Concerns regarding a potential link between
statin treatment and increased risk of
cancer were raised following the increased
cancer incidence observed in patients treated with
pravastatin in the
Cholesterol and Recurrent Events and
Pravastatin in Elderly Individuals at Risk of
Vascular Disease studies. The aim of the present study was to investigate the risk of
cancer associated with
fluvastatin treatment in clinical trials. A pooled analysis of all available, randomised, placebo-controlled trials with
fluvastatin with a minimum treatment period of 24 weeks was performed. The
cancer incidences were compared in 3512 patients receiving
fluvastatin, 20-80 mg/day, and 3289 patients receiving placebo. Overall, fewer patients were diagnosed with
cancer in the
fluvastatin group compared with the placebo group [220/3512 (6.3%) vs. 263/3289 (8.0%) respectively; p = 0.0309]. Cox regression analysis, adjusted for baseline covariates and stratified by study, revealed a hazard ratio for first
cancer diagnosis of 0.812 [95% confidence interval (CI) 0.667-0.989; p = 0.037] for
fluvastatin compared with placebo. No significant differences were observed in the incidence of
cancers by site, with the exception of non-
melanoma skin cancer (103 vs. 125 cases in the
fluvastatin and placebo groups respectively; p = 0.047). Cox regression analysis showed that there was no association between baseline
low-density lipoprotein cholesterol levels and the risk of developing
cancer (hazard ratio 0.998, 95% CI 0.995-1.000; p = 0.107). In conclusion,
fluvastatin treatment is not associated with an increased risk of
cancer compared with placebo in clinical trials, independent of patient age,
treatment duration and baseline
cholesterol levels.