Pravastatin use and cancer risk: a meta-analysis of individual patient data from long-term prospective controlled trials in Japan

Pharmacoepidemiol Drug Saf. 2010 Feb;19(2):196-202. doi: 10.1002/pds.1870.


Purpose: 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.

Conclusion: 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.

Publication types

  • Meta-Analysis

MeSH terms

  • Anticholesteremic Agents / adverse effects
  • Anticholesteremic Agents / pharmacology*
  • Controlled Clinical Trials as Topic
  • Female
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Neoplasms* / complications
  • Pravastatin / adverse effects
  • Pravastatin / pharmacology*
  • Risk Factors


  • Anticholesteremic Agents
  • Pravastatin