open access

Vol 69, No 4 (2018)
Review Article
Published online: 2018-08-21
Submitted: 2017-10-11
Accepted: 2018-03-04
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A review of cardiovascular outcome trials in type 2 diabetes

Katarzyna Cypryk, Piotr Małecki
DOI: 10.5603/EP.2018.0053
·
Endokrynologia Polska 2018;69(4):424-440.

open access

Vol 69, No 4 (2018)
Review Article
Published online: 2018-08-21
Submitted: 2017-10-11
Accepted: 2018-03-04

Abstract

Type 2 diabetes is a complex metabolic disorder associated with a high risk of cardiovascular complications. In December 2008, due to concerns about the cardiac safety of antihyperglycaemic therapies, the Food and Drug Administration (FDA) published a new guidance on special requirements for the demonstration of cardiovascular safety for these medications. In 2012, similar recommendations were made for antidiabetic drug manufacturers by the European Medicines Agency (EMA). Since then, both FDA and EMA recommendations have been applied in cardiovascular outcome trials (CVOTs) for several new antihyperglycaemic drugs. Unlike conventional trials, CVOTs are usually placebo controlled, non-inferiority trials that examine the cardiovascular safety of a drug compared to standard of care in large cohorts of patients with high cardiovascular risk or established cardiovascular disease. Patients in CVOTs are also monitored for a longer observation period than in typical randomised controlled trials to provide data on long-term cardiovascular risk. To date, nine CVOTs involving patients with type 2 diabetes have been completed, and at least 13 are still ongoing. These studies focus on a variety of antihyper­glycaemic drugs, including incretin-based agents, sodium-glucose cotransporter 2 inhibitor (SGLT-2) inhibitors, and insulin formulations. This article takes a critical look at these CVOTs and summarises the results of the completed trials.

Abstract

Type 2 diabetes is a complex metabolic disorder associated with a high risk of cardiovascular complications. In December 2008, due to concerns about the cardiac safety of antihyperglycaemic therapies, the Food and Drug Administration (FDA) published a new guidance on special requirements for the demonstration of cardiovascular safety for these medications. In 2012, similar recommendations were made for antidiabetic drug manufacturers by the European Medicines Agency (EMA). Since then, both FDA and EMA recommendations have been applied in cardiovascular outcome trials (CVOTs) for several new antihyperglycaemic drugs. Unlike conventional trials, CVOTs are usually placebo controlled, non-inferiority trials that examine the cardiovascular safety of a drug compared to standard of care in large cohorts of patients with high cardiovascular risk or established cardiovascular disease. Patients in CVOTs are also monitored for a longer observation period than in typical randomised controlled trials to provide data on long-term cardiovascular risk. To date, nine CVOTs involving patients with type 2 diabetes have been completed, and at least 13 are still ongoing. These studies focus on a variety of antihyper­glycaemic drugs, including incretin-based agents, sodium-glucose cotransporter 2 inhibitor (SGLT-2) inhibitors, and insulin formulations. This article takes a critical look at these CVOTs and summarises the results of the completed trials.

Get Citation

Keywords

type 2 diabetes mellitus; cardiovascular disease; hyperglycaemia

About this article
Title

A review of cardiovascular outcome trials in type 2 diabetes

Journal

Endokrynologia Polska

Issue

Vol 69, No 4 (2018)

Pages

424-440

Published online

2018-08-21

DOI

10.5603/EP.2018.0053

Bibliographic record

Endokrynologia Polska 2018;69(4):424-440.

Keywords

type 2 diabetes mellitus
cardiovascular disease
hyperglycaemia

Authors

Katarzyna Cypryk
Piotr Małecki

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