TY - JOUR
T1 - Fluvastatin treatment is not associated with an increased incidence of cancer
AU - Stein, E. A.
AU - Corsini, A.
AU - Gimpelewicz, C. R.
AU - Bortolini, M.
AU - Gil, M.
PY - 2006/9
Y1 - 2006/9
N2 - 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.
AB - 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.
KW - Cancer
KW - Cholesterol
KW - Fluvastatin
KW - Low-density lipoprotein cholesterol
KW - Randomised controlled trials
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U2 - 10.1111/j.1742-1241.2006.01071.x
DO - 10.1111/j.1742-1241.2006.01071.x
M3 - Article
C2 - 16939542
AN - SCOPUS:33747189175
VL - 60
SP - 1028
EP - 1034
JO - Medicine illustrated
JF - Medicine illustrated
SN - 1368-5031
IS - 9
ER -