Vol 3, No 3 (2002): Practical Diabetology
Other materials agreed with the Editors
Published online: 2002-09-24
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
Diabetologia Praktyczna 2002;3(3):157-166.
Abstract
INTRODUCTION. 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.
MATERIAL AND METHODS. A double-blind, placebocontrolled, 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.
MATERIAL AND METHODS. A double-blind, placebocontrolled, 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.
Keywords: DALI Study Groupdiabetic dyslipidaemiaatorvastatin