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薬理と治療
Abstract
[Hypertriglyceridemia has been recognized as an independent risk factor for atherosclerosis. Increased plasma remnant lipoproteins which are atherogenic underlies hyeprtriglyceridemia. Dyslipidemia in type 2 diabetic patients is characterized by increased plasma triglyceride(TG), remnant lipoproteins and LDL. The correction of increased plasma levels of both TG and LDL is very important to prevent atherosclerosis in type 2 diabetic patients. Fibrate decreases mainly plasma TG and remnant lipoproteins, whereas statin decreases mainly plasma LDL. The combination therapy of fibrate and statin is therefore thought to be very effective for the correction, but little information is available in Japan. In this study we investigated the effect of the combination therapy on dyslipidemia, glycemic control and adverse reactions in diabetic patients with typeIIb hyperlipidemia(hypercholesterolemia plus hypertriglyceridemia).Seventeen type 2 diabetic patients without coronary artery disease were studied. They were under 65 years old. They had typeIIb hyperlipidemia, i. e. increased plasma levels of LDL−cholesterol(≧120 mg/dL)and TG(≧150 mg/dL). They had normal renal function (plasma creatinine level<1.1 mg/dL)and normal liver function. Plasma lipds and remnant cholesterol were measured before and after the treatment. Plasma remnant cholesterol was determined as RLP−cholesterol(normal range<5.2 mg/dL)by the method of Nakajima et al.The combination therapy of half dose fibrate(bezafibrate 200 mg/day after breakfast)and low dose statin(pitavastatin 1 mg/day after supper)over 6 months significantly reduced plasma TG by 54.6%(251→113 mg/dL), plasma LDL−cholesterol by 26.4%(147→108 mg/dL), and plasma remnant cholesterol by 61.9%(10.5→4.0 mg/dL), and raised plasma HDL−cholesterol by 15.2%(46→53 mg/dL). The combination therapy tended to reduce HbA1c(5.9→5.6%), but this difference was not statistically different. Plasma CPK and creatinine levels were not changed before and after the treatment, and no adverse reactions were observed over the study period. It is concluded that the combination therapy of half dose bezafibrate and low dose pitavastatin is very effective to reduce particularly plasma TG and remnant cholesterol as well as plasma LDL−cholesterol in diabetic patients. The combination therapy should be positively considered in diabetic patients who have both hypertriglyceridemia and hypercholesterolemia if they have normal renal function.(Jpn Pharmacol Ther 2008;36:317−23) KEY WORDS Pitavastatin, Bezafibrate, Combination therapy, Hypercholesterolemia, Hypertriglyceridemia, Type 2 diabetic patients, Effectiveness, Safety, Hypertriglyceridemia has been recognized as an independent risk factor for atherosclerosis. Increased plasma remnant lipoproteins which are atherogenic underlies hyeprtriglyceridemia. Dyslipidemia in type 2 diabetic patients is characterized by increased plasma triglyceride(TG), remnant lipoproteins and LDL. The correction of increased plasma levels of both TG and LDL is very important to prevent atherosclerosis in type 2 diabetic patients. Fibrate decreases mainly plasma TG and remnant lipoproteins, whereas statin decreases mainly plasma LDL. The combination therapy of fibrate and statin is therefore thought to be very effective for the correction, but little information is available in Japan. In this study we investigated the effect of the combination therapy on dyslipidemia, glycemic control and adverse reactions in diabetic patients with typeIIb hyperlipidemia(hypercholesterolemia plus hypertriglyceridemia).Seventeen type 2 diabetic patients without coronary artery disease were studied. They were under 65 years old. They had typeIIb hyperlipidemia, i. e. increased plasma levels of LDL−cholesterol(≧120 mg/dL)and TG(≧150 mg/dL). They had normal renal function (plasma creatinine level<1.1 mg/dL)and normal liver function. Plasma lipds and remnant cholesterol were measured before and after the treatment. Plasma remnant cholesterol was determined as RLP−cholesterol(normal range<5.2 mg/dL)by the method of Nakajima et al.The combination therapy of half dose fibrate(bezafibrate 200 mg/day after breakfast)and low dose statin(pitavastatin 1 mg/day after supper)over 6 months significantly reduced plasma TG by 54.6%(251→113 mg/dL), plasma LDL−cholesterol by 26.4%(147→108 mg/dL), and plasma remnant cholesterol by 61.9%(10.5→4.0 mg/dL), and raised plasma HDL−cholesterol by 15.2%(46→53 mg/dL). The combination therapy tended to reduce HbA1c(5.9→5.6%), but this difference was not statistically different. Plasma CPK and creatinine levels were not changed before and after the treatment, and no adverse reactions were observed over the study period. It is concluded that the combination therapy of half dose bezafibrate and low dose pitavastatin is very effective to reduce particularly plasma TG and remnant cholesterol as well as plasma LDL−cholesterol in diabetic patients. The combination therapy should be positively considered in diabetic patients who have both hypertriglyceridemia and hypercholesterolemia if they have normal renal function.(Jpn Pharmacol Ther 2008;36:317−23) KEY WORDS Pitavastatin, Bezafibrate, Combination therapy, Hypercholesterolemia, Hypertriglyceridemia, Type 2 diabetic patients, Effectiveness, Safety]
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