The primary composite outcome in the EMPA-REG OUTCOME® trial was 3-point MACE, composed of death from CV causes, nonfatal MI, or nonfatal stroke. Hospitalization for heart failure was a key secondary, all-cause mortality was an exploratory outcome.
In the EMPA-REG OUTCOME® trial new or worsening nephropathy was a prespecified component of the secondary microvascular outcome, defined as new-onset macroalbuminuria, doubling of serum creatinine level accompanied by an eGFR ≤45 mL/min/1.73m2, initiation of continuous renal replacement therapy, death due to renal disease. Other prespecified renal microvascular outcomes were a composite of incident or worsening nephropathy or death from cardiovascular causes, the individual components of incident or worsening nephropathy, and incident albuminuria (urinary albumin-to-creatinine ratio, ≥30) in patients with a normal albumin level (urinary albumin-to-creatinine ratio, <30) at baseline. Renal function over time, as measured by eGFR, was a safety outcome.
In addition to statements regarding primary results of EMPA-REG OUTCOME published by Zinman B et al. (N Engl J Med 2015;373:2117-28.), the video also comprises data on renal outcomes of the study, published by Wanner C et al. (N Engl J Med 2016;375:323-34).
