Printer Friendly

AstraZeneca reports meeting of primary end point by Brilinta's phase III THEMIS trial.

M2 PHARMA-February 26, 2019-AstraZeneca reports meeting of primary end point by Brilinta's phase III THEMIS trial

(C)2019 M2 COMMUNICATIONS

AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Monday that the phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE), as compared to aspirin alone.

Reportedly, THEMIS was conducted in over 19,000 patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior heart attack (myocardial infarction, MI) or stroke. Preliminary safety results were consistent with the known profile of Brilinta.

According to the company. a full evaluation of the THEMIS data will be presented at a forthcoming medical meeting. The full results from the THEMIS trial are expected to be presented later this year.

THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is an AstraZeneca-sponsored, multi-national, randomised, double-blinded trial in patients with CAD and T2D with no prior myocardial infarction or stroke. THEMIS was designed to test the hypothesis that Brilinta plus aspirin would reduce major adverse cardiovascular events (MACE), a composite of CV death, myocardial infarction or stroke, in patients with CAD and T2D with no prior myocardial infarction or stroke, vs. aspirin alone. CAD was defined as a prior percutaneous coronary intervention (PCI), bypass surgery or at least a 50% narrowing of a coronary artery.

This trial was initiated in early 2014, duration was event-driven across 42 countries and more than 19,000 patients were randomised in order to collect 1,385 independently-adjudicated primary endpoint events.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.

((Comments on this story may be sent to info@m2.com))

COPYRIGHT 2019 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2019 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 Pharma
Date:Feb 26, 2019
Words:313
Previous Article:BioInvent widens loss in 2018.
Next Article:Eisai Inc submits sNDA with US FDA to update the labeling of anti-obesity agent BELVIQ (lorcaserin HCl).
Topics:

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters