According to a press release from Pfizer, results from two clinical trials suggest that Celebrex® (celecoxib) reduces the growth of precancerous colorectal polyps in patients at increased risk for colorectal cancer.
Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. The disease develops in the colon (the longest part of the large intestine) or the rectum (the last several inches of the large intestine). It also may start as a precancerous growth known as an adenomatous polyp.
Celebrex belongs to the class of drugs known as non-steroidal anti-inflammatory agents. Celebrex inhibits the COX-2 enzyme, which plays a role in inflammatation.
The COX-2 enzyme is overexpressed in many colorectal cancers, suggesting that inhibitors of this enzyme may play a role in prevention or treatment. Some studies, however, have linked COX-2 inhibitors with an increased risk of cardiovascular problems.
Results from two clinical trials of Celebrex were recently presented at a meeting of the American Association for Cancer Research. Both trials evaluated whether Celebrex stops the growth precancerous colorectal polyps.
The trials enrolled patients who had already had colorectal polyps removed. Patients were randomly assigned to treatment with Celebrex or placebo, and were evaluated for the development of new colorectal polyps. Both studies assessed long-term use of higher doses of Celebrex.
In the first trial, the Adenoma Prevention with Celecoxib (APC) trial, patients assigned to treatment with Celebrex took either 400 mg or 800 mg per day. Colorectal adenomas developed in 42% of patients taking the 400 mg dose, 37% of patients taking the 800 mg dose, and 61% of patients in the placebo group.
In the second trial, the Prevention of Sporadic Adenomatous Polyps (PreSAP) trial, patients assigned to treatment with Celebrex took 400 mg per day. During the three-year study period, colorectal adenomas developed in 34% of patients taking Celebrex and 49% of patients in the placebo group.
In both trials, Celebrex produced the largest benefit among patients who had initially been diagnosed with the most advanced polyps.
Patients who took Celebrex were also more likely to develop cardiovascular problems.
These results suggest that long-term use of higher doses of Celebrex decreases the risk of colorectal polyps, but increases the risk of cardiovascular problems. Patients who are considering taking Celebrex may wish to discuss the risks and benefits with their physician.
Reference:Pfizer Inc. Investor News Release. New Research Shows that Celebrex Helps Stop Growth of Pre-Cancerous Colorectal Polyps in Patients at High-Risk for Colon Cancer. April 3, 2006. Available at http://www.pfizer.com/pfizer/are/investors_releases/2006pr/mn_2006_0403.jsp (Accessed April 4, 2006).