本帖最後由 goodcat1111 於 2009-8-18 23:51 編輯
作者：Yael Waknine
出處：WebMD醫學新聞
August 3, 2009 — 美國食品藥物管理局(FDA)核准每天一次的saxagliptin錠劑(Onglyza，Bristol-Myers Squibb公司，與AztraZeneca Pharmaceuticals，LP藥廠聯合行銷)，與飲食及運動控制同時用於控制第2型糖尿病患的高血糖。
這項二肽基酶-4抑制劑的作用為刺激胰臟在餐後製造更多胰島素。
FDA藥物評估與研究中心、代謝與內分泌產品小組主任Mary Parks醫師在新聞稿中指出，對於美國2,400萬糖尿病患來說，維持血糖的良好控制是相當重要的。血糖過高會導致視力模糊、多尿，最後會導致腎臟與眼睛病變等嚴重狀況。
FDA的此項核准主要是根據8篇臨床試驗資料，結果顯示，saxagliptin在降低第2型糖尿病患之HbA1c、空腹血糖、飯後血糖等方面優於安慰劑。同樣的，將saxagliptin併用metformin、硫醯基尿素類(sulfonylurea)藥物或thiazolidinedione，降低的HbA1c值大於單用任何一種藥物。
根據新聞稿，saxagliptin對低風險病患來說，不會增加心血管事件風險。計畫進行上市後研究，以評估該藥對於較高風險者如重症者或年長者的心血管安全性。
FDA Approves Saxagliptin for Improving Glycemic Control in Diabetic Patients
By Yael Waknine
Medscape Medical News
August 3, 2009 — The US Food and Drug Administration (FDA) has approved once-daily saxagliptin tablets (Onglyza, Bristol-Myers Squibb Co, marketed in conjunction with AztraZeneca Pharmaceuticals, LP) for use with diet and exercise to control hyperglycemia in patients with type 2 diabetes mellitus.
The dipeptidyl peptidase-4 inhibitor works by stimulating the pancreas to make more insulin after a meal.
"Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes," said Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research in an agency news release. "High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease."
The FDA's action was primarily based on data from 8 clinical trials. Results showed that saxagliptin was superior to placebo for reducing HbA1c levels, fasting plasma glucose, and postprandial glucose levels in patients with type 2 diabetes mellitus. Likewise, adding saxagliptin to metformin, a sulfonylurea, or a thiazolidinedione lowered HbA1c levels to a greater extent than either of these standard drugs alone.
According to the news release, saxagliptin was not associated with an increased risk for cardiovascular events in low-risk patients. A postmarketing study is planned to evaluate the drug's cardiovascular safety in a higher-risk population that includes sicker and older patients. |
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