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Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial

Waijer SW, Xie D, Inzucchi SE, Zinman B, Koitka-Weber A, Mattheus M, von Eynatten M, Inker LA et al.

Journal of the American Heart Association, 2020

12 participants · 77 citations

Abstract

Background Early reduction in albuminuria with an SGLT2 (sodium‐glucose cotransporter 2) inhibitor may be a positive indicator of long‐term cardiovascular and renal benefits. We assessed changes in albuminuria during the first 12 weeks of treatment and subsequent long‐term cardiovascular and renal risks associated with the SGLT2 inhibitor, empagliflozin, in the EMPA‐REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 diabetes Mellitus Patients) trial. Methods and Results We calculated the percentage urinary albumin creatinine ratio (UACR) change from baseline to week 12 in 6820 participants who did not experience a cardiovascular outcome (including 3‐point major cardiovascular events and cardiovascular death or hospitalization for heart failure) or renal outcome (defined as 40% decline in estimated glomerular filtration rate from baseline, estimated glomerular filtration rate 30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27–1.58; P <0.001). During 3.0 years of follow‐up, 704 major cardiovascular events, 440 cardiovascular deaths/hospitalizations for heart failure, and 168 renal outcomes were observed. Each 30% decrease in UACR during the first 12 weeks was statistically significantly associated with a lower hazard for major cardiovascular events (HR, 0.96; 95% CI, 0.93–0.99; P =0.012), cardiovascular deaths/hospitalizations for heart failure (HR, 0.94; 95% CI, 0.91–0.98; P =0.003), and renal outcomes (HR, 0.83; 95% CI, 0.78–0.89; P <0.001).…

How strong is the evidence?

Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.

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