Pravastatin use and the five-year incidence of cancer in coronary heart disease patients: from the prevention of coronary sclerosis study

BACKGROUND: Although the short-term safety of statins is well established, their potential carcinogenicity in the long term is still being debated. The aim of this study was to investigate the association between statin-therapy and the incidence of cancer in coronary heart disease patients. METHODS: The subjects were 263 patients with coronary heart disease who were from Osaka prefecture and who were admitted to the Osaka Medical Center for Cancer and Cardiovascular Diseases between September 28, 1991 and March 31, 1995. The five-year cancer incidence among the subjects was checked using the database of the institution-based cancer registry of the hospital as well as the population-based Osaka Cancer Registry. The Cox's proportional hazards ratios (HRs) of all cancer incidence and observed/expected (O/E) ratios by cancer site were calculated. RESULTS: Cancer incidence was observed in 17 patients during the follow-up period. Age (HR=1.16 per one year of age) and continuous smoking during the period (HR=5.82 compared to not smoking during the period) were significantly associated with cancer incidence using multivariable analysis. After being adjusted for sex, age, total serum cholesterol level and smoking habit, the HR of cancer incidence with pravastatin use was 0.78 (95% confidence interval: 0.18-3.46). In the O/E analysis, significantly elevated risks were found for bladder cancer in all the subjects (HR=8.93), as well as in the pravastatin use patients (HR=13.76). CONCLUSIONS: Pravastatin use for 5 years did not indicate an increase in over all cancer risk.