As previously disclosed, there were statistically significant increases in non-fatal serious adverse events observed in patients taking TREDAPTIVE plus statin therapy compared to patients taking placebo plus statin therapy. These events included: diabetic complications, new onset diabetes, infection, gastrointestinal, musculoskeletal, bleeding (including gastrointestinal and intracranial) and skin. There was also a small excess in heart failure.
“Merck has a long and proud history of supporting major outcomes studies to investigate challenging scientific questions and advance our collective understanding of cardiovascular medicine,” said Michael Mendelsohn, M.D., senior vice president, cardiovascular medicine, Merck Research Laboratories. “The results of HPS2-THRIVE add substantially to the body of scientific knowledge in this important therapeutic area.”
As noted, HPS2-THRIVE (Clinicaltrials.gov identifier: NCT 00461630) was independently conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck. The study enrolled 25,673 patients considered to be at high risk for cardiovascular events. Of those enrolled, 14,741 were from Europe (the United Kingdom and Scandinavia) and 10,932 were from China. HPS2-THRIVE compared extended-release niacin and laropiprant (a flushing pathway inhibitor) plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either extended-release niacin or laropiprant.About Merck Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube. Forward-Looking Statement This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.