Járai Z, Kapocsi J, Farsang C, Detki K, Pados G, Sebestyén Z, Holló J
Fövárosi Onkormányzat Szent Imre Kórház I. Belgyógyászati Osztály.
Orv Hetil. 1996 Aug 25;137(34):1857-9.
The efficacy and safety of the HMG-CoA reductase fluvastatin was investigated in a multicenter, open label clinical therapeutic trial in the treatment of hypercholesterinaemia in hypertensive patients (WHO I-II.). 49 patients were involved, 6 patients were dropped out because of th lack of compliance, 43 patients were investigated (mean age: 57.6 +/- 9.4 years, mean blood pressure: 146 +/- 16/88+/- g mmHg (systolic/diastolic). The antihypertensive treatment was unchanged during the study. An 8 weeks low-lipid diet was started if the fasting total cholesterol (TC) level was equal or higher than 6.5 mM/L and the triglyceride level was lower than 4.6 mM/L. After the dietary period fluvastatin treatment was started (20 mg o.d.), if the level of LDL-C was higher than 4,1 mM/L. Blood pressure, heart rate, TC, HDL-C (HDL2-C, HDL3-C), apoA1, apoB, TG were measured at the 4th, 8th, 12th weeks of treatment. LDL-C was calculated with Fridewald equation. The daily dose of fluvastatin was increased to 40 mg, if LDL-C level was higher than 3.5 mM/L after 4 weeks of treatment. 36 patients completed the study (Group B). 7 patients were dropped out at the end of the dietary period, because of the significant decrease of TC and LDL-C levels (Group A). In Group B fluvastatin significantly reduced the level of TC (from 7.22 +/- 0.88 to 5.99 +/- 0.98 mM/L), of LDL-C (from 5.13 +/- 0.71 to 3.95 +/- 0.88 mM/L), and the level of ApoB (from 0.97 +/- 0.26 to 0.85 +/- 0.15 mM/L), but did not influence significantly the level of HDL-C, ApoA1 and TG. The diastolic blood pressure decreased significantly during the dietary period, while after beginning the fluvastatin treatment the decrease of the systolic blood pressure became significant. There was no change in the heart rate. Only minor side effects were observed in 3 patients (dysuria, constipation, lack of appetite). Fluvastatin proved to be an effective and well-tolerated drug in the treatment of hypercholesterinaemia in hypertensive patients.
在一项多中心、开放标签的临床治疗试验中，研究了HMG-CoA还原酶抑制剂氟伐他汀治疗高血压患者高胆固醇血症（WHO I-II级）的疗效和安全性。共有49例患者参与，6例因依从性差退出研究，43例患者接受调查（平均年龄：57.6±9.4岁，平均血压：146±16/88±9 mmHg（收缩压/舒张压）。研究期间抗高血压治疗不变。如果空腹总胆固醇（TC）水平等于或高于6.5 mM/L且甘油三酯水平低于4.6 mM/L，则开始为期8周的低脂饮食。饮食期结束后，如果低密度脂蛋白胆固醇（LDL-C）水平高于4.1 mM/L，则开始氟伐他汀治疗（每日20 mg）。在治疗的第4、8、12周测量血压、心率、TC、高密度脂蛋白胆固醇（HDL-C，HDL2-C，HDL3-C）、载脂蛋白A1、载脂蛋白B、甘油三酯。LDL-C采用弗里德瓦尔德方程计算。如果治疗4周后LDL-C水平高于3.5 mM/L，则将氟伐他汀的每日剂量增加至40 mg。36例患者完成研究（B组）。7例患者在饮食期结束时退出，原因是TC和LDL-C水平显著下降（A组）。在B组中，氟伐他汀显著降低了TC水平（从7.22±0.88降至5.99±0.98 mM/L）、LDL-C水平（从5.13±0.71降至3.95±0.88 mM/L）以及载脂蛋白B水平（从0.97±0.26降至0.85±0.15 mM/L），但对HDL-C、载脂蛋白A1和甘油三酯水平没有显著影响。饮食期间舒张压显著下降，而开始氟伐他汀治疗后收缩压下降显著。心率无变化。仅3例患者出现轻微副作用（排尿困难、便秘、食欲不振）。氟伐他汀被证明是治疗高血压患者高胆固醇血症的一种有效且耐受性良好的药物。
