Intervention Review

Statins and fibrates for preventing melanoma

  1. Robert Dellavalle1,*,
  2. Amanda Drake2,
  3. Marla Graber3,
  4. Lauren Heilig4,
  5. Eric Hester5,
  6. Kathryn Johnson5,
  7. Kristie McNealy5,
  8. Lisa Schilling6

Editorial Group: Cochrane Skin Group

Published Online: 21 JAN 2009

Assessed as up-to-date: 14 AUG 2005

DOI: 10.1002/14651858.CD003697.pub2

Database Title

Additional Information

How to Cite

Dellavalle R, Drake A, Graber M, Heilig L, Hester E, Johnson K, McNealy K, Schilling L. Statins and fibrates for preventing melanoma. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD003697. DOI: 10.1002/14651858.CD003697.pub2.

Author Information

  1. 1

    University of Colorado Denver, School of Medicine, Department of Dermatology, Denver, Colorado, USA

  2. 2

    UCHSC, Dermatology, Denver, Colorado, USA

  3. 3

    University of Colorado Health Sciences Cente, Denver, CO, USA

  4. 4

    University of Colorado Health Sciences Center, Department of Dermatology, Denver, Colorado, USA

  5. 5

    University of Colorado Health Sciences Center, Denver, Colorado, USA

  6. 6

    University of Colorado Denver School of Medicine, Denver, Colorado, USA

*Robert Dellavalle, Department of Dermatology, University of Colorado Denver, School of Medicine, Denver VA Medical Center, 155 Clermont St. #165, Denver, Colorado, 80220, USA. robert.dellavalle@uchsc.edu.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 JAN 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Effective treatment for advanced melanoma is lacking. While no drug therapy currently exists for prevention of melanoma, in vitro, case-control, and animal model evidence suggest that lipid-lowering medications, commonly taken for high cholesterol, might prevent melanoma.

Objectives

To assess the effects of statin or fibrate lipid-lowering medications on melanoma outcomes.

Search methods

We searched the Cochrane Skin Group Specialised Register (February 2003), CENTRAL (The Cochrane Library Issue 1, 2005), MEDLINE (to March 2003), EMBASE (to September 2003), CANCERLIT (to October 2002), Web of Science (to May 2003), and reference lists of articles. We approached study investigators and pharmaceutical companies for additional information (published or unpublished studies).

Selection criteria

Trials involving random allocation of study participants, where experimental groups used statins or fibrates and participants were enrolled for at least four years of therapy.

Data collection and analysis

Three authors screened 109 abstracts of articles with titles of possible relevance. We then thoroughly examined the full text of 72 potentially relevant articles. We requested unpublished melanoma outcomes data from the corresponding author of each qualifying trial.

Main results

We identified 16 qualifying randomised controlled trials (RCTs) (7 statin, 9 fibrate). Thirteen of these trials (involving 62,197 participants) provided data on incident melanomas (6 statin, 7 fibrate). A total of 66 melanomas were reported in groups receiving the experimental drug and 86 in groups receiving placebo or other control therapies. For statin trials this translated to an odds ratio of 0.90 (95% confidence interval 0.56 to 1.44) and for fibrate trials an odds ratio of 0.58 (95% confidence interval 0.19 to 1.82).

Subgroup analyses failed to show statistically significant differences in melanoma outcomes by gender, melanoma occurrence after two years of participation in trial, stage or histology, or trial funding. Subgroup analysis by type of fibrate or statin also failed to show statistically significant differences, except for the statin subgroup analysis which showed reduced melanoma incidence for lovastatin, based on one trial only (odds ratio 0.52, 95% confidence interval 0.27 to 0.99).

Authors' conclusions

The melanoma outcomes data collected in this review of RCTs of statins and fibrates does not exclude the possibility that these drugs prevent melanoma. There was a 10% and 42% reduction for participants on statins and fibrates, respectively, however these results were not statistically significant. Until further evidence is established, limiting exposure to ultraviolet radiation remains the most effective way to reduce the risk of melanoma.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Currently there is no clear evidence that cholesterol drugs reduce melanoma risk.

Some studies have suggested that medicines (such as statins and fibrates) taken to lower blood cholesterol may reduce the risk of melanoma skin cancer. Our review of 16 studies did not find any clear evidence to support such a suggestion, but we cannot exclude a useful effect of such drugs until more studies become available.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

司他汀類藥物(statins) 及纖維酸衍生物 (fibrates) 對於黑色素瘤的預防

對於後期的黑色素瘤目前並沒有有效的治療。目前也沒有已知的藥物可以預防黑色素瘤。但是，在體外實驗、病例對照、及動物模式內的研究，暗示以往用來降低膽固醇的降血脂藥物，可能預防黑色素瘤的發生。

目標

評估司他汀類藥物及纖維酸衍生藥物等降血脂藥物對於黑色素瘤的預後影響。

搜尋策略

我們尋找了Cochrane Skin Group Specialised Register (2003年二月), CENTRAL (The Cochrane Library Issue 1, 2005), MEDLINE (至2003三月), EMBASE (至2003九月), CANCERLIT (至2002十月), Web of Science (至2003五月), 以及其相關文獻。我們同時也訪問了研究員以及藥廠詢問進一步的資訊，包括已發表及未發表的研究。

選擇標準

試驗必需是隨機分配參與者，並且實驗組必需使用司他汀類藥物及纖維酸衍生藥物至少四年以上。

資料收集與分析

三名作者瀏覽了109篇標題有相關性的摘要。接著完整閱讀72篇可能相關的全文。我們同時也向相關文獻的作者索取了未公開的黑色素瘤的預後資料。

主要結論

一共16篇隨機對照試驗 (7篇司他汀類藥物及9篇纖維酸衍生藥物) 被收錄。其中13篇提供了黑色素瘤的發生率資料 (共62197參與者，6篇司他汀類藥物及7篇纖維酸衍生藥物) 。一共66個黑色素瘤患者在使用藥物的實驗組中被發現，而另有86名患者在安慰劑組中被發現.對司他汀類藥物勝算比 (odds ratio) 為0.90 (95% 信賴區間0.56 to 1.44) 。纖維酸衍生藥物勝算比0.58 (95% 信賴區間0.19 to 1.82). 子族群分析並不能在性別、服用兩年期的藥物、腫瘤分期，組織學、或試驗資金來源上，發現黑色素瘤的發生機率有統計上顯著差異。至於以司他汀類藥物及纖維酸衍生藥物的比較分組分析也不能找到差異，除了在一個試驗中司他汀類藥物子族群分析當中，lovastatin降低了黑色素瘤的發生率，勝算比0.52 (95% 信賴區間0.27到 0.99)

作者結論

在司他汀類藥物及纖維酸衍生藥物的隨機對照試驗的回顧文章中，關於黑色素瘤預後的資料，並不能排除這些藥物預防黑色素瘤的可能性。仍然有10% 及42% 的發生率降低分別在司他汀類藥物及纖維酸衍生藥物中發現，雖然並未達到統計上的顯著意義。在進一步的證據被證實前，預防紫外線的曝曬仍然是最重要預防黑色素瘤的方式。

翻譯人

本摘要由馬偕醫院謝志偉翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

目前沒有明確的證據證實降血脂藥物可以降低黑色素瘤發生的危險，雖然有些報告宣稱降血脂藥物 (如司他汀類藥物及纖維酸衍生藥物) 有這樣的效果。但我們對16篇文章的回顧並不支持這樣的結果。不過在進一步的研究前，我們也不能完全排除這些藥物的有效性。

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