關於tinzaparin sodium(Innohep®)和促性腺激素釋放激素激動劑(GnRH agonists)安全性的最新資訊 Latest safety updates on tinzaparin sodium(Innohep®) and Gonadotropin-Releasing Hormone (GnRH) agonists

  • 腎功能受損的年老病人使用tinzaparin sodium(Innohep®)死亡風險增加

    近期一份臨床研究(IRIS study)的中期安全性分析報告指出, 相對於使用大份子肝素(UFH)的病人, 使用Innohep®的病人之死亡率可能增加, 該項研究因此而被暫停。該研究是使用治療劑量的Innohep®於腎功能受損的急性靜脈血栓性栓塞(VTE)的年老病人。因此, 藥物監測暨管理處建議醫生﹑藥劑師及其他衛生專業人士:

1. 不應使用Innohep®於70歲以上及腎功能受損的年老病人。

2.  對於中至重度腎功能受損的病人, 須謹慎使用Innohep®。對所有腎功能受損的病人, 如使用該藥, 須對病人進行密切監測

 

 

  • 前列腺癌病人使用促性腺激素釋放激素激動劑(GnRH agonists)可能增加糖尿病及心血管疾病的風險

    藥物事務廳於本年5月曾發出傳真, 指美國食物及藥物管理局(USFDA)正評估使用促性腺激素釋放激素激動劑(GnRH agonists)的安全性。USFDA在評估相關數據後, 表示男性前列腺癌病人使用GnRH激動劑可能增加出現糖尿病及心血管疾病的風險, 當中包括心臟病發﹑突然死亡以及中風。雖然引致糖尿病及心血管疾病的風險看似輕微, 然而評估當中的風險是重要的, 因此建議醫生及其他衛生專業人士:

1.     於開始處方GnRH激動劑於前列腺癌病人前, 評估病人的糖尿病及心血管疾病的風險;

2.     相對其他治療前列腺癌的合適方案, 時刻審慎評估使用GnRH激動劑的效益及風險;

3.     定期監測使用GnRH激動劑的病人的血糖及其糖化血紅蛋白;

4.     監測病人有否出現心血管疾病的症狀;

5.     依據現行臨床實踐規範, 監控病人心血管方面的危險因子, 如吸煙﹑高血壓﹑高膽固醇﹑高血糖以及體重過高。

 

備註獲准在本澳市場供應的促性腺激素釋放激素激動劑(GnRH agonists)包括goserelin (Zoladex®), triptorelin (Decapeptyl®, Diphereline®), buserelin (Suprefact®) and leuprolein (Enantrone®)。

                                                                                                                                                                                                                                                                                      

  • Use of tinzaparin(Innohep®) in elderly with renal impairment increases mortality

An interim safety analysis of a clinical study(IRIS study) revealed an increase in all-cause mortality in patients who received Innohep® compared to the unfractionated heparin(UFH) and this study was halted. This study involved the use of therapeutic doses of Innohep® for then treatment of acute venous thromboembolism(VTE) in elderly patients with renal impairment. Hence, Division Pharmacovigilance and Pharmacoeconomics(DFF) recommends physicians, pharmacists and other healthcare professionals:

1.     Innohep® is not recommended in elderly patients over 70 years of age with renal impriment.

2.     Innohep® should be used with caution in patients with moderate to severe renal impairment; in all cases of impaired renal function, patients should be closely monitored.

 

  • Gonadotropin Releasing Hormones(GnRH) agonists for prostate cancer may possibly increase the risks of developing diabetes and certain cardiovascular diseases

DAF issued a safety alert about gonadotropin releasing hormones(GnRH) agonists in May stating that United States Food and Drug Administration (USFDA) was evaluating that class of drugs. After reviewing relevant data, USFDA indicated that the GnRH agonists used in prostate cancer in men may possibly increase the exposed patients’ risks of developing diabetes and certain cardiovascular diseases namely heart attack, sudden cardiac death, stroke in men. Although the risk for diabetes and cardiovascular diseases appears to be low, it is important for healthcare professionals to evaluate patients for risk factors for these diseases.  The following information are recommended for prescribers and other healthcare professionals:

1.   evaluate patients for risk factors on diabetes and certain CV diseases before initiating any GnRH treatment for their prostate cancers;

2.   always carefully weigh the known benefits against the risks of using GnRH agonists upon any appropriate treatment for prostate cancer;

3.   monitor blood glucose and/or glycosylated hemoglobin periodically in patients receiving GnRH agonists;

4.   monitor patients for signs and symptoms suggestive of development of cardiovascular disease;

5.   ensure that cardiovascular risk factors such as cigarette smoking, high blood pressure, high cholesterol, high blood sugar, and being overweight are managed according to current clinical practice.

 

Note:The Gonadotropin-Releasing Hormone(GnRH) agonists authorized for distribution in the Macao market include goserelin (Zoladex®), triptorelin (Decapeptyl®, Diphereline®), buserelin (Suprefact®) and leuprolein (Enantrone®).

  

參考資料/References and websites:

https://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/innohep_hpc-cps-eng.php

https://www.fda.gov/Drugs/DrugSafety/ucm229986.htm


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