The COX2-inhibitor Celebrex® (celecoxib) reduces the rate of colon adenomas at five years and appears safe, even among patients with cardiovascular disease. These results were recently presented as a late-breaking abstract at the 2008 annual meeting of the American Association for Cancer Research.
Adenomas are abnormal growths that often arise in the colon and can potentially turn cancerous. Individuals who have adenomas are at an increased risk of developing future adenomas and are therefore encouraged to undergo more stringent screening, such as colonoscopy. Adenomas are removed during a colonoscopy to prevent the possibility that they may progress to cancer.
Celebrex is a type of non-steroidal anti-inflammatory agent (NSAID) that may be used for controlling pain. Data has indicated that Celebrex may provide protection against the development of colon adenomas and colorectal cancer in some patients. Studies also indicated, however, that Celebrex may increase the risk of cardiovascular side effects. Research continues to evaluate the effectiveness of Celebrex in colon adenomas and colon cancer, as well as potential cardiovascular side effects.
Researchers from several medical institutions conducted a clinical trial, referred to as the Adenoma Prevention with Celecoxib (APC) trial, to evaluate the effectiveness and safety of Celebrex. This trial included more than 2,000 patients who were at a high risk of developing colon adenomas. Patients were treated with either Celebrex (400 mg), Celebrex (800 mg), or placebo (inactive substitute). Three years into the study, data was release about the potential increased risk of cardiovascular side effects associated with Celebrex. At this point the researchers offered patients the opportunity to continue observation for two years.
- At three years the rate of adenomas was reduced by 33% among patients taking lower doses of Celebrex and 45% among those taking higher doses of Celebrex.
- At three years the rate of advanced adenomas was 57% fewer among patients taking lower doses of Celebrex and 66% fewer among those taking higher doses of Celebrex.
- At five years the rate of adenomas was reduced by 41% among patients taking the lower dose of Celebrex and by 25% among those taking the higher dose of Celebrex.
- Cardiovascular events occurred in 8.5% of patients during the time they were taking Celebrex. Patients with a preexisting higher risk of developing cardiovascular complications had a higher rate of these side effects.
The researchers concluded: “[Celebrex] had a high rate of efficacy for reducing adenomas, and it persists even after discontinuing the drug.” However, they continued: “We can’t say that either dose is safe for a patient with cardiac risk factors.”
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Patients who are at a high risk of developing colon adenomas may wish to speak with their physician regarding their individual risks and benefits of Celebrex or the participation in a clinical trial evaluating novel ways to reduce the rate of adenomas. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (www.cancer.gov) and www.eCancerTrials.com.
Reference: Bertagnolli M, et al. Celecoxib reduces sporadic colorectal adenomas: Results from the Adenoma Prevention with Celecoxib (APC) trial. 2008 annual meeting of the American Association for Cancer Research. Abstract CP-3.
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