Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Empagliflozin Use in Patients with T2D, CVD & CKD

Circulation; 2018 Jan; Wanner, Lachin, et al

In patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease (CKD), treatment with empagliflozin improved clinical outcomes and reduced mortality, a recent study found. Patients with type 2 diabetes mellitus, established CVD, and estimated glomerular filtration rate (eGFR) ≥30 mL·min-1·1.73 m-2 at screening were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily in addition to standard of care. Researchers found:

  • 7,020 patients were treated: 2,250 had prevalent CKD at baseline, of whom 67% had a diagnosis of type 2 diabetes mellitus for >10 years, 58% were receiving insulin, and 84% were taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.
  • In patients with prevalent kidney disease at baseline, empagliflozin reduced the risk of CV death by 29% compared with placebo, the risk of all-cause mortality by 24%, the risk of hospitalization for heart failure by 39%, and the risk of all-cause hospitalization by 19%.
  • Effects of empagliflozin on outcomes was consistent across categories of eGFR.

Citation:

Wanner C, Lachin JM, Inzucchi SE, et al. Empagliflozin and clinical outcomes in patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease. Circulation. doi:10.1161/CIRCULATIONAHA.117.028268.

Commentary:

The Empa-Reg Outcome trial was the first of the cardiovascular (CV) outcome trials (CVOTs) to show a positive effect on CV outcomes. In the original study in the empagliflozin group, there were significantly lower rates of death from CV causes (3.7% vs 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction).1 This report shows that the improvement in CV outcomes occurs equally for those with severe kidney disease (Stage IV - (GFR = 15-29 mL/min) as for those with better kidney function. — Neil Skolnik, MD

  1. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117-2128. doi:10.1056/NEJMoa1504720.

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