Intervention Review
HMG CoA reductase inhibitors (statins) for dialysis patients
Editorial Group: Cochrane Renal Group
Published Online: 8 JUL 2009
Assessed as up-to-date: 20 JUL 2008
DOI: 10.1002/14651858.CD004289.pub4
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Database Title
Additional Information
How to Cite
Navaneethan SD, Nigwekar SU, Perkovic V, Johnson DW, Craig JC, Strippoli GFM. HMG CoA reductase inhibitors (statins) for dialysis patients. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD004289. DOI: 10.1002/14651858.CD004289.pub4.
Publication History
- Publication Status: Edited (conclusions changed)
- Published Online: 8 JUL 2009
Abstract
Background
Cardiovascular disease accounts for more than half the number of deaths among dialysis patients. The role of HMG CoA reductase inhibitors (statins) in the treatment of dyslipidaemia in dialysis patients is unclear and their safety has not been established.
Objectives
To assess the benefits and harms of statins in peritoneal dialysis (PD) and haemodialysis patients (HD).
Search methods
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled trials (CENTRAL, in The Cochrane Library), the Cochrane Renal Group's specialised register and handsearched reference lists of textbooks, articles and scientific proceedings.
Selection criteria
Randomised controlled trials (RCTs) and quasi-RCTs comparing statins with placebo, no treatment or other hypolipidaemic agents in dialysis patients.
Data collection and analysis
Two authors independently assessed study quality and extracted data. Statistical analyses were performed using the random effects model after testing for heterogeneity. The results were expressed as mean difference (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI).
Main results
Fourteen studies (2086 patients) compared statins versus placebo or other lipid lowering agents. Compared to placebo, statins did not decrease all-cause mortality (10 studies, 1884 patients; RR 0.95, 95% CI 0.86 to 1.06) or cardiovascular mortality (9 studies, 1839 patients: RR 0.96, 95% CI 0.65 to 1.40). There was a lower incidence of nonfatal cardiovascular events with statins compared to placebo in haemodialysis patients (1 study, 1255 patients; RR 0.86, 95% CI 0.74 to 0.99). Compared with placebo, statin use was associated with a significantly lower end of treatment average total cholesterol (14 studies, 1823 patients; MD -42.61 mg/dL, 95% CI -53.38 to -31.84), LDL cholesterol (13 studies, 1801 patients; MD -43.06 mg/dL, 95% CI -53.78 to -32.35) and triglycerides (14 studies, 1823 patients: MD -24.01 mg/dL, 95% CI -47.29 to -0.72). There was similar occurrence of rhabdomyolysis and elevated liver function tests with statins in comparison to placebo.
Authors' conclusions
Statins decreased cholesterol levels in dialysis patients similar to that of the general population. With the exception of one study, studies were of short duration and therefore the efficacy of statins in decreasing the mortality rate is still unclear. Statins appear to be safe in this high-risk population. Ongoing studies should provide more insight about the efficacy of statins in reducing mortality rates in dialysis patients.
Plain language summary
Statins reduce total cholesterol and triglycerides in dialysis patients to a level similar to that seen in the general population
Dialysis patients are at high risk of heart disease. Statins have been shown to decrease cholesterol levels and mortality in the general population. We aimed to determine if a similar effect has been established in dialysis patients. This review identified 14 studies - 13 comparing statins with placebo and one comparing statins to another lipid lowering agent. Statins decreased cholesterol levels to a level similar to that seen in the general population and were safe. One large study did not find any major mortality benefits with statins even though it reduced the number of cardiovascular events in dialysis patients.
摘要
背景
透析患者HMG CoA 還原酉每抑制劑的使用
心血管疾病佔所有透析患者死亡原因的一半以上。而statins的角色在治療高血脂症的洗腎病患，其療效及安全性仍不清楚。
目標
評估使用statins於腹膜透析和血液透析患者的好處和壞處。
搜尋策略
檢索MEDLINE、EMBASE、CENTRAL等資料庫和Cochrane 腎臟組的專門登記記錄以及人工搜尋教科書的參考書目，文章和科學記錄。
選擇標準
隨機對照試驗和半隨機對照試驗，比較statins、安慰劑、沒有治療或是使用其他類的降血脂藥物在透析患者上。
資料收集與分析
兩位作者獨立評估試驗的品質和分析數據。分別以連續結果和二分結果的隨機效應模型，估計出平均差和相對危險度在95% 的信賴區間裡。
主要結論
共有十四個研究 (2086位患者) ，被拿來比較statins、安慰劑或是使用其他類的降血脂藥物。結果發現statins比起安慰劑，在總致死率 (10個研究，共1884位患者，RR 0.95, 95% CI 0.86 to 1.06) 以及心血管死亡率 (9個研究，共1839位患者，RR 0.96, 95% CI 0.65 to 1.40) 都沒有降低的效果。不過在非致死性的心血管意外，statins比起安慰劑在血液透析病患的發生率有輕微的降低 (1個研究，共1225位患者，RR 0.86, 95% CI 0.74 to 0.99) 。另外，statin比上安慰劑，在總膽固醇 (14個研究，共1823位患者，MD −42.61 mg/dL, 95% CI −53.38 to −31.84) 、低密度膽固醇 (13個研究，共1801位患者; MD −43.06 mg/dL, 95% CI −53.78 to −32.35) 和三酸甘油脂 (14個研究，共1823位患者; MD −24.01 mg/dL, 95% CI −47.29 to −0.72) 皆有明顯降低的效果。至於橫紋肌溶解症和肝功能指數上升的副作用，statins和安慰劑無明顯差異。
作者結論
Statins降低透析患者膽固醇的效果類似於一般人。除了一個研究以外，其餘的研究時間都太短暫，因此statins是否可以降低死亡率，仍未確定。不過，statins的使用在透析患者上是安全的。或許目前正在進行的研究，將來可以提供我們更多有關statins降低死亡率的證據。
翻譯人
本摘要由馬偕醫院李俊賢翻譯。
此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。
總結
透析患者有較高的心臟疾病風險。Statins能夠降低膽固醇和一般人的死亡率。我們研究的目標放在透析患者是否也會有同樣的效果。這篇綜論共包括14個研究，其中13個研究比較了statins和安慰劑，另1個研究則在比較statins和其他類的降血脂藥物。結果發現statins降低透析患者膽固醇的效果和安全性類似於一般人。一個大型的研究結果發現，statins的治療對於透析患者雖然可以降低心血管意外的發生，但是在死亡率上statins並沒有較好的優勢。