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DANIEL M. RICHE, PHARM.D., BCPS, is Assistant Professor, Department of Pharmacy Practice, School of Pharmacy; and KATIE S. MCCLENDON, PHARM.D., BCPS, is Clinical Assistant Professor, Department of Pharmacy Practice, School of Pharmacy, University of Mississippi, Jackson.

Address correspondence to Dr. Riche at the Department of Pharmacy Practice, School of Pharmacy, University of Mississippi, 2500 North State Street, Office Annex Building, WW128, Jackson, MS 39216 (driche{at}sop.umsmed.edu).

Purpose. The major statin trials that included a significant number of patients with diabetes without preexisting coronary heart disease (CHD) are reviewed and evaluated, and the role statins should play in primary prevention is discussed. Summary. Cardiovascular (CV) disease risk is increased in patients with type 2 diabetes mellitus, and diabetes is considered a CHD risk equivalent in current treatment guidelines. The American Diabetes Association (ADA) guidelines recommend statin therapy in the majority of patients with diabetes. Four large studies (which included a significant number of patients with diabetes and no history of CHD) have affected treatment guidelines, despite various flaws in their designs and some nonsignificant results. The most recent trial evaluating the primary prevention of CHD in diabetes patients (the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus [ASPEN]) has been published since these guidelines. ASPEN found that in patients with diabetes at lower CHD risk, atorvastatin 10 mg was not superior to placebo in reducing time to the first major CV event or procedure. The nonsignificant results of ASPEN may be because of the moderate reduction in low-density-lipoprotein cholesterol, or it may be that patients with type 2 diabetes mellitus and no additional CV risk factors do not benefit significantly from statin therapy. Conclusion. Current ADA recommendations may be too aggressive as available evidence suggests that the decision to initiate pharmacotherapy with a statin in patients with type 2 diabetes mellitus who do not have preexisting CHD should be individualized rather than based solely on the diagnosis of type 2 diabetes mellitus. Index terms: American Diabetes Association; Antilipemic agents; Atorvastatin; Cardiovascular diseases; Diabetes mellitus; Protocols

 

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