SAN FRANCISCO — Treatment with dapagliflozin may limit the rise in urinary albumin excretion in patients with type 2 diabetes. In a predefined analysis of DECLARE-TIMI 58 (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events; ClinicalTrials.gov Identifier: NCT01730534) presented at the American Diabetes Association 79th Scientific Sessions, held June 7 to 11, 2019 in San Francisco, California, the sodium-glucose cotransporter 2 inhibitor was associated with possible improvement of established albuminuria.
Previous studies have reported that dapagliflozin may improve renal parameters. In this analysis, the investigators assessed the effects of adding dapagliflozin to the standard treatment of albuminuria in a broad population of patients with type 2 diabetes with multiple cardiovascular (CV) risk factors or established atherosclerotic CV disease. The results were analyzed according to the patients’ baseline albuminuria status.
The study enrolled 17,160 patients with type 2 diabetes, including 10,186 with multiple CV risk factors (59%) and 6974 patients with atherosclerotic CV disease. The participants were randomly assigned to receive dapagliflozin 10 mg or placebo added to their standard treatment. The investigators examined the change in urinary albumin-to-creatinine ratio (UACR) over a median follow-up of 4 years with dapagliflozin compared with placebo.
Of the study participants, most (11,644 patients; 69%) had normoalbuminuria (UACR <30 mg/g), approximately one-fourth (4030 patients; 24%) had microalbuminuria (UACR ≥30 to ≤300 mg/g), and a minority (1169 patients; 7%) had macroalbuminuria (UACR >300 mg/g).
Treatment with dapagliflozin was associated with a smaller increase in UACR over time (-29.0 mg/g; 95% CI, -44.0 to -14.0; P =.0002). The effect of dapagliflozin was evident in patients with normoalbuminuria (-3.2 mg/g; 95% CI, -6.4 to 0.03; P =.052), microalbuminuria (-51.3 mg/g; 95% CI, -67.6 to -35.1; P <.0001) and macroalbuminuria (-262.3 mg/g; 95% CI -480.7 to -43.9; P =.019).
Treatment with dapagliflozin was also associated with significantly increased likelihood for improvement from microalbuminuria to normoalbuminuria (hazard ratio [HR], 1.35; 95% CI, 1.24-1.47; P <.0001) and from macroalbuminuria to microalbuminuria or normoalbuminuria (HR, 1.55; 95% CI, 1.34-1.80; P <.0001). Furthermore, dapagliflozin decreased the likelihood that patients deteriorated from normoalbuminuria to microalbuminuria or macroalbuminuria (HR, 0.84; 95% CI, 0.79-0.89; P <.0001).
“In a broad population of patients with [type 2 diabetes], long-term treatment with dapagliflozin blunts the rise in urinary albumin excretion, in all stratum of baseline albuminuria,” concluded the researchers.
Disclosures: AstraZeneca, which manufactures dapagliflozin, funded DECLARE-TIMI 58. Multiple authors disclosed associations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Raz I, Wiviott SD, Yanuv I, et al. Effects of dapagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes: a predefined analysis from the DECLARE-TIMI 58 randomised, placebo-controlled trial. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; Los Angeles, CA. Oral Presentation 244-OR.