Jacobson T A, Chin M M, Fromell G J, Jokubaitis L A, Amorosa L F
Department of Medicine, Emory University School of Medicine, Atlanta, Georgia 30303.
Am J Cardiol. 1994 Jul 15;74(2):149-54. doi: 10.1016/0002-9149(94)90088-4.
Seventy-four patients with plasma low-density lipoprotein cholesterol levels > or = 160 mg/dl after an American Heart Association phase 1 diet were randomized to double-blind treatment with fluvastatin, 20 mg/day, or placebo for 6 weeks. Immediate-release niacin was then added to both treatment regimens and titrated to a maximum of 3 g/day for a further 9 weeks. After 6 weeks of fluvastatin monotherapy, low-density lipoprotein cholesterol levels decreased by 21% (p < 0.001 vs placebo), and after the addition of niacin, response was potentiated to 40% compared with 25% for the niacin control group at study end point (p < 0.001). Fluvastatin, alone and in combination with niacin, also significantly improved high-density lipoprotein cholesterol (increases of about 30%) and triglyceride profiles (decreases of approximately 28%) from baseline. Lipoprotein(a) decreased by 37% in those receiving fluvastatin-niacin but was unaltered in those receiving fluvastatin alone. No serious adverse events were ascribed to fluvastatin, and no cases of myositis were observed. Small, transient, asymptomatic increases in aspartate aminotransferase were noted with fluvastatin-niacin treatment but were not considered clinically relevant. Although the fluvastatin-niacin combination in this study was without evidence of significant transaminitis, myopathy, or rhabdomyolysis, it would seem prudent to continue to monitor its safety with longer term use. In conclusion, fluvastatin, both as monotherapy and in combination with niacin, proved to be an effective, safe, and well-tolerated therapeutic alternative for hypercholesterolemia.
74例在采用美国心脏协会1期饮食后血浆低密度脂蛋白胆固醇水平≥160mg/dl的患者，被随机分为两组，分别接受每日20mg氟伐他汀或安慰剂的双盲治疗，为期6周。之后，两种治疗方案均添加速释烟酸，并将剂量滴定至最大每日3g，持续9周。氟伐他汀单药治疗6周后，低密度脂蛋白胆固醇水平下降了21%（与安慰剂相比，p<0.001），添加烟酸后，反应增强至40%，而烟酸对照组在研究终点时为25%（p<0.001）。氟伐他汀单独使用以及与烟酸联合使用时，与基线相比，还显著改善了高密度脂蛋白胆固醇水平（升高约30%）和甘油三酯水平（降低约28%）。接受氟伐他汀-烟酸联合治疗的患者脂蛋白(a)下降了37%，而仅接受氟伐他汀治疗的患者则无变化。未发现严重不良事件归因于氟伐他汀，也未观察到肌炎病例。氟伐他汀-烟酸治疗时，观察到天冬氨酸转氨酶有小幅度、短暂、无症状的升高，但未被认为具有临床相关性。尽管本研究中氟伐他汀-烟酸联合治疗未显示出明显的转氨酶升高、肌病或横纹肌溶解的证据，但长期使用时继续监测其安全性似乎是谨慎的做法。总之，氟伐他汀无论是单药治疗还是与烟酸联合使用，都被证明是治疗高胆固醇血症的一种有效、安全且耐受性良好的治疗选择。
