Physicians' Academy for Cardiovascular Education

DPP-4 inhibitor did not increase adverse events in diabetic patients at high risk

Alogliptin in Patients with Type 2 Diabetes on Metformin and Sulfonylurea Therapies in the EXAMINE Trial

Literature - White WB, Heller SR, Cannon CP, et al. - Am J Med. 2018; published online ahead of print

Introduction and methods

The use of dipeptidyl dipeptidase-4 (DPP-4) inhibitors on top of metformin and sulfonylurea therapy is an effective and well tolerated combination, leading to significant improvements in glycated hemoglobin (HbA1c), but bearing an increased risk of hypoglycemia [1,2].

The Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) Trial was a large cardiovascular (CV) safety study in patients with type 2 diabetes (T2DM) and a recent acute coronary syndrome (ACS), who were randomized to receive alogliptin or placebo on top of standard-of-care-treatment. The study showed comparable CV event rates in the alogliptin and the placebo groups [3,4].

In the present analysis from the EXAMINE Trial, the anti-hyperglycemic efficacy and safety of the addition of alogliptin vs placebo was evaluated in a subgroup receiving metformin and sulfonylurea at baseline (N=1,398). Participants were followed for up to 40 (median 18) months. The change from baseline in HbA1c, adverse events, and CV outcomes were assessed.

Main results


In an analysis of the EXAMINE trial, in T2DM patients with a recent ACS, triple therapy with metformin, sulfonylurea and alogliptin led to significant reductions in HbA1c compared to dual therapy with metformin and sulfonylurea and was well tolerated. The observed reduction in CV death and all-cause mortality supports the CV safety of using alogliptin in a triple therapy regime in T2DM patients at high CV risk.


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