2016 - In patients with type 2 diabetes and CVD, empagliflozin reduced incident or worsening nephropathy at 3.1 y.

Question In patients with type 2 diabetes and cardiovascular disease (CVD), how does adding empagliflozin to standard care affect renal outcomes? Methods Design Secondary analysis of a randomized placebo-controlled trial (EMPA-REG OUTCOME trial). ClinicalTrials.gov NCT01131676. Allocation {Concealed}*.† Blinding Blinded† {patients, clinicians, data collectors, outcome adjudicators, data analysts, and manuscript writers}‡. Follow-up period Median 3.1 years. Setting 590 centers in 42 countries. Patients {7028}* patients (mean age 63 y, 71% men) who had type 2 diabetes, established CVD, and an estimated glomerular filtration rate (eGFR) ࣙ 30 mL/min/1.73 m[sup 2]. Intervention Empagliflozin, 10 mg/d {n = 2345 treated}*; empagliflozin, 25 mg/d {n = 2342 treated}*; or placebo {n = 2333 treated}*. All patients received standard care. Outcomes Main outcome was a component of a prespecified composite secondary outcome: incident or worsening nephropathy (progression to macroalbuminuria, serum creatinine level doubling and eGFR ࣘ 45 mL/min/1.73 m[sup 2], renal replacement therapy initiation, or death due to renal disease). Other outcomes included components of incident or worsening nephropathy and incident albuminuria (urinary albumin-creatinine ratio ࣙ 30) in patients with normal baseline albumin levels. Patient follow-up {97% completed the study}*; 99.9% were included in the modified intention-to-treat analysis. Main results Empagliflozin, 10 mg or 25 mg daily, reduced incident or worsening nephropathy compared with placebo (Table). Results were similar for each dose of empagliflozin vs placebo (10 mg, hazard ratio [HR] 0.61, 95% CI 0.53 to 0.72; 25 mg, HR 0.61, CI 0.52 to 0.71). Groups did not differ for incident albuminuria (Table). Conclusion In patients with type 2 diabetes and cardiovascular disease, adding empagliflozin to standard care reduced incident or worsening nephropathy at a median 3.1 years.