Statin Therapy and Cancer Risk
Statins do not decrease or increase the risk of cancer overall or cancer of any type, nor do they affect cancer mortality. 1
Evidence on Statin Use and Cancer Risk
Overall Cancer Risk
- Statins do not increase or decrease the risk for incident cancer overall or cancer of any type, based on high-quality evidence from the ACC/AHA guidelines 1
- The Cholesterol Treatment Trialists meta-analysis showed no increase in any cancer with statins compared with placebo 1
- Despite early concerns about carcinogenicity, current evidence does not support the hypothesis that statins affect overall cancer risk when taken at low doses for managing hypercholesterolemia 2
Site-Specific Cancer Risk
- For colorectal cancer, evidence is inconsistent. Some observational studies report a reduction in CRC incidence with statin use (44% reduction in men and 36% in women in a Korean study), while others show no protective effect 1
- For breast cancer, the Women's Health Initiative found no association between statin use and breast cancer over a long period (154,587 postmenopausal women with 7,430 cases of breast cancer over 10.8 years) 1
- Some studies have even reported an 18% lower risk of breast cancer incidence among users of lipophilic statins compared with non-users 1
- For advanced adenomas, a systematic review of 6 observational studies showed statin use was associated with lower risk (RR, 0.83; 95% CI, 0.75–0.92), but not for all adenomas 1
Strength of Evidence
- When grading the level of evidence across cancer types, no cancer type showed convincing evidence of risk reduction with statins 3
- Four cancers (esophageal, hematological, leukemia, and liver cancer) showed suggestive evidence of a preventive effect, but this was not conclusive 3
- None of the meta-analyses of randomized controlled trials on the association of statin and cancer incidence showed statistical significance 3
Current Guidelines and Recommendations
- The American College of Cardiology/American Heart Association (ACC/AHA) guidelines clearly state that statins do not increase or decrease the risk for incident cancer overall or cancer of any type, or the risk for cancer death 1
- For colorectal neoplasia specifically, the American Gastroenterological Association (AGA) clinical practice update states that the role of statins for chemoprevention is presently unclear, and therefore statins should not be used to prevent colorectal neoplasia 1
- The European Association for the Study of the Liver (EASL) guidelines note that despite some meta-analyses suggesting statin use prevents hepatocellular carcinoma (HCC), high heterogeneity in studies precludes robust conclusions 1
Clinical Implications
- The primary indication for statin therapy remains cardiovascular risk reduction, not cancer prevention 1
- Statins reduce CHD and stroke events in adults ≥40 years of age without CHD/CVD across a wide range of baseline LDL-C levels 1
- Statin therapy reduces all-cause mortality by about 10% compared with placebo in primary prevention trials 1
- The benefits of statins for cardiovascular disease prevention outweigh any theoretical cancer-related concerns 1
Limitations and Future Directions
- Most clinical trials of statins have relatively short exposure times, which may be insufficient to fully assess cancer risk 1
- Ongoing clinical trials are exploring the potential of statins to lower mortality and disease-recurrence risk in patients already diagnosed with cancer 4
- Current data cannot exclude possible decreased risks of certain specific cancers, such as gastric, esophageal, liver, colorectal, and advanced/aggressive prostate cancer 2
- Until definitive benefit is demonstrated in randomized controlled trials, statins cannot be recommended for cancer prevention 2