Merck Announces HPS2-THRIVE Study of TREDAPTIVE™ (Extended-Release
Niacin/Laropiprant) Did Not Achieve Primary Endpoint
WHITEHOUSE STATION, N.J. -- December 20, 2012
Merck (NYSE:MRK), known outside the United States and Canada as MSD, today
announced that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to
Reduce the Incidence of Vascular Events) study of
TREDAPTIVE^™(extended-release niacin/laropiprant) did not meet its primary
endpoint. Merck and the investigators are informing regulatory agencies of
these results. The company is also preparing communications to health care
providers in countries where the medicine is currently available, and will
continue to work with regulators to provide updated information to health care
providers. Based on the current understanding of these new data and until
further analyses can be completed, Merck is recommending that providers not
start new patients on TREDAPTIVE. Merck does not plan to seek regulatory
approval for the medicine in the United States.
HPS2-THRIVE 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. Patients in the study were followed for a median of 3.9 years.
HPS2-THRIVE compared extended -release niacin and laropiprant plus statin
therapy versus statin therapy. It was not designed to assess directly the
separate effects of either extended-release niacin or laropiprant.
In the study, adding the combination of extended-release niacin and
laropiprant to statin therapy did not significantly further reduce the risk of
the combination of coronary deaths, non-fatal heart attacks, strokes or
revascularizations compared to statin therapy. In addition, there was a
statistically significant increase in the incidence of some types of non-fatal
serious adverse events in the group that received extended-release
With the agreement of the independent research team at Oxford University,
Merck is sharing results from the study with regulatory agencies in countries
where the medicine is approved (under the brand names TREDAPTIVE or
CORDAPTIVE) and in other countries as well. The investigators are conducting
additional analyses, including regional analyses, to further understand the
results. They anticipate reporting the detailed study results in the first
quarter of 2013.
"While we are disappointed in these results, we thank the investigators who
have conducted the study and the patients who have participated in it,” said
Peter S. Kim, Ph.D., president, Merck Research Laboratories. “We are committed
to working closely with the independent research team at Oxford University and
with regulatory agencies to understand the results and determine next steps."
TREDAPTIVE/CORDAPTIVE has been approved in approximately 70 countries,
including in Europe, and is sold in approximately 40 countries. TREDAPTIVE is
also sold under the brand names PELZONT in Italy and TREVACLYN in Italy and
Portugal. Sales through the first three quarters of 2012 were approximately
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Additional factors that could cause results to differ materially from those
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Pamela Eisele, 908-423-5042
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465
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