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Saturday 18th December, 2004
Celebrex more than doubled heart deaths, heart attacks, and strokes in people
enrolled in a cancer-prevention study, research shows.
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
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."
However, another ongoing study looking at whether Celebrex
can prevent colon cancer has not found any increased risk of
heart attacks in patients taking the drug. This trial, the
PreSAP trial, used the same heart measures and the same safety
monitoring board as the APC trial.
"Pfizer is taking immediate steps to fully understand the [APC
study] results and rapidly communicate new information to
regulators, physicians, and patients around the world," Pfizer
CEO Hank McKinnell says in a news release.
Because the two studies came up with opposite findings -- and
because earlier studies showed no obvious sign of heart problems
linked to Celebrex -- the FDA has not yet decided whether to ban
Celebrex, to add additional warnings to the drug's label, or to
wait for more information. But Acting FDA Commissioner Lester
Crawford, MD, says the agency won't drag its feet.
"We will evaluate this information and may make statements
very soon with regard to Cox-2 drugs in general and this product
in specific," Crawford said today in a joint FDA/National
Institutes of Health news conference.
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
- NIH to ask each investigator to inform us of the 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
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