Originally published as JCO Early Release 10.1200/JCO.2006.06.3560 on September 25 2006

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Statins and Cancer Risk: A Literature-Based Meta-Analysis and Meta-Regression Analysis of 35 Randomized Controlled Trials

Stefanos Bonovas, Kalitsa Filioussi, Nikolaos Tsavaris, Nikolaos M. Sitaras

From the Departments of Pharmacology and Pathophysiology, School of Medicine, University of Athens; and the Department of Epidemiological Surveillance & Intervention, Hellenic Center for Disease Control & Prevention, Athens, Greece

Address reprint requests to Stefanos Bonovas, MD, MSc, Department of Pharmacology, School of Medicine, University of Athens, 75 Mikras Asias Str, Athens 11527, Greece; e-mail: sbonovas{at}med.uoa.gr

PURPOSE: A growing body of literature suggests that statins may have chemopreventive potential against cancer. Our aim was to examine the strength of this association through a detailed meta-analysis and meta-regression analysis of randomized controlled trials (RCTs).

METHODS: A comprehensive search for trials published up to 2005 was performed, reviews of each study were conducted, and data were abstracted. Before meta-analysis, the studies were evaluated for publication bias and heterogeneity. Pooled relative risk (RR) estimates and 95% CIs were calculated using the random- and fixed-effects models. Subgroup, sensitivity, and meta-regression analyses were also conducted.

RESULTS: Thirty-five RCTs of statins for cardiovascular outcomes contributed to the analysis (n = 109,143). The degree of variability between trials was consistent with what would be expected to occur by chance alone. Statin use was not associated with a substantially increased or decreased overall risk of cancer (RR = 0.99; 95% CI, 0.94 to 1.04). Similarly, statin use did not significantly affect respiratory cancer risk (RR = 0.95; 95% CI, 0.83 to 1.09). However, the meta-regression analysis indicated that age of study participants modified the association between statin use and cancer risk (P = .003).

CONCLUSION: Our findings do not support a protective effect of statins against cancer. However, this conclusion is limited by the relatively short follow-up periods (4.5 years on average) of the studies analyzed. Thus, it is important to continue monitoring the long-term safety profiles of statins. Until then, physicians need to be vigilant in ensuring that statin use remains restricted to the approved indications.

published online ahead of print at www.jco.org on September 25, 2006.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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