Add-on dapagliflozin of no help in critically ill patients with acute organ dysfunction

In the treatment of critically ill patients with acute organ dysfunction, use of the SGLT-2 inhibitor dapagliflozin in addition to standard care does not appear to improve clinical outcomes, according to a study.

The study included 507 participants (mean age 63.9 years, 46.9 percent women) with unplanned ICU admission and presenting with at least one organ dysfunction (respiratory, cardiovascular, or kidney). These patients were randomly assigned to receive either 10 mg of dapagliflozin plus standard care (intervention, n=248) or standard care alone (control, n=259). Treatment was given for up to 14 days or until ICU discharge, whichever came first.

The primary outcome was a hierarchical composite of hospital mortality, initiation of kidney replacement therapy (KRT), and ICU length of stay through 28 days, examined using the win ratio method. Secondary outcomes were hospital mortality, KRT use, ICU-free days, hospital-free days, vasopressor-free days, mechanical ventilation–free days, and KRT-free days—evaluated using Bayesian regression models.

Of the participants, 39.6 percent had an ICU admission due to suspected infection. The participants were enrolled in the study a median of one day after being admitted to the ICU. The win ratio for the primary composite outcome was 1.01 (95 percent confidence interval, 0.90–1.13; p=0.89), with no clear evidence of participants on dapagliflozin living longer, as well as avoiding KRT and being discharged sooner.

With regard to the secondary outcomes, the highest probability of benefit found was 0.90 for use of KRT, which was less frequent in the dapagliflozin group than in the control group (10.9 percent vs 15.1 percent).