Statins are widely prescribed for
cardiovascular disease prevention and also commonly used in patients at high risk for
colorectal cancer. We report the results of a planned secondary analysis of the relationship between
statin use and colorectal
adenoma risk in a large
chemoprevention trial. The
Adenoma Prevention with
Celecoxib (APC) trial randomized 2,035
adenoma patients to receive placebo (679 patients), 200 mg
celecoxib twice daily (bid; 685 patients), or 400 mg
celecoxib bid (671 patients). The study collected complete medical history and medication use data and performed colonoscopic surveillance to 5 years after study enrollment. The effects of
statin use on newly detected
adenomas and cardiovascular adverse events were analyzed as time-dependent variables by multivariable Cox regression.
Statins were used by 36% (n = 730) of APC trial participants. When adjusted for covariates including cardioprotective
aspirin use, age, and sex, participants on the placebo arm who used
statins at any time had no benefit over 5 years compared with never users (risk ratio, 1.24; 95% confidence interval, 0.99-1.56; P = 0.065).
Statin use for >3 years increased
adenoma risk over 5 years (risk ratio, 1.39; 95% confidence interval, 1.04-1.86; P = 0.024). For all comparisons of patients treated with
celecoxib,
adenoma detection rates for
statin users and nonusers were equivalent. Consistent with their use in patients at high risk, cardiovascular serious adverse events were more common among
statin users. For patients at high risk of
colorectal cancer,
statins do not protect against
colorectal neoplasms and may even increase the risk of developing colorectal
adenomas.