Dapagliflozin reduced the risk for hospitalization for any cause in patients with chronic kidney disease (CKD) regardless of whether they had type 2 diabetes, an industry-funded study found.
The study was a post hoc analysis of the DAPA-CKD trial, which randomized patients to the sodium-glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin versus placebo to determine the effects on first hospitalizations and all hospitalizations. The study included 4,304 adults with CKD (an estimated glomerular filtration rate [eGFR] of 25 to 75 mL/min/1.73 m2 and a urinary albumin-creatinine ratio of 200 to 5,000 mg/g) with and without type 2 diabetes from 386 outpatient facilities in 21 countries from February 2017 through June 2020. The study was funded by AstraZeneca. Results were published Dec. 6 in Annals of Internal Medicine.
A total of 1,224 (28.4%) patients had at least one hospitalization during follow-up, 808 (18.8%) had at least one hospitalization that was prolonged or ended in death, and 453 (10.5%) had two or more hospitalizations. In the dapagliflozin group, 566 (26.3%) patients had at least one hospitalization, for an event rate of 143.7 per 1,000 person-years; in the placebo group, 658 (30.6%) patients had at least one hospitalization, for an event rate of 171.9 events per 1,000 person-years. The hazard ratio (HR) for a first hospitalization with dapagliflozin was 0.84 (95% CI, 0.75 to 0.94). Dapagliflozin also reduced the risk for a prolonged hospitalization or one ending in death (HR, 0.83; 95% CI, 0.72 to 0.95), the composite of first hospitalization or death (HR, 0.83; 95% CI, 0.75 to 0.93), or all hospitalizations or death (rate ratio [RR], 0.79; 95% CI, 0.70 to 0.89) compared with placebo.
The researchers found no evidence that the effects of dapagliflozin on first and all hospitalizations varied by presence of type 2 diabetes at baseline (P=0.60 for the interaction for each). Dapagliflozin reduced the rate of admissions due to cardiac disorders, renal and urinary disorders, metabolism and nutrition disorders, and neoplasms versus placebo.
According to the study authors, these findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR slope, and albuminuria. They noted that the post hoc analysis should be viewed as hypothesis-generating.
“Hospitalization contributes to the burden of CKD and reduces health-related quality of life. Moreover, hospitalization in the CKD population results in an enormous expenditure of resources around the world,” the authors wrote. “Hospitalization of patients with CKD not requiring dialysis accounts for a large proportion of Medicare and non-Medicare health care expenditures. A reduction in hospitalization of even half the magnitude of what was reported in the DAPA-CKD trial would be expected to significantly reduce health care expenditures in the United States and elsewhere.”