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It is well established that statin therapy significantly reduces the risk of vascular events. With multiple statins available on the market, researchers have been prompted to compare intensive-dose to moderate-dose statin therapy. In 2010, the Cholesterol Treatment Trialists’ published data supporting the use of intensive statin therapy, citing a 15% greater reduction in major vascular events including coronary death or non-fatal myocardial infarction, coronary revascularization, and ischemic stroke.1 While researching the benefits of intensive statin therapy, results have suggested that statins may be associated with an increased risk of diabetes. This association prompted a meta-analysis by Sattar and colleagues2 who found a 9% increased risk for the development of diabetes mellitus (DM) in patients taking statins as compared to placebo. Their analysis concluded a number needed to harm (NNH) of 225 for the development of one additional case of diabetes mellitus after four years of statin treatment.2

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To further investigate the association between statins and risk of diabetes, Preiss and colleagues conducted a meta-analysis to examine the relationship between intensive-dose statin therapy as compared to moderate-dose statin therapy on the risk of developing diabetes.3 The investigators searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for large randomized controlled trials published between January 1, 1996, and March 31, 2011. Trials were considered eligible if they included 1000 or more study participants on statin therapy, had a mean follow-up period of at least 1 year, and had identical follow-up durations in both arms of treatment. At the conclusion of the literary review, 5 trials were incorporated in the meta-analysis: the Treating to New Targets (TNT) trial, the Aggrastat to Zocor (A to Z) trial, the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) trial, the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction (PROVE IT-TIMI 22) trial, and the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). The primary endpoint for the meta-analysis was the development of DM. This included  patients who were diagnosed with diabetes, patients started on glucose-lowering medications, or patients who exhibited  two fasting blood glucose values of >126mg/dL while participating in the study. The secondary endpoint was a composite of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary artery bypass surgery, percutaneous coronary intervention, and all-cause mortality).3

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Throughout the mean follow-up of 4.9 years, 1449 participants receiving intensive-dose statin therapy developed new-onset DM, as compared to 1300 individuals receiving moderate-dose statin therapy (OR 1.12, 95% CI 1.04-1.22). The NNH for the development of diabetes with the intensive statin therapy was 498 after 1 year of treatment. Secondary outcomes confirmed fewer cardiovascular events with intensive-dose statin therapy compared to moderate-dose statin therapy (3134 vs 3550; OR 0.84, 95% CI 0.75-0.94). The number needed to treat (NNT) to prevent one cardiovascular event with the use of intensive-dose statin therapy was 155 after 1 year of treatment. Trials using simvastatin 80mg did not demonstrate significant cardiovascular benefit when compared to moderate-dose statin therapy (OR 0.95, 95% CI 0.88-1.03), ...

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