Long-term Efficacy and Safety of Atorvastatin in Dyslipidemic Patients Undergoing Continuous Ambulatory Peritoneal Dialysis

Elias V. Balaskas, Athanasios Sioulis, Eva Patrikalou, Haralampos Kampouris, Achilleas Tourkantonis

Objective: Lipid abnormalities are common in patients on continuous ambulatory peritoneal dialysis (CAPD) and they are risk factors for atherosclerosis. In this prospective uncontrolled study, the aim was to evaluate the efficacy and safety of atorvastatin, a new statin, in hypercholesterolemic CAPD patients with or without hypertriglyceridemia who failed to respond to diet control.

Methods: Following a hypolipidemic diet for 2 months, atorvastatin was administered at a dose of 10 mg/day once daily in 24 patients (14 males, 10 females). Mean age was 59.9 years (range, 19-74 years) and average time on CAPD was 16.6 months (range, 4-52 months). The results were evaluated at 0, 1, 3, 6, 12, 18, 24, 30, 36, 42, and 48 months. A total of three patients received atorvastatin for longer than 48 months, eight patients received it for longer than 42 months, 10 patients for longer than 36 months, 17 patients for longer than 24 months, 20 patients for longer than 18 months, and all (24) patients for longer than 12 months.

Results: Highly significant decreases were noted in total cholesterol (from 282 ± 28 to 178± 22 mg/dL, 20-50%, mean, 34%; p < 0.001), low-density lipoprotein cholesterol (from 198 ± 25 to 112 ± 20 mg/dL, 21-53%, mean, 37%; p < 0.001), and triglycerides (from 256 ± 116 to 177 ± 40 mg/dL, 12-45%, mean, 28%, p < 0.01) from the sixth month. High-density lipoprotein cholesterol was significantly increased from the sixth month (from 40 ± 9 to 48 ± 9 mg/dL, 11-28%, mean, 19.4%; p < 0.01). These changes remained steady during the study. No liver function abnormalities were observed and serum creatinine kinase levels remained within normal limits during treatment. No complications or other side effects were detected.

Conclusions: Our data indicate that atorvastatin, even at a low dose of 10 mg/day, is an effective, safe, and well-tolerated drug for the long-term treatment of hyperlipidemia in CAPD patients. [Hong Kong J Nephrol 2003;5(2):78-83]

Key words: atorvastatin, CAPD, chronic renal disease, dyslipidemia, HDL-cholesterol, hypercholesterolemia, hypertriglyceridemia, LDL-cholesterol

目的: 對於正在接受連續可活動性腹膜透析 (CAPD) 的病人，血脂異常 - 動脈粥狀硬化的危險因子 - 是常見的問題。本研究以前瞻、非對照方式，對一種新的statin藥物 - atorvastatin的功效及安全性作出調查，其對象為患有高膽固醇血症(部分亦合併有高三酸甘油脂血症)的CAPD接受者，均對飲食控制缺乏反應。

方法: 在經過兩個月的低脂飲食後，病人 (n = 24, 14男10女) 開始接受atorvastatin一天一次10 mg治療。病人的平均年齡為59.9歲(範圍19-74歲)，平均接受CAPD達16.6個月(4-52個月)。療效的評估於治療開始前、及後1、3、6、12、18、24、30、36、42、與48個月進行。所有病人均持續接受治療達12個月以上，達18個月以上者有20人，24個月以上有17人，36個月以上有10人，42個月以上有8人，達48個月以上者則有3人。

結果: 從第6個月開始，各血脂指標均已出現高度顯著的下降，包括總膽固醇(從282 ± 28至178 ± 22 mg/dL, 20-50%, 平均34%; p < 0.001)、低密度脂蛋白膽固醇 (從198 ± 25至112 ± 20 mg/dL, 21-53%, 平均37%; p < 0.001)、及三酸甘油脂(從 256 ± 116至177± 40 mg/dL, 12-45%, 平均28%; p < 0.01)﹔同一期間，高密度脂蛋白膽固醇則出現顯著的上升(從40 ± 9至48 ± 9 mg/dL, 11-28%, 平均19.4%; p < 0.01)。這些變化在研究期間均維持穩定。治療期間，病人的肝功能及血清creatinine kinase濃度均保持正常，亦不曾發生任何併發症或其他副作用。

結論: 本研究發現，即使在低劑量 (10 mg/day) 下，atorvastatin對CAPD病人的長期血脂控制既安全又有效。

Back to Previous Page