Treatment Lowers Diabetes Rate in Patients With Kidney Disease, Heart Failure
In patients with chronic kidney disease and heart failure, dapagliflozin treatment reduced the incidence of new-onset type 2 diabetes without lowering HbA1C, according to study results published online ahead of print in The Lancet Diabetes & Endocrinology.
“Chronic kidney disease and heart failure are insulin-resistant states associated with a high incidence of diabetes,” wrote an international team of researchers. “We assessed the effect of dapagliflozin on new-onset type 2 diabetes in a pooled analysis of patient-level data from the DAPA-CKD and DAPA-HF trials.”
The clinical trials were phase 3, double-blind, randomized, and placebo-controlled studies. The pooled analysis included a total 4003 participants: 1398 were from DAPA-CKD and 2605 were from DAPA-HF. At baseline, participants included in the pooled analysis had no history of diabetes, with HbA1c levels less than less than 6.5%. About half of the participants in pooled analysis received dapagliflozin, and the other half received placebo.
“Over a median follow-up of 21.2 months (IQR 16.0-25.4), 126 (6.3%) of 2008 patients in the placebo group (event rate 3.9 per 100 patient-years) and 85 (4.3%) of 1995 patients in the dapagliflozin group (event rate 2.6 per 100 patient-years) developed type 2 diabetes (hazard ratio 0.67 [95% CI .51-.88]; P=.0040),” researchers reported.
The effect of dapagliflozin appeared consistent across subgroups, including sex, age, glycemic status, body mass index, glomerular filtration rate, systolic blood pressure, and baseline cardiovascular medication use, the study found. Among participants who did develop type 2 diabetes, 9 out of 10 had prediabetes at baseline.
The average HbA1c did not change. Researchers reported a placebo-adjusted difference in the dapagliflozin group of -0.01% and -0.1 mmol/mol at 12 months.
AstraZeneca funded the study.
Reference:
Rossing P, Inzucchi SE, Vart P, et al. Dapagliflozin and new-onset type 2 diabetes in patients with chronic kidney disease or heart failure: pooled analysis of the DAPA-CKD and DAPA-HF trials. Lancet Diabetes Endocrinol. 2021;44(2):586-594. doi:10.2337/dc20-1675