Austen J L, Shifrin F A, Bartucci M R, Knauss T C, Schulak J A, Hricik D E
School of Medicine, Case Western Reserve University, Cleveland, OH, USA.
Ann Pharmacother. 1996 Dec;30(12):1386-9. doi: 10.1177/106002809603001204.
To assess the efficacy and safety of fluvastatin in hypercholesterolemic, cyclosporine-treated, renal transplant recipients, and to determine whether concomitant steroid therapy in such patients alters the lipid-lowering effects of fluvastatin.
An open-label, prospective, parallel study was performed in 20 cyclosporine-treated renal transplant recipients with hypercholesterolemia defined by a low-density lipoprotein (LDL) concentration greater than 160 mg/dL or a total cholesterol/high-density lipoprotein (HDL) concentration ratio greater than 5.0. Lipid profiles were measured before and 1 month after treatment with fluvastatin 20 mg/d. Lipid profiles in a group of patients receiving concomitant therapy with prednisone (n = 12) were compared with those of patients who had not received steroids for at least 6 months (n = 8).
The Renal Transplant Clinic at University Hospitals of Cleveland.
The main outcome measures were serum concentrations of total cholesterol, LDL, HDL, and triglycerides. Treatment failure was defined by LDL concentrations persistently above 160 mg/dL after 1 month of fluvastatin therapy. Safety was assessed clinically and by serial measurements of liver enzymes and creatine phosphokinase.
LDL concentrations decreased significantly in both the steroid-treated and steroid-free groups after 1 month of fluvastatin therapy. There was no significant change in HDL concentrations or serum triglycerides in either group. Treatment failure was more common in patients receiving steroids (4/12 patients) than in steroid-free patients (1/8 patients). After 1 month of therapy, LDL cholesterol was significantly lower in the steroid-free group (126 +/- 18 mg/dL) than in the steroid-treated group (147 +/- 23 mg/dL) (p < 0.05). There was no clinical or laboratory evidence of myonecrosis in either group.
Low dosages of fluvastatin appear to be safe in cyclosporine-treated renal transplant recipients. Steroid-free patients exhibit a response to fluvastatin that is qualitatively similar to that of steroid-treated patients, consisting of a significant decrease in LDL concentrations and no change in HDL or serum triglyceride concentrations.
评估氟伐他汀对接受环孢素治疗的高胆固醇血症肾移植受者的疗效和安全性，并确定此类患者同时接受类固醇治疗是否会改变氟伐他汀的降脂效果。
对20名接受环孢素治疗的肾移植受者进行了一项开放标签、前瞻性、平行研究，这些患者患有高胆固醇血症，定义为低密度脂蛋白（LDL）浓度大于160mg/dL或总胆固醇/高密度脂蛋白（HDL）浓度比大于5.0。在接受20mg/d氟伐他汀治疗前及治疗1个月后测量血脂谱。将一组接受泼尼松联合治疗的患者（n = 12）的血脂谱与至少6个月未接受类固醇治疗的患者（n = 8）的血脂谱进行比较。
克利夫兰大学医院的肾移植诊所。
主要观察指标为血清总胆固醇、LDL、HDL和甘油三酯浓度。治疗失败定义为氟伐他汀治疗1个月后LDL浓度持续高于160mg/dL。通过临床评估以及连续测量肝酶和肌酸磷酸激酶来评估安全性。
氟伐他汀治疗1个月后，类固醇治疗组和未使用类固醇组的LDL浓度均显著降低。两组的HDL浓度或血清甘油三酯均无显著变化。接受类固醇治疗的患者（4/12例）治疗失败比未使用类固醇的患者（1/8例）更常见。治疗1个月后，未使用类固醇组的LDL胆固醇（126±18mg/dL）显著低于使用类固醇治疗组（147±23mg/dL）（p<0.05）。两组均无临床或实验室证据表明存在肌坏死。
低剂量氟伐他汀在接受环孢素治疗的肾移植受者中似乎是安全的。未使用类固醇的患者对氟伐他汀的反应在性质上与使用类固醇治疗的患者相似，表现为LDL浓度显著降低，而HDL或血清甘油三酯浓度无变化。
