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

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

Business Wire

SAN FRANCISCO -- March 9, 2013

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 62^nd 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

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.”


As noted,  HPS2-THRIVE ( 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

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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


Pamela Eisele, 908-423-5042
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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