In a new study published in the New England Journal of Medicine, empagliflozin (Jardiance, Eli Lilly) reduced the risk for new-onset or worsening kidney disease by 39% compared with placebo when added to standard of care in adults with type-2 diabetes (T2D) with established cardiovascular (CV) disease. These findings were part of the landmark EMPA-REG OUTCOME trial.
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled study involving more than 7,000 patients with T2D and established CV disease in 42 countries. The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care (SoC) compared with placebo and SoC. SoC consisted of glucose-lowering agents and CV drugs (including blood pressure and cholesterol medications). The study’s primary endpoint was the time to first occurrence of CV death, nonfatal heart attack, or nonfatal stroke.
Over a median period of 3.1 years, empagliflozin significantly reduced the risk of CV death, nonfatal heart attack, or nonfatal stroke by 14% compared with placebo. The risk of CV death was reduced by 38%, with no significant difference in the risk of nonfatal heart attack or nonfatal stroke.
Moreover, compared with placebo, treatment with empagliflozin resulted in the following statistically significant changes in outcomes:
- 55% reduction in the initiation of renal replacement therapy (such as dialysis)
- 44% reduction in doubling of creatinine (a waste product usually filtered by the kidneys) in the blood
- 38% reduction in the progression to macroalbuminuria
Empagliflozin also significantly slowed the decline in kidney function over time compared with placebo. Most patients in this trial were already taking the recommended standard treatment for kidney disease in T2D: renin–angiotensin–aldosterone system blockade. The renal effects of empagliflozin were apparent on top of these agents.
Consistent risk reductions in kidney outcomes with empagliflozin were seen in adults who had impaired kidney function, or increased levels of albumin in the urine, at baseline and in those who did not, according to a post-hoc subgroup analysis.
Serious adverse events and adverse events leading to treatment discontinuation for empagliflozin versus placebo were comparable for patients with or without impaired kidney function at baseline. Death due to renal disease was rare and occurred in three patients treated with empagliflozin (0.1%) and in none treated with placebo.
Source: Eli Lilly; June 14, 2016.