Data from the EMPA-REG study were unveiled in Stockholm 6 weeks ago. In more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV events, EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of JARDIANCE, when added to standard of care, in CV risk reduction. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke.
On November 7th, at ASN's Renal Week in San Diego, top-line renal data from this same study showed equally impressive results. Of the 7020 patients studied, approximately 1800 had eGFR < 45 ml/min, 750 had macroalbuminuria and 80% were on renin-angionsin system blockers. Patients with GFR <60 ml/min randomized to empgliflozin experienced a significant reduction in the composite renal end-point of creatinine doubling, ESRD or renal death. As well, new onset worsening of nephropathy plus traditional outcomes were reduced in the empagliflozin group (HR 0.61 95%CI 0.53-0.7). What's more, the impact of empagliflozin on the primary end-point was not diminished in patients with CKD compared to those without it (MACE HR 0.88, CV death HR 0.78, heart failure HR 0.59, all-cause mortality HR 0.80, no signal of MI, stroke).
We eagerly await the publication of the renal sub-study however, at the moment, empagliflozin (and possibly the whole SGLT2 inhibitor class) represents a towering milestone in the management of patients with type 2 diabetes.