflozin compared to 13.8% for those administered the placebo. The secondary outcomes were composite kidney endpoint and all-cause mortality. The composite kidney endpoint was 7.7% among the dapagliflozin group and 10.4% among the placebo group, whereas the all-cause mortality rate was 6.6% and 6.8%, respectively.
Based on these results, the investigators said dapagliflozin did not significantly reduce organ dysfunction or death, or improve recovery among noncritically ill hospitalized patients with COVID-19. They also noted that adverse effects were similar across both the dapagliflozin and control arms.
Despite these discouraging findings, the authors said events of organ failure and death were numerically lower with dapagliflozin, especially for the composite kidney endpoint. Because of this, they said it is possible that a larger trial would have shown a benefit, although this needs to be proven. Future research would also need to find the exact mechanism of a potential benefit, because this is still unclear.
Dapagliflozin in Respiratory Failure in Patients With COVID-19 – DARE-19. News release. American College of Cardiology. May 16, 2021. Accessed May 18, 2021. https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2021/05/14/02/40/DARE-19.