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The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials

BMJ 2009; 338 doi: (Published 30 June 2009) Cite this as: BMJ 2009;338:b2376
  1. J J Brugts, doctor1,
  2. T Yetgin, doctor1,
  3. S E Hoeks, epidemiologist1,
  4. A M Gotto, professor, doctor2,
  5. J Shepherd, professor, doctor3,
  6. R G J Westendorp, professor, doctor4,
  7. A J M de Craen, epidemiologist4,
  8. R H Knopp, professor, doctor5,
  9. H Nakamura, professor, doctor6,
  10. P Ridker, professor, doctor7,
  11. R van Domburg, epidemiologist1,
  12. J W Deckers, doctor1
  1. 1Department of Cardiology, Erasmus MC Thoraxcenter, 3015 GD, Rotterdam, Netherlands
  2. 2Weill Medical College of Cornell University, NY, USA
  3. 3University of Glasgow, Scotland
  4. 4Department of Gerontology and Geriatrics, Leiden University Medical Center, Netherlands
  5. 5Department of Medicine and Northwest Lipid Research Clinic, WA, USA
  6. 6Mitsukoshi Health and Welfare Foundation, Tokyo, Japan
  7. 7Brigham and Women’s Hospital, Boston, MA, USA
  1. Correspondence to: J J Brugts j.brugts{at}
  • Accepted 4 February 2009


Objectives To investigate whether statins reduce all cause mortality and major coronary and cerebrovascular events in people without established cardiovascular disease but with cardiovascular risk factors, and whether these effects are similar in men and women, in young and older (>65 years) people, and in people with diabetes mellitus.

Design Meta-analysis of randomised trials.

Data sources Cochrane controlled trials register, Embase, and Medline.

Data abstraction Two independent investigators identified studies on the clinical effects of statins compared with a placebo or control group and with follow-up of at least one year, at least 80% or more participants without established cardiovascular disease, and outcome data on mortality and major cardiovascular disease events. Heterogeneity was assessed using the Q and I2 statistics. Publication bias was assessed by visual examination of funnel plots and the Egger regression test.

Results 10 trials enrolled a total of 70 388 people, of whom 23 681 (34%) were women and 16 078 (23%) had diabetes mellitus. Mean follow-up was 4.1 years. Treatment with statins significantly reduced the risk of all cause mortality (odds ratio 0.88, 95% confidence interval 0.81 to 0.96), major coronary events (0.70, 0.61 to0.81), and major cerebrovascular events (0.81, 0.71 to 0.93). No evidence of an increased risk of cancer was observed. There was no significant heterogeneity of the treatment effect in clinical subgroups.

Conclusion In patients without established cardiovascular disease but with cardiovascular risk factors, statin use was associated with significantly improved survival and large reductions in the risk of major cardiovascular events.


  • Contributors: All authors contributed to data collection and writing the manuscript. RvD and JWD are guarantors.

  • Funding: None.

  • Competing interests: AMG is a consultant for Genentech, Kowa, Martek, Merck, and Merck/Schering-Plough, and serves on the board of directors for Aegerion and Arisaph. He is a member of DuPont’s health advisory board and serves on the data safety monitoring board for Novartis. JS carried out consultancy work and receives support for research from Bristol-Myers Squibb. RGJW receives support for research from Bristol-Myers Squibb. HN has received travel grants and speaking honorariums from Sankyo. RHK has received research fees and speaking honorariums from Pfizer. PR has received research grant support from the National Heart Lung and Blood Institute, the National Cancer Institute, the Donald W Reynolds Foundation, the Leducq Foundation, Astra-Zeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; consulting fees and lecture fees from Astra-Zeneca, Novartis, Merck-Schering Plough, Sanofi-Aventis, ISIS, and Vascular Biogenics; and is listed as a co-inventor on patents held by the Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease. These patents have been licensed to Siemens and Astra-Zeneca.

  • Ethical approval: Not required.

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