高脂血症に対するニセリトロール, プラバスタチン併用効果の検討

Abstract

We examined the efficacy of combined therapy of a nicotinic acid derivative, niceritrol, and an HMG-CoA reductase inhibitor, pravastatin, for patients with hyperlipidemia.The subjects were 22 patients with hyperlipidemia who were randomly divided into 2 groups. One group (N group) received 750 to 1, 500mg/day niceritrol (t. i. d.) during the first 8 weeks and then 5 to 10mg/day pravastatin (s. i. d.) was added for 8 weeks. In the other group (P group), 5 to 10mg/day pravastain (s. i. d.) was given for the first 8 weeks, and then 750 to 1, 500mg/day niceritrol (t. i. d.) was added to the regimen for the next 8 weeks. Patients whose serum total cholesterol (TC) level decreased to less than 200mg/dl at 8 weeks with the single therapy did not receive the combined therapy.The decrease in TC after the single therapy was 4.1% in the N group and 8.2% in the P group, and the combined therapy further decreased its levels by about 11% in both groups. Its decrease from the baseline was 15% in the N group and 17.8% in the P group. The combined therapy successfully controlled the TC level to less than 200mg/dl in 8 of 22 cases (36.4%). Regarding triglycerides (TG), the level decreased by 36.0% in the N group and increased by 3.6% in the P group after 8 weeks of the single therapy, and changed by +22.6% in the N group and -26.9% in the P group after the combined therapy. The total decrease from the baseline was 30.1% and 26.3%, respectively. The change in HDL cholesterol was +21.5% in the N group and -3.8% in the P group after the single therapy, and the combined therapy resulted in increases of 4.0% and 15.6%, respectively. The total change of HDL from the baseline was +25.0% in the N group and +10.0% in the P group. The Lp (a) level in the N group changed by -14% at 8 weeks, by +4.8% after the combined therapy, and finally by -12.0% compared with the baseline. The Lp (a) level of the group changed by -1.9%, -24.5% and -28.3%, respectively.These results confirmed that the combined therapy of niceritrol and pravastatin markedly improved the serum levels of lipid and lipoprotein. Furthermore, as no severer side effects were observed, this combined therapy is useful for clinical therapy