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Statins and prevention of infections: systematic review and meta-analysis of data from large randomised placebo controlled trials

BMJ 2011; 343 doi: (Published 29 November 2011) Cite this as: BMJ 2011;343:d7281
  1. Hester L van den Hoek, graduate student13,
  2. Willem Jan W Bos, internist2,
  3. Anthonius de Boer, professor of pharmacotherapy1,
  4. Ewoudt M W van de Garde, clinical pharmacist and epidemiologist13
  1. 1Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, Netherlands
  2. 2Department of Internal Medicine, St Antonius Hospital, Nieuwegein, Netherlands
  3. 3Department of Clinical Pharmacy, St Antonius Hospital, Koekoekslaan 1, PO Box 2500, 3430 EM, Nieuwegein, Netherlands
  1. Correspondence to: E M W van de Garde{at}
  • Accepted 3 October 2011


Objective To evaluate whether the potential of statins to lower the risk of infections as published in observational studies is causal.

Design Systematic review and meta-analysis of randomised placebo controlled trials.

Data sources Medline, Embase, and the Cochrane Library.

Study selection Randomised placebo controlled trials of statins (up to 10 March 2011) enrolling a minimum of 100 participants, with follow-up for at least one year.

Data extraction Infection or infection related death.

Results The first study selection yielded 632 trials. After screening of the corresponding abstracts and full text papers, 11 trials totalling 30 947 participants were included. 4655 of the participants (2368 assigned to statins and 2287 assigned to placebo) reported an infection during treatment. Meta-analysis showed no effect of statins on the risk of infections (relative risk 1.00, 95% confidence interval 0.96 to 1.05) or on infection related deaths (0.97, 0.83 to 1.13).

Conclusion These findings do not support the hypothesis that statins reduce the risk of infections. Absence of any evidence for a beneficial effect in large placebo controlled trials reduces the likelihood of a causal effect as reported in observational studies.


  • Contributors: EMWvdG conceived and designed the study. HLvdH acquired the data, carried out the statistical analysis, and drafted the manuscript. HLvdH had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis and is the guarantor. All authors were involved in interpretation of results and drafting and revising the manuscript. All authors approved the final submitted version.

  • Funding: No funding sources had a role in the study design, data collection, data analysis, data interpretation, or writing of the report.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at (available on request from the corresponding author) and declare: no support from any company for the submitted work; WB had relationships with AstraZeneca and Merck/Schering Plough, for participation in the AURORA (A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events) trial and the SHARP (Study of Heart and Renal Protection) trial, respectively, in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: Not required.

  • Data sharing: No additional data available.

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