New Research Shows that Celebrex Helps Stop Growth of Pre-Cancerous Colorectal Polyps in Patients at High Risk for Colon Cancer
“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 -- 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.
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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.
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