Insulin glargine潛在地與癌症風險增加有關


  July 1, 2009 — 根據美國食品藥物管理局(FDA)表示,四項觀察性研究中的三項結果顯示,使用insulin glargine(Lantus,賽諾菲安萬特)與癌症風險增加有關,但這些研究發現需要更長的追蹤研究來確認這之間的關係。
  
  根據FDA的安全性資訊與不良反應通報系統,MedWatch今天發布的一項警訊,FDA目前正在收集許多有關使用insulin glargine的安全性數據,包括這些新發表的觀察性研究。
  
  FDA目前建議病患不應該在沒有諮詢健康照護專業人員就停止使用insulin glargine。目前並沒有給健康照護專業人員採取行動的指引發佈。
  
  Insulin glargine被核准使用於第一型與第二型糖尿病病患控制血糖。
  
  這些觀察性研究發表於6月30日的糖尿病期刊,這是歐洲糖尿病研究學會(EASD)官方期刊。根據EASD的新聞稿,一項收集127,000位接受胰島素治療病患的數據分析,相較於類似劑量的人類胰島素,使用insulin glargine與癌症風險增加有關。在那些使用insulin glargine的病患中,每100位接受人類胰島素病患,會增加1位病患罹癌。
  
  這項於德國進行的研究,也顯示癌症風險增加與劑量有關;10 U的insulin glargine增加癌症風險9%,而50 U的增加風險31%。
  
  由於這些發現,這些研究也針對瑞典、蘇格蘭以及英國的資料庫進行研究。瑞典的研究發現,相較於接受其他劑型胰島素的病患,接受insulin glargine的病患們,發生乳癌的風險高出2倍。蘇格蘭研究發現乳癌風險並未顯著增加,然而,英國研究發現insulin glargine與任何種類的癌症之間並沒有關係。
  
  根據FDA表示,許多研究正在進行中,可以進一步地了解是否有任何癌症風險,與使用insulin glargine有關。
  
  更多的資訊可以在FDA的MedWatch網站上找到。
  
  與使用insulin glargine有關的不良反應都應該與FDA的MedWatch通報系統聯繫,電話為1-800-FDA-1088或傳真到1-800-FDA-0178,線上網站在http://www.fda.gov/medwatch或是郵寄到5600 Fishers Lane, Rockville, Maryland 20852-9787。
  

Insulin Glargine Potentially Associated With Increased Cancer Risk

By Emma Hitt, PhD
Medscape Medical News

July 1, 2009 — Three of 4 observational studies suggest an increased risk for cancer associated with use of insulin glargine (Lantus, sanofi-aventis), although these findings warrant further follow-up studies to confirm an association, according to the United States Food and Drug Administration (FDA).

The FDA is currently reviewing many sources of safety data for insulin glargine, including these newly published observational studies, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

The FDA currently is recommending that patients not stop taking insulin glargine without consulting a healthcare professional. No guidance regarding action to be taken by healthcare professionals has been issued.

Insulin glargine is approved to control blood glucose in patients with type 1 and type 2 diabetes.

The observational studies were published in the June 30 issue of Diabetologia,, the journal of the European Association for the Study of Diabetes (EASD). According to an EASD press release, one data analysis of 127,000 insulin-treated patients reported a statistically significant link between cancer and insulin glargine use compared with those using similar doses of human insulin. Among those receiving insulin glargine, there was an increase of 1 person with cancer for every 100 people receiving human insulin.

This study, conducted in Germany, also indicated a dose-dependent increase in cancer risk; 10 U of insulin glargine increased the risk by 9% whereas 50 U increased the risk by 31%.

As a result of these findings, studies were also conducted in databases from Sweden, Scotland, and the United Kingdom. The Swedish study found that compared with patients on other forms of insulin, patients receiving insulin glargine alone had a 2-fold increased risk for breast cancer. The Scottish study found a nonsignificant increased risk for breast cancer, whereas the UK study found no link between insulin glargine and any type of cancer.

According to the FDA, further studies are underway “to better understand the risk, if any, for cancer associated with use of [insulin glargine].”

More information is available on the FDA's MedWatch Web site.

Adverse events related to use of insulin glargine therapy should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

    
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