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Research ArticleOpen Access

Vascular Adverse Events Associated with Sitagliptin Agent in Taiwan: A Drug Evaluation Report

Volume 2 - Issue 5

Tzu Chin Rojoice Chou1, Chuan Liang Chou2, Chun Jen Chang2, Chien-Chen Chen3 and Yu-Hsuan Yen*3,4

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    • 1Department of Applied Statistics Information Science and Graduate School of Education, Ming Chuan University, Taiwan
    • 2Department of Endocrinology and Metabolism, Taipei Medical University, Taiwan
    • 3Department of Pharmacy, Taipei Medical University, Taiwan
    • 4School of Pharmacy, Taipei Medical University, Taiwan

    *Corresponding author: Yu-Hsuan Yen, Department of Pharmacy, Wan Fang Hospital, Taipei Medical University School of Pharmacy, Taipei Medical University, No. 111, Hsing Long Road, Section 3, Taipei, Taiwan

Received: February 20, 2018;   Published: March 01, 2018

DOI: 10.26717/BJSTR.2018.02.000815

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Abstract

Objectives: This three-year, long-term study was intended to evaluate the incidence of diabetic macro vascular events, micro vascular events and hypoglycemic events after combining sitagliptin with ant hyperglycemic agents in patients with type 2 diabetes mellitus.

Methods: This is a retrospective observational study of the medical records of type 2 diabetes mellitus patients aged 20 years and older who had been using sitagliptin, metformin and other concomitant ant hyperglycemic agents for more than 60 days from January 1, 2009 to June 30, 2009. All patient medication data were retrieved from the pharmacy database. The primary outcome was to compare the incidence of events such as ischemic stroke, myocardial infarction, peripheral artery occlusive disease, pulmonary embolism, diabetic retinopathy, diabetic nephropathy and severe hypoglycemia in a sitagliptin-based group and a metformin-based group.

Results: Over a mean of 3.6 years, there was a 68% reduced risk of all the adverse events studied in the sitagliptin-based group compared to the metformin-based group. The sitagliptin-base group had a reduction in risk for ischemic stroke, diabetic retinopathy, and diabetic nephropathy. The subgroup analysis results showed that ORs of incidence of events in patients younger than age 65 years, female and with HbA1C less than or equal to 7% after 3 years were significantly lower in the sitagliptin-base group.

Conclusion: Using sitagliptin agents in the treatment of type 2 diabetes mellitus patients may be associated with a reduction in adverse events of vasculopathy

Keywords: Diabetes Mellitus; Sitagliptin; Dpp-4; Metformin; Macrovascular; Microvascular

Abbreviations: HIS: Hospital Information System; IRB: Institutional Review Board; AHAs: Ant Hyperglycemic Agents; IS: Ischemic Stroke; MI: Myocardial Infarction; PAOD: Peripheral Artery Occlusive Disease; PE: Pulmonary Embolism; OR: Odds Ratios; CI: Confidence Intervals; FPG: Fasting Plasma Glucose; HbA1C: Hemoglobin A1A; GLP-1: Glucagon-Like Peptide 1; DPP-4: Dipeptidyl Peptidase IV

Abstract| Introduction| Methods| Study Results| Discussion| Conclusion| References|