Cardiovascular Mortality of Oral Antidiabetic Drugs Approved Before and After the 2008 US FDA Guidance for Industry: A Systemic Review and Meta-Analysis.

ABSTRACT: BACKGROUND:Both diabetes and antidiabetic drugs (ADDs) increase the risk for cardiovascular (CV) diseases. Due to the increasing concern about CV safety associated with ADDs, the US FDA revised regulatory guidelines in 2008 to include CV safety as an endpoint. OBJECTIVE:The objective of the current study was to conduct a systematic review with meta-analysis to compare CV mortality of oral ADDs approved before and after the FDA's 2008 guidance. METHODS:Three electronic databases (PubMed, Scopus, and the Clinical Trial Registry) were searched to retrieve studies published up to 24 February 2017. Randomized clinical trials were included in this study if they (1) were published in the English language; (2) included adults with type 2 diabetes mellitus with or without CV risk factors, who were

SUBMITTER: Goyat R 

PROVIDER: S-EPMC5953843 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature