美國食物及藥物管理局(USFDA)正評估兩項臨床試驗(ROADMAP和ORIENT), 數據顯示, 相對於使用安慰劑的病人,服用高血壓藥物olmesartan的第II型糖尿病患者, 出現與心血管相關死亡的比率較高。因此, USFDA對醫生﹑藥劑師和其他衛生專業人士提供下列資訊：
- 到目前為止, 並未得出olmesartan會增加死亡風險的結論。
- 對於高血壓病人, 相信olmesartan的效益仍然高於其潛在的風險。
- 現有評估olmesartan及其他血管緊張素II受體阻斷劑的臨床試驗並沒有提及該等藥物會增加與心血管相關的死亡率。
- 醫生應按照藥物的說明書適當地處方olmesartan。
United States Food and Drug Administration(USFDA) is evaluating data from two clinical trials(ROADMAP and ORIENT) in which patients with type 2 diabetes taking the blood pressure medication, olmesartan had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. Therefore, USFDA offers the following information for the physicians, pharmacists and other healthcare professionals:
- Until now, it has not been concluded that olmesartan increases the risk of death.
- It is believed the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.
- Other controlled clinical trials evaluating olmesartan and other angiotensin II receptor blockers have not suggested an increased risk of cardiovascular-related death.
- Physicians should follow the recommendations in the drug label when prescribing olmesartan.
參考資料/Reference and website：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215249.htm
https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm215222.htm