Clinical Question: Is atorvastatin effective in the primary prevention of cardiovascular disease in adults with diabetes mellitus?

Setting: Outpatient (any)

Study Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: Researchers enrolled 2,838 men and women 40 to 75 years of age with type 2 diabetes mellitus of at least six months’ duration who also had hypertension, retinopathy, microalbuminuria, macroalbuminuria, or current tobacco use. Patients were assigned randomly (concealed allocation) to receive atorvastatin in a dosage of 10 mg daily (n = 1,428) or placebo (n = 1,410), regardless of lipid levels. The main outcome, determined by intention to treat, was a composite of first acute coronary event, coronary revascularization, or stroke. The study ended two years early because the predetermined threshold for the primary outcome was reached. By the time the study was terminated, patients had been evaluated for approximately 3.9 years.

During the study, 5.8 percent of patients taking atorvastatin experienced the composite end point compared with 9 percent of those taking placebo (number needed to treat = 32 for 3.9 years; 95 percent confidence interval, 20 to 79). However, no significant differences were noted in the individual outcomes of all-cause mortality or in the need for coronary revascularization. The authors state that there is no justification for using a threshold level of low-density lipoprotein cholesterol to determine which patients with type 2 diabetes should receive statins. This statement seems to be premature. Using their data, only 3 percent of patients would benefit after 3.9 years. Individual risk assessment and tailored intervention make more sense.

Bottom Line: In high-risk patients with diabetes, atorvastatin delays the development of acute coronary events but does not significantly decrease the rate of revascularization or all-cause mortality. (Level of Evidence: 1b)