Statins did not protect patients against colorectal adenomas, which are benign precursors of colorectal cancer, according to results of a secondary analysis of the Adenoma Prevention with Celecoxib (APC) trial. In a population at high-risk for developing these lesions, results of this analysis suggested statin use may increase the risk of developing benign colorectal tumors.
Researchers presented results of this analysis at the American Association for Cancer Research 101st Annual Meeting 2010, held here, and full study results are published online in Cancer Prevention Research, a journal of the AACR.
"In this analysis, statins did not prevent the development of non-malignant colorectal tumors or colorectal adenomas," said lead researcher Monica Bertagnolli, M.D., chief of the Division of Surgical Oncology at Brigham and Women's Hospital and professor of surgery at Harvard Medical School, Boston, Mass. "Given our results, we do not think that it is reasonable to further study statins for chemoprevention of colorectal cancer, as the chance that they have this activity is very small."
Statins are commonly used to prevent cardiovascular disease by lowering cholesterol levels. Previous studies have indicated that statins may also play a role in the prevention of colorectal cancer among patients who are at high risk for this cancer.
The goal of this study was to determine whether statin use was associated with the development of recurrent colorectal adenomas after removal by colonoscopy.
"We were surprised by our findings; pre-clinical studies indicated that statins would be beneficial, but they were not," Bertagnolli said. "The observation that adenomas were more frequent in patients using statins needs to be confirmed and, because of this study design, should not raise concern. It would be highly detrimental if people at risk for cardiovascular disease were to stop taking statins based on these data."
The overall APC trial was a randomized trial of 2,035 adenoma patients; 679 received placebo, 685 received 200 mg of celecoxib twice a day and 671 received 400 mg of celecoxib twice a day. Celecoxib, marketed by Pfizer, is a non-steroidal anti-inflammatory drug that is commonly used for patients with arthritis.
In the placebo group, patients who used statins at any time had no benefit in tumor growth over a five-year period compared with those patients who never used statins. Statins were used by 36 percent of the participants. Risk of developing recurrent benign colorectal adenomas increased with time in patients who were using statins.
As expected, based on their need for a statin, patients who were taking a statin experienced more serious cardiovascular side effects such as heart attack and stroke, according to the researchers.