[IP] Here is the news from the NIH on Celebrex]
[quote]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
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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