What does this research mean for the field?

Dipeptidyl peptidase-4 inhibitors, such as sitagliptin, do not improve coronary flow reserve, left ventricular function, or peripheral endothelial function in patients with relatively well-controlled type 2 diabetes mellitus and coronary artery disease. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

May 11, 2018Open Access

Effect of Sitagliptin on Coronary Flow Reserve Assessed by Magnetic Resonance Imaging in Type 2 Diabetic Patients With Coronary Artery Disease

Structured PICO

Does sitagliptin improve coronary flow reserve in patients with type 2 diabetes mellitus and stable coronary artery disease?

Population

30 patients with type 2 diabetes mellitus and stable coronary artery disease, mean age 69, 75% male, based in Japan. Key inclusion: HbA1c 6.1-8.9% without glucose-lowering drugs or 6.5-8.9% with fixed dosages, no ischemic symptoms and no stress-induced myocardial ischemia on cMRI. Key exclusion: eGFR <30 mL/min/1.73 m2, severe liver dysfunction, unstable angina or acute myocardial infarction within 12 weeks, atrial fibrillation, prior use of DPP4i/GLP-1 analog/αGI/insulin, and severe heart failure (NYHA class IV).

Intervention

Sitagliptin 50 mg oral once daily after breakfast (increased to 100 mg/day at 12 weeks if glycemic control was insufficient) for 24 weeks.

Comparator

Voglibose 0.2 mg oral three times daily immediately before each meal (increased to 0.9 mg/day at 12 weeks if glycemic control was insufficient) for 24 weeks.

Outcome

Change in coronary flow reserve (CFR) at 24 weeks compared with baseline, assessed by cardiac magnetic resonance imaging.surrogate

In patients with relatively well-controlled type 2 diabetes and stable coronary artery disease, 24 weeks of sitagliptin therapy did not improve coronary flow reserve, left ventricular function, or peripheral endothelial function compared to voglibose.

Abstract

BACKGROUND: The present study was conducted to assess the cardiovascular effects of dipeptidyl peptidase-4 inhibitors (DPP4i) on coronary flow reserve (CFR), left ventricular (LV) function and endothelial function of the peripheral artery by comparison with those of α-glucosidase inhibitors (αGI) in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD). METHODS AND RESULTS: We randomly assigned 30 patients with T2DM and CAD to receive either sitagliptin or voglibose, and 28 patients (age 69±9 years, 75% male, hemoglobin A1c HbA1c 6.62±0.48%) completed the study (14 in each group). CFR and LV function, assessed by cardiac magnetic resonance imaging, and endothelial function, assessed by reactive hyperemia peripheral arterial tonometry (RH-PAT), were measured at baseline and 24 weeks after treatment. Clinical and laboratory parameters, including HbA1c level, plasma active glucagon-like peptide-1 concentrations, and biomarkers of inflammation, were unchanged in both groups after 24 weeks of treatment. CFR were unchanged in both the αGI group (3.01±0.98 at baseline and 3.06±0.8 after treatment, P=NS) and the DPP4i group (4.29±2.04 at baseline and 3.63±1.31 after treatment, P=NS), with no interaction effect. LV functional parameters and the reactive hyperemia index also remained unchanged after the 24-week treatment. CONCLUSIONS: DPP4i did not improve CFR, LV function or endothelial function of the peripheral artery in patients with relatively well-controlled T2DM and CAD.

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