A. Tanaka et al., A double-blind trial on the effects of atorvastatin on glycemic control inJapanese diabetic patients with hypercholesterolemia, CLIN CHIM A, 312(1-2), 2001, pp. 41-47
A double-blind, placebo-control led, parallel-group study was performed to
determine whether atorvastatin, a new HMG-CoA reductase inhibitor, could ef
fectively and safely reduce plasma LDL-cholesterol concentrations in Japane
se patients with type-2 diabetes without influencing glycemic control. The
subjects were patients with hypercholesterolemia (serum cholesterol concent
ration;greater than or equal to 5.7 mmol/l (220 mg/dl)) and stable glycemic
control. The fasting concentrations of hemoglobin A(1C) (HbA(1C)), fructos
amine, and 1,5-anhydroglucitol (1,5-AG) were-measured as indices of glycemi
c control, Plasma lipid concentrations and the safety of the drug were also
examined. Forty eligible patients in two groups of 20 each were administer
ed atorvastatin (10 mg/day) or placebo. Neither atorvastatin nor placebo ca
used a significant change in HbA(1C), fructosainine, or 1,5-AG concentratio
ns. Atorvastatin significantly reduced total cholesterol mad LDL-cholestero
l concentrations from baseline by 29.7% (p < 0.0001) and 41.6% (1) < 0.0001
), respectively. The incidence of clinical adverse events and that of abnor
mal changes in laboratory test values did not differ between the two groups
. In this trial, atorvastatin effectively and safely reduced LDL-cholestero
l concentrations in diabetic patients with hypercholesterolemia without inf
luencing glycemic control. These findings are clinically important because
there are many diabetic patients with hypercholesterolemia and such patient
s have a high risk of developing arteriosclerotic disease. (C) 2001 Elsevie
r Science B.V. All rights reserved.