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Ed. Note: The following
is a press release from the National Institutes of Health.
Friday, December 17, 2004
The National Institutes of Health (NIH) announced today that it has
suspended the use of COX-2 inhibitor celecoxib (Celebrex™ Pfizer, Inc.)
for all participants in a large colorectal cancer prevention clinical
trial conducted by the National Cancer Institute (NCI). The study, called
the Adenoma Prevention with Celecoxib (APC) trial, was stopped because
analysis by an independent Data Safety and Monitoring Board (DSMB) showed
a 2.5-fold increased risk of major fatal and non-fatal cardiovascular
events for participants taking the drug compared to those on a placebo.
Additional cardiovascular expertise was added to the safety monitoring
committees at the request of the Steering Committees for this trial after
a September 2004 report that the COX-2 inhibitor rofecoxib (Vioxx™) caused
a two-fold increased risk of cardiovascular toxicities in a trial to
prevent adenomas. The APC is a study of more than 2,000 people who have
had a precancerous growth (adenomatous polyp) removed. They were
randomized to take either 200 mg of celecoxib twice a day, 400 mg of
celecoxib twice a day, or a placebo for three years. The trial began in
early 2000 and is scheduled to have been completed by Spring 2005.
Investigators at the 100 sites in the APC trial located primarily in the
United States, with a few additional sites in the United Kingdom,
Australia, and Canada, have been instructed to immediately suspend study
drug use for all participants on the trial, although the participants will
remain under observation for the planned remainder of the study.
“Data from the report on rofecoxib (Vioxx™) informed us of the need to
focus on specific cardiovascular issues, and our Institutes brought in the
experts to do so," said Elias A. Zerhouni, M.D., NIH Director. “Our
overwhelming commitment is to advance the health and to protect the safety
of participants in clinical trials. We are examining the use of these
agents in all NIH-sponsored clinical studies. In addition, we are working
closely with our colleagues at FDA to ensure that the public has the
information they need to make informed decisions about the use of this
class of drug.”
“The rigor of our clinical trials system has allowed us to find this
problem,” said NCI Director Andrew C. von Eschenbach, M.D. “We have a
strong system that provides us with the opportunity to both find ways to
effectively treat and prevent disease and to do so in a way that protects
the lives and safety of the participants.”
NIH sponsors over 40 studies using celecoxib for the prevention and
treatment of cancer, dementia and other diseases. In light of these new
findings, NIH Director Zerhouni requested:
* A full review of all NIH-supported studies involving this class of drug.
* NIH Institutes to inform the principal investigators for all of these
studies and will ask them to communicate directly with their study
participants and explain the risks and benefits
* NIH to ask each investigator to inform us of their plan to analyze their
data in light of the information
* The Institutional Review Boards (IRBs) for all related trials to assess
the new information and to conduct a safety review as well
The NIH comprises the Office of the Director and 27 Institutes and
Centers. The Office of the Director is the central office at NIH, and is
responsible for setting policy for NIH and for planning, managing, and
coordinating the programs and activities of all the NIH components. The
NIH, the Nation's medical research agency, is a component of the U.S.
Department of Health and Human Services.
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