Pravastatin use and cancer risk: a meta-analysis of individual patient data from long-term prospective controlled trials in Japan.
OBJECTIVE
To assess the influence of pravastatin therapy on cancer morbidity and mortality by a meta-analysis of individual patient data (IPD) from three independent Japanese large-scale clinical trials.


METHODS
We conducted a meta-analysis of IPD collected from three large-scale prospective studies, the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study, Kyushu Lipid Intervention Study (KLIS), and Hokuriku Lipid Coronary Heart Disease Study-Pravastatin Atherosclerosis Trial (Holicos-PAT), which compared cardiovascular outcomes with pravastatin therapy and non-statin therapy in Japanese patients with hypercholesterolemia over a follow-up period of >or=4 years. The incidence of cancer or cancer death in the pravastatin and non-statin therapy groups was compared by multivariate Cox proportional hazard models stratified by trial. Subgroup analyses by sex and age were also conducted using the same methods.


RESULTS
In a total of 13 724 patients (mean age, 58 years; women, 48%) included in the analyses, pravastatin was not associated with an increased risk of developing cancer (hazard ratio [HR], 0.99; 95% confidence interval [95%CI], 0.81-1.19). Similarly, pravastatin therapy did not statistically affect cancer death (HR, 0.86; 95%CI, 0.61-1.21). Moreover, in subgroups analyses, no influence was observed on cancer incidence or death in relation to sex and age.


CONCLUSIONS
Pravastatin did not increase the rate of cancer incidence or cancer death in a large population of Japanese patients followed for >70,000 patient-years.
Matsushita
Yasuyuki
Y
Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan. matsushita.yasuyuki.ks@daiichisankyo.co.jp
Sugihara
Masahiro
M
Kaburagi
Junpei
J
Ozawa
Masumi
M
Iwashita
Mikio
M
Yoshida
Sanae
S
Saito
Hanako
H
Hattori
Yoko
Y
D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000494:pharmacology*; D018849:Controlled Clinical Trials as Topic; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D017035:Pravastatin / Q000009:adverse effects / Q000494:pharmacology*; D012307:Risk Factors
D000924:Anticholesteremic Agents; D017035:Pravastatin