In patients with type 2 diabetes at high cardiovascular risk, empagliflozin, a sodium-glucose cotransporter 2 inhibitor, may be associated with a slower progression of kidney disease and lower rates of renal events, according to a report from the EMPA-REG OUTCOME trial presented June 14 at the American Diabetes Association’s 76th Scientific Sessions in New Orleans and simultaneously published in the New England Journal of Medicine.

The trial assigned 7,020 patients at 590 sites in 42 countries to receive either empagliflozin (at a dose of 10 mg or 25 mg) or placebo once daily in addition to standard care. At baseline, the estimated glomerular filtration rate (eGFR) was 45 to 59 ml per minute per 1.73 m² in 17.8 percent of the patients and 30 to 44 ml per minute per 1.73 m² in 7.7 percent. Additionally, 28.7 percent had microalbuminuria and 11.0 percent had macroalbuminuria. More than 99 percent of patients had established cardiovascular disease.

Christoph Wanner, MD, and colleagues assessed the renal microvascular outcomes, and found that incident or worsening nephropathy occurred in 12.7 percent of patients in the empagliflozin group and 18.8 percent of the placebo group, a significant relative reduction of 39 percent. Progression to macroalbuminuria occurred in 11.2 percent of the empagliflozin group and 16.2 percent of the placebo group, a significant relative reduction of 38 percent. Additionally, a doubling of serum creatinine level occurred in 1.5 percent of the empagliflozin group compared to 2.6 percent of the placebo group, while the initiation of renal-replacement therapy occurred in 0.3 percent of the empagliflozin group and 0.6 percent of the placebo group. There was no significant between-group difference in the rate of incident albuminuria.

The authors conclude that these findings cannot be generalized to patients with type 2 diabetes at lower cardiovascular risk or to black patients due to the small population included in the study. They explain that moving forward, further research is needed to validate these findings in broader populations at risk for adverse renal outcomes.

In an editorial comment, Julie R. Ingelfinger, MD, and Clifford J. Rosen, MD, write that while these findings “appear encouraging” they “are not a ‘home run’ with regard to the management of diabetes. In the coming years, controlled and comparative effectiveness trials that uniformly combine newer agents with older agents may help to delineate an even more effective treatment plan for the millions of people who lives are affected by type 2 diabetes.” 

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