<b>Objective</b>
<p>Type 2 diabetes is a leading
cause of kidney failure, but few outcome trials proactively enrolled
individuals with chronic kidney disease (CKD). We performed
secondary analyses of cardiovascular and kidney outcomes across baseline eGFR
categories (≥ 60, 45-<60, 30-<45 and < 30 ml/min/1.73 m<sup>2</sup>) in
CARMELINA, a cardio-renal placebo-controlled outcome
trial of the DPP-4 inhibitor linagliptin (NCT01897532).</p>
<p><b>Research Design and Methods</b></p>
<p>Participants
with cardiovascular disease (CVD) and/or CKD were included.
The primary outcome was time to first occurrence of cardiovascular death,
non-fatal myocardial infarction, or non-fatal stroke (3P-MACE), with a secondary
outcome renal death, end-stage kidney disease, or sustained ≥40% decrease in
eGFR from baseline. Other endpoints included progression of albuminuria, change
in HbA1c and adverse events (AEs) including hypoglycemia. </p>
<p><b>Results</b></p>
<p>6979 subjects (mean age 65.9
years, eGFR
54.6 ml/min/1.73m<sup>2</sup>, 80.1% albuminuria) were followed for 2.2 years. Across
eGFR categories, linagliptin as compared to placebo did not affect the risk for
3P-MACE (HR.1.02 [95% CI, 0.89, 1.17]), or the secondary kidney outcome (1.04
[0.89, 1.22]) (interaction p-values > 0.05). Regardless of eGFR,
albuminuria-progression was reduced with linagliptin, as was HbA1c, without
increasing risk for hypoglycemia. AEs were balanced between groups overall and
across eGFR categories. </p>
<p><b>Conclusions
</b></p>
<p>Across
all GFR categories, in participants with type 2 diabetes and CKD and/or CVD,
there was no difference in risk for linagliptin versus placebo on CV and kidney
events. Significant reductions in risk for albuminuria progression and HbA1c,
and no difference in AEs was observed.</p>
Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial
