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[i]Due to the importance of this study, we received two commentaries, one published last week, and the current one.[/i]

 

Culver and colleagues [1] recently analyzed the use of statins and the risk of diabetes mellitus in postmenopausal women who participated in the Women’s Health Initiative (WHI) observational study. This investigation included 153,840 women without diabetes mellitus and no missing data at baseline (age 50–79 years, recruited at 40 clinical centers across the United States during 1993–1998, with follow-up until 2005). At baseline, 7% reported taking statin medication. There were 10,242 incident cases of new-onset, self-reported diabetes mellitus over 1,004,466 person-years of follow-up. An increased risk of 71% for diabetes mellitus in the postmenopausal women taking any statin was recorded, when users were compared to non-users. Multivariate adjustments for confounders still showed an increased risk of 48%. The investigators concluded that this may be a medication class effect, which undoubtedly is both statistically and clinically significant. Soon after the publication of these results, in February 2012, the Food and Drug Administration (FDA) announced that several changes to the label of statins became effective, indicating that incident diabetes mellitus and increased blood glucose are possible outcomes of statin use and that usually minor and reversible cognitive side-effects may occur as well. Interestingly, the FDA said it is also eliminating the recommendation that patients on statins undergo routine periodic monitoring of liver enzymes, because this approach is ineffective in detecting and preventing the ‘rare and unpredictable’ serious liver injuries related to statins [2].

Author(s)

  • Enrique Sánchez-Delgado
    Internal Medicine-Clinical Pharmacology, Vice President of ANCYM, Hospital Metropolitano Vivian Pellas, Managua, Nicarágua

Citations

  1. Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Womens Health Initiative. Arch Intern Med 2012;172:144-52.
    http://www.ncbi.nlm.nih.gov/pubmed/22231607
  2. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs.
    http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
  3. Preiss D, Seshasai SR, Welsh P, et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA 2011;305:2556-64.
    http://www.ncbi.nlm.nih.gov/pubmed/21693744
  4. Preiss D, Sattar N. Statins and the risk of new-onset diabetes: a review of recent evidence. Curr Opin Lipidol 2011;22:460-6.
    http://www.ncbi.nlm.nih.gov/pubmed/21897230
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