diabetes-v2The New England Journal of Medicine today shared landmark results from the EMPA-REG OUTCOME trial. The study revealed a marked reduction in cardiovascular (CV) mortality and morbidity for high CV risk type 2 diabetes patients when taking empagliflozin (a sodium glucose cotransporter 2 inhibitor).

Throughout the randomized, double-blind, placebo-controlled trial, all cardiovascular events were prospectively adjudicated by an independent committee of medical experts, managed by ACI Clinical. This met FDA Guidance recommendations to demonstrate that a new type 2 diabetes therapy does not increase CV risk.

As provider of the study’s CV Endpoint Adjudication Committee services, ACI Clinical is honored to have supported the EMPA-REG OUTCOME trial. By demonstrating a reduction in CV mortality and morbidity, this important study is a milestone in CV outcomes for anti-diabetic therapies.

New England Journal of Medicine article
http://www.nejm.org/doi/full/10.1056/NEJMoa1504720

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FDA Guidance
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf