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Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics
AUDIENCE: Cardiology, Pharmacy, Family Practice, Endocrinology
ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.
BACKGROUND: FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.
RECOMMENDATION: Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. Recommendations for use of olmesartan remain the same, but FDA will require information about some of the studies to be included in the drug labels.
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA完成一項與olmesartan相關之安全性回顧，目前無明顯證據證實糖尿病病人服用olmesartan會增加心血管風險。FDA認為olmesartan用於治療高血壓仍利大於弊。
背景：
由於ROADMAP試驗之結果，FDA進行安全性回顧。此試驗研究目的為探討第二型糖尿病病人使用olmesartan是否可延緩腎臟損害，卻發現相較於安慰組，服用olmesartan發生心血管相關之死亡風險增加，然而非致死性心臟病發之風險卻較安慰組低。
建議：
病人在尚未與醫療人員討論之前，勿自行停止服用olmesartan或任何降血壓藥品，FDA未更改對於olmesartan之使用建議，FDA將把此訊息更新於藥品仿單中。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1881期）
