'Both trials showed the highest benefit in people who had the most advanced
polyps -- which have a higher risk of developing into cancer'
Sustained Higher Doses for Almost Three Years Reduced Occurrence of
Pre-Cancerous Polyps Up to 45 Percent; No Differences in the Rates of
Gastrointestinal Events in Patients Taking Celebrex Compared to Patients
Taking Placebo
Cardiovascular Safety Results From Cancer Prevention Trials Are Consistent
with Celebrex Label
NEW YORK, April 3 /PRNewswire-FirstCall/ -- Two major long-term clinical
trials presented today at the American Association for Cancer Research meeting
showed that Pfizer's COX-2 inhibitor, Celebrex (celecoxib), helps stop the
growth of pre-cancerous polyps (adenomas) that can lead to colon cancer.
The investigational trials -- the Adenoma Prevention with Celecoxib (APC)
trial, co-sponsored by the National Cancer Institute and Pfizer, and the
Prevention of Sporadic Adenomatous Polyps (PreSAP) trial, sponsored by Pfizer
-- found that sustained, higher doses of Celebrex for almost three years
reduce pre-cancerous polyps (adenomas) with the greatest benefit for those at
highest risk of polyp recurrence.
Both trials enrolled patients who had already had precancerous colon
polyps removed. They were about 60 years old, on average, at the start of the
trial; the majority had cardiovascular risk factors such as high blood
pressure, diabetes, angina, previous heart attacks, strokes or were smokers.
In the PreSAP trial, 34 out of 100 patients on Celebrex 400 mg developed
pre-cancerous polyps over the three-year study period, compared to 49 out of
100 receiving no medication (placebo). In the APC study, 42 out of 100 on the
400 mg dose and 37 out of 100 on the 800 mg dose of Celebrex developed
pre-cancerous polyps, compared to 61 out of 100 patients receiving no
medication. Overall this represents up to a 45 percent reduction in the
development of pre-cancerous polyps.
One out of five adenomas in the colon develops into colon cancer if not
removed. The trials were designed to test whether Celebrex, a COX-2 inhibitor,
could help prevent the pre-cancerous polyps by blocking the COX-2 enzyme that
has been shown to be a possible factor in the formation of pre-cancerous
polyps (benign tumors). Pre-cancerous polyps, if left undetected and
untreated, can grow into full-blown colon cancer and spread.
"Importantly, both trials showed the largest benefit in people who had the
most advanced polyps -- which have a higher risk of developing into cancer,"
said Dr. Joseph Feczko, chief medical officer at Pfizer. "Colorectal cancer
takes years to develop and frequently starts with an adenomatous polyp that
transforms over many years into cancer. These trials reflect the growing focus
on the use of pharmaceutical medicines in cancer prevention."
In designing the trials, researchers also considered Celebrex's
gastrointestinal safety profile. "This is one of the key reasons we chose
Celebrex," said Dr. Nadir Arber, principal investigator of the PreSAP trial
and head of the Gastrointestinal Oncology Unit, Tel Aviv Sourasky Medical
Center, Israel. "Regular Non-Steroidal Anti-Inflammatories (NSAIDs), such as
prescription-strength ibuprofen and naproxen, may also work, but at the high
doses needed in cancer prevention trials, there would be an unacceptable
patient risk for GI complications. The high doses of Celebrex in these
studies had minimal effects on the entire gastrointestinal tract."
Patients in APC took 400 mg twice daily and 200 mg twice daily of
Celebrex, and in PreSAP 400 mg once daily, for an average of 33 months. These
trials were specifically designed to study Celebrex at these higher, long-term
doses, which is different from the way osteoarthritis patients use Celebrex.
This is typically at 200 mg doses daily for shorter periods of time. There
were no differences in the rates of gastrointestinal events in Celebrex
patients compared to patients taking placebo. However, the trials were not
designed to examine gastrointestinal safety, and there were too few safety
events to draw definitive conclusions.
As reported in late 2004 based on a preliminary analysis, the final
results of APC demonstrated a statistically significant increase in the
Celebrex group compared to placebo for serious cardiovascular events, while
PreSAP did not. A new, broader analysis of serious and other cardiovascular
events, including angina, for both APC and PreSAP, found more cardiovascular
events with Celebrex compared to placebo. These results are consistent with
the current warnings on cardiovascular risk in the Celebrex label.
"The current Celebrex label, which was updated last July, reflects the
benefit-risk profile for arthritis patients," said Dr. Feczko. "The evidence
available today is that the typical arthritis dose of 200 mg of Celebrex taken
daily does not increase the risk of cardiovascular events compared to other
common prescription arthritis pain relievers (NSAIDs). Chronic arthritis pain
typically needs to be treated with NSAIDs -- be it Celebrex or prescription
strength ibuprofen or naproxen -- and current scientific data suggest that all
prescription NSAIDs may have similar cardiovascular risks. For millions of
arthritis patients, Celebrex is an important treatment option."
Pfizer has provided available information about APC and PreSAP to
regulatory agencies around the world. Pfizer will submit final study reports
to the FDA and other regulatory agencies.
Pfizer supports the cardiovascular safety study, PRECISION, led by the
Cleveland Clinic and sponsored by Pfizer, which is expected to provide
additional information to help doctors and patients make informed choices
about relieving arthritis pain. The worldwide trial, which will involve
approximately 20,000 patients, will assess the safety of the three most
commonly used pain relievers including ibuprofen, naproxen and Celebrex in
arthritis patients at risk for, or with heart disease.
For detailed information regarding the safety and efficacy profile of
Celebrex, including important warnings on cardiovascular and gastrointestinal
safety, please visit Celebrex.com, where the full U.S. prescribing label is
available.
DISCLOSURE NOTICE: The information contained in this release is as of
April 3, 2006. Pfizer assumes no obligation to update any forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about certain potential
benefits of Celebrex that involves substantial risks and uncertainties. Such
risks and uncertainties include, among other things, the uncertainties
inherent in research and development; decisions by regulatory authorities
regarding whether and when to approve any supplemental drug applications that
may be filed for additional indications for Celebrex as well as their
decisions regarding labeling and other matters that could affect the
availability or commercial potential of Celebrex for any such additional
indications; and competitive developments.
A further list and description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31,
2005 and in its reports on Form 10-Q and Form 8-K.
SOURCE Pfizer Inc
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