The effect of aggressive versus standard lipid lowering by atorvastatin on diabetic dyslipidemia: the DALI study: a double-blind, randomized, placebo-controlled trial in patients with type 2 diabetes and diabetic dyslipidemia

Objective: In patients with type 2 diabetes, intensive glucose regulation, although effective for microangiopathy, has not been shown to have unambiguous preventive effects on the occurrence of Cardiovascular Disease. Patients with diabetes show a characteristic dyslipidemia (high triglyceride level, low HDL Cholesterol level). Aggressive reduction of triglycerides might be an effective method to reduce the cardiovascular risk in these patients.

Research design and methods: A double-blind, placebo-controlled, randomized study to assess the effect of 30 weeks of administration of atorvastatin 10 and 80 mg on plasma triglyceride levels in 217 patients with type 2 diabetes and fasting triglyceride levels between 1.5 and 6.0 mmol/l.

Results: Administration of atorvastatin 10 and 80 mg resulted in significant reductions (25 and 35%, respectively) of plasma triglyceride levels (both P < 0.001). The difference between 10 and 80 mg was not statistically significant (P > 0.5). Atorvastatin 10 mg provided significant reductions from baseline in total Cholesterol (-30%, P < 0.001), LDL Cholesterol (-40%, P < 0.001), and Apolipoprotein B (-31%, P < 0.001), and significantly increased HDL Cholesterol from baseline by 6% (P < 0.005). Atorvastatin 80 mg had a similar effect on HDL Cholesterol (+5.2%, P < 0.005) but significantly decreased total Cholesterol (-40%, P < 0.001), LDL Cholesterol (-52%, P < 0.001), and Apolipoprotein B (-40%, P < 0.001) more than atorvastatin 10 mg (P < 0.005). The side effects of atorvastatin 10 and 80 mg were similar and did not differ from the patients receiving placebo.

Conclusions: Administration of 10- and 80-mg doses of atorvastatin provides similar, significant reductions from baseline in triglyceride levels in patients with type 2 diabetes. A higher dose of atorvastatin improves cholesterol-related parameters. Both doses were well tolerated in this patient population.