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Bromocriptine mesylate: Food and Drug Administration approved new approach in therapy of non-insulin dependant diabetes mellitus with poor glycemic control

机译:甲磺酸溴隐亭:美国食品药品监督管理局批准了一种新的方法来治疗血糖控制不佳的非胰岛素依赖型糖尿病

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摘要

Food and Drug Administration (FDA) approved bromocriptine mesylate, a quick release formulation, 0.8 mg tablets, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Bromocriptine products were previously approved by the FDA for the treatment of pituitary tumors and Parkinson's disease. Bromocriptine is thought to act on circadian neuronal activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma glucose, triglyceride, and free fatty acid levels in fasting and postprandial states in insulin-resistant patients. Adverse events most commonly reported in clinical trials of bromocriptine included nausea, fatigue, vomiting, headache, and dizziness. These events lasted a median of 14 days and were more likely to occur during initial titration of the drug. Due to novel mechanism of action, single daily dose, and lower incidence of stroke, myocardial infarction and vascular events, bromocriptine may act as landmark in treatment of type 2 diabetes.
机译:美国食品药品监督管理局(FDA)批准了甲磺酸溴隐亭(速溶制剂)0.8毫克片剂作为饮食和运动的辅助手段,以改善2型糖尿病成年人的血糖控制。溴隐亭产品先前已获得FDA批准用于垂体瘤和帕金森氏病的治疗。人们认为溴隐亭在下丘脑内的昼夜节律神经元活动中起作用,以重置异常升高的下丘脑驱动力,从而在胰岛素抵抗患者的禁食和餐后状态下增加血浆葡萄糖,甘油三酸酯和游离脂肪酸的水平。溴隐亭临床试验中最常报告的不良事件包括恶心,疲劳,呕吐,头痛和头晕。这些事件持续了14天的中位数,并且更有可能在药物的初始滴定过程中发生。由于新颖的作用机制,单日剂量和较低的中风,心肌梗塞和血管事件发生率,溴隐亭可能成为2型糖尿病治疗的里程碑。

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    Keche, Yogendra;

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  • 年度 2010
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  • 原文格式 PDF
  • 正文语种 en
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