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

  1. The Diabetes Atorvastatin Lipid Intervention (DALI) Study Group

    Abstract

    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.

    Footnotes

    • Address correspondence and reprint requests to R.P. Stolk, MD, PhD, Julius Center for Patient Oriented Research, University Medical Center Utrecht, D01.335, P.O. Box 85500, 3508 GA Utrecht, the Netherlands. E-mail: r.p.stolk{at}jc.azu.nl.

      Received for publication 16 January 2001 and accepted in revised form 17 April 2001.

      A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

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