NIH Halts Use of COX-2 Inhibitor in Large Cancer
Prevention Trial 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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