Jokubaitis L A, Knopp R H, Frohlich J
Northwest Lipid Research Clinic, University of Washington, Seattle.
J Intern Med Suppl. 1994;736:103-7.
In this preliminary report of a 20-week trial, 66 patients with non-insulin-dependent diabetes mellitus (NIDDM) and hyperlipidaemia who remained eligible after an 8-week dietary stabilization phase were randomly allocated to receive 20 mg of fluvastatin or placebo once daily for 6 weeks. Fluvastatin was subsequently increased to 20 mg twice daily and administered according to the same schedule, versus placebo, for a further 6 weeks. Both dosages of fluvastatin substantially improved serum lipid profiles compared with baseline and placebo. Both dosages of fluvastatin significantly reduced low-density- and very-low-density-lipoprotein (LDL, VLDL), cholesterol and triglyceride (TG) compared with placebo, and both dosages significantly elevated high-density-lipoprotein (HDL) cholesterol. The ratio of LDL to HDL was also significantly decreased. Amongst the 58 patients who completed the study, there was no evidence either of myopathy or of hepatotoxicity; mean creatine kinase values remained stable in the fluvastatin arm. Fasting glucose, glycosylated haemoglobin, and fructosamine levels were not markedly affected by active treatment. No serious adverse events attributable to the drug were reported. In conclusion, both dosages of fluvastatin appear to be effective and safe in the management of hyperlipidaemia in this outpatient, maturity-onset, diabetic population.
在这份关于一项为期20周试验的初步报告中，66例非胰岛素依赖型糖尿病（NIDDM）和高脂血症患者在经过8周的饮食稳定期后仍符合条件，被随机分配，每天一次接受20毫克氟伐他汀或安慰剂，为期6周。随后，氟伐他汀剂量增至每天两次，每次20毫克，并按照相同方案与安慰剂对照，再给药6周。与基线水平和安慰剂相比，氟伐他汀的两种剂量均显著改善了血脂谱。与安慰剂相比，氟伐他汀的两种剂量均显著降低了低密度脂蛋白和极低密度脂蛋白（LDL、VLDL）、胆固醇和甘油三酯（TG），且两种剂量均显著提高了高密度脂蛋白（HDL）胆固醇水平。LDL与HDL的比值也显著降低。在完成研究的58例患者中，没有证据表明存在肌病或肝毒性；在氟伐他汀组，肌酸激酶的平均数值保持稳定。空腹血糖、糖化血红蛋白和果糖胺水平未受到积极治疗的显著影响。未报告任何可归因于该药物的严重不良事件。总之，在这个门诊就诊的成年发病型糖尿病患者群体中，氟伐他汀的两种剂量在治疗高脂血症方面似乎都是有效且安全的。
