TY - JOUR
T1 - 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
AU - Berkplanken, I.
AU - Hoogerbrugge, N.
AU - Jansen, H.
AU - Princen, H. M. G.
AU - Huisman, M. V.
AU - van de Ree, M. A.
AU - Stolk, R. P.
AU - van Venrooij, F. V.
AU - Banga, J. D.
AU - Dallinga-Thie, G.
PY - 2001
Y1 - 2001
N2 - 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 dyslipidermia (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 ran, domized 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 mig 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
AB - 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 dyslipidermia (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 ran, domized 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 mig 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
M3 - Article
SN - 0149-5992
VL - 24
SP - 1335
EP - 1341
JO - Diabetes Care
JF - Diabetes Care
IS - 8
ER -