Results from HPS2-THRIVE Study of TREDAPTIVE™ (extended-release niacin/laropiprant) Presented at American College of Cardiology Scientific Sessions

Sat Mar 9, 2013 12:50pm EST

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SAN FRANCISCO--(Business Wire)--
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
announced that researchers from the Clinical Trial Service Unit at Oxford
University presented results from the HPS2-THRIVE (Heart Protection Study
2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of
TREDAPTIVE™(extended-release niacin/laropiprant) during a late-breaking clinical
trials session at the American College of Cardiology 62nd Annual Scientific
Sessions (abstract 300-14). HPS2-THRIVE was independently conducted by the
Clinical Trial Service Unit at Oxford University, the regulatory sponsor of the
trial, and funded by Merck. 

Merck previously announced that the study did not meet its primary endpoint
(December 20, 2012 news release). Adding TREDAPTIVE to statin therapy did not
significantly further reduce the risk of major vascular events compared to
statin therapy in patients at high risk of cardiovascular events. Additionally,
there was a statistically significant increase in the incidence of some types of
non-fatal serious adverse events in the group that received TREDAPTIVE. Merck
announced in January that it was taking steps to suspend the availability of
TREDAPTIVE in countries where the medicine has been approved (January 11, 2013
news release). TREDAPTIVE is not approved in the United States. 

The results of HPS2-THRIVE in 25,673 patients were presented by Professor Jane
Armitage, FFPH, FRCP, professor of clinical trials and epidemiology, Oxford
University and the primary investigator for the HPS2-THRIVE study. In the trial,
the composite primary endpoint of major vascular events (coronary death,
non-fatal heart attack, stroke or any arterial revascularization) occurred in
13.2 percent of the patients taking TREDAPTIVE plus statin therapy (n=1,696)
compared to 13.7 percent of the patients taking statin therapy alone (n=1,758)
after a median 3.9 years of follow-up. This corresponded to a risk ratio of 0.96
(95 percent CI: 0.90-1.03; p=0.29). 

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." 

About HPS2-THRIVE

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. 

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest rate
and currency exchange rate fluctuations; the impact of pharmaceutical industry
regulation and health care legislation in the United States and internationally;
global trends toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; Merck ability to
accurately predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck patents and other protections for
innovative products; and the exposure to litigation, including patent
litigation, and/or regulatory actions. 

Merck undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise. Additional
factors that could cause results to differ materially from those described in
the forward-looking statements can be found in Merck`s 2012 Annual Report on
Form 10-K and the company`s other filings with the Securities and Exchange
Commission (SEC) available at the SEC`s Internet site (www.sec.gov).

Merck
Media:
Pamela Eisele, 908-423-5042
Skip Irvine, 267-305-5397
or
Investors:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088 



Copyright Business Wire 2013

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