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


March 9, 2013 12:50 pm ET

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

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

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

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