Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments

AstraZeneca113,505 enrolled

Overview

The purpose of this study is to compare the incidence of major cardiovascular events among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of oral anti-diabetic drugs (OADs)in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Study Type

OBSERVATIONAL

Enrollment

113,505

Conditions

Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors * Enrolled in the respective database for at least 180 days prior to the first prescription for Saxagliptin or other OAD in a class other than DPP4 inhibitors Exclusion Criteria: * Patients identified with a diagnostic code for any of the cardiovascular outcomes of interest within the 180-day baseline period * Patients prescribed a DPP4 inhibitor during the baseline period

Outcomes

Primary Outcomes

Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease

Myocardial infarction (MI), congestive heart failure (CHF), deep venous thrombosis (DVT), pulmonary embolism (PE)

Time frame: 18-months

Time frame: 36-months

Time frame: 54-months

Secondary Outcomes

Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined

Time frame: 18-months

Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined

Time frame: 36-months

Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined

Time frame: 54-months

All-cause death

Time frame: 18-months

All-cause death

Data from ClinicalTrials.gov

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