Abstract

BackgroundThere have only been a few reports about use of dipeptidyl peptidase 4 (DPP-4) inhibitors in elderly patients with type 2 diabetes mellitus (T2DM), suggesting that the safety of these agents has not been sufficiently demonstrated. We performed a comparative review of the efficacy and safety of sitagliptin for Japanese patients with T2DM managed in the real-world clinical setting.MethodsAn age-stratified analysis was performed of 831 patients who were treated with sitagliptin for 2 years. Parameters assessed included the hemoglobin A1c (HbA1c), body weight, serum creatinine, and adverse events. HbA1c and the incidence of hypoglycemia were also evaluated in patients treated with sitagliptin and a sulfonylurea (SU), who were divided into three age groups (<65 years, 65–74 years, and ≥75 years).ResultsComparison of glycemic control parameters, laboratory values, and adverse events revealed significant improvement of HbA1c, casual postprandial plasma glucose, and fasting plasma glucose in each age group with no change in body weight. Serum creatinine increased significantly in all age groups. Hypoglycemia only occurred in patients who received combined treatment with an SU and sitagliptin, and there was no age-related difference in its incidence.ConclusionsHbA1c was improved by 2 years of sitagliptin therapy in all three age groups, and age did not seem to influence the incidence of hypoglycemic events. These results confirm the efficacy and safety of sitagliptin in patients ≥ 75 years old, suggesting that it is also useful for treating elderly patients with T2DM.

Highlights

  • There have only been a few reports about use of dipeptidyl peptidase 4 (DPP-4) inhibitors in elderly patients with type 2 diabetes mellitus (T2DM), suggesting that the safety of these agents has not been sufficiently demonstrated

  • We previously investigated the efficacy and safety of sitagliptin for Japanese T2DM patients treated in the real-world setting [17]

  • The Diabetes Committee of the Kanagawa Physicians Association conducted the ASSET-K study involving over 1,000 patients [17, 18, 22,23,24,25], and concluded that factors influencing the reduction in hemoglobin A1c (HbA1c) by sitagliptin in patients taking other oral antidiabetic agents were a high baseline HbA1c, short duration of diabetes, and low body mass index at the initiation of sitagliptin therapy

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Summary

Introduction

There have only been a few reports about use of dipeptidyl peptidase 4 (DPP-4) inhibitors in elderly patients with type 2 diabetes mellitus (T2DM), suggesting that the safety of these agents has not been sufficiently demonstrated. Patients are more likely to develop hypoglycemia than younger patients when treated with multiple drugs, as well as immediately after discharge from hospital, if they have renal failure, and if their diet is poor, and they are less likely to detect the onset of hypoglycemia [8, 9]. Sitagliptin was the first dipeptidyl peptidase 4 (DPP-4) inhibitor to be released for clinical use It is an oral hypoglycemic drug with a glucose-dependent mechanism of action via glucagon-like peptide 1 and glucosedependent insulinotropic polypeptide, which makes it less likely to cause hypoglycemia [10, 11]. There have only been a few reports about use of DPP-4 inhibitors in elderly patients with T2DM, and the safety of sitagliptin has not been demonstrated sufficiently

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