藥物警訊

Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk

AUDIENCE: Cardiology, Endocrinology, Pharmacy

ISSUE: FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. FDAs request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March 2014, after which FDA will conduct a thorough analysis and report findings publicly.

At this time, FDA considers information from the NEJM study to be preliminary. Analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.

BACKGROUND: Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.

RECOMMENDATION: Patients should not stop taking saxagliptin and should speak with their health care professionals about any questions or concerns. Health care professionals should continue to follow the prescribing recommendations in the drug labels.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

近期一篇saxagliptin可能與心衰竭有關之研究發表於New England Journal of Medicine (NEJM)，此篇研究發現心臟功能不佳的病人，服用saxagliptin後心衰竭住院機率較服用安慰劑增加，但未發現死亡率或其他主要心血管風險（如心臟病發或中風等機率）的增加。FDA已要求廠商提供相關資料以進行進一步調查。FDA目前尚未確立saxagliptin與心血管疾病風險之相關性。

背景

Saxagliptin為一種配合飲食及運動來控制第二型糖尿病病人血糖之藥物。此作用為增加用餐後體內胰島素之分泌量。

建議

醫療專業人員應持續追蹤藥品仿單上之處方建議。正服用此藥之病人在未經醫療專業人員指示下不應自行停藥，如有任何問題，請與醫療人員聯絡。

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