Nonclinical and clinical pharmacology evidence for cardiovascular safety of saxagliptin.

ABSTRACT:

Background

In the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial in patients with type 2 diabetes mellitus (T2D) at high risk of cardiovascular (CV) disease, saxagliptin did not increase the risk for major CV adverse events. However, there was an unexpected imbalance in events of hospitalization for heart failure (hHF), one of six components of the secondary CV composite endpoint, with a greater number of events observed with saxagliptin. Here, we examined findings from nonclinical safety and clinical pharmacology studies of saxagliptin with the aim of identifying any potential signals of myocardial injury.

Methods

In vitro and in vivo (rat, dog, monkey) safety pharmacology and toxicology studies evaluating the potential

SUBMITTER: Pollack PS 

PROVIDER: S-EPMC5598064 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature