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Pharmacokinetic and Pharmacodynamic Properties of a Novel Inhaled Insulin

机译:新型吸入胰岛素的药代动力学和药效学特性

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摘要

Advances in insulin treatment options over recent decades have markedly improved the management of diabetes. Despite this, glycemic control remains suboptimal in many people with diabetes. Although postprandial glucose control has been improved with the development of subcutaneously injected rapid-acting insulin analogs, currently available insulins are not able to fully mimic the physiological time–action profile of endogenously secreted insulin after a meal. The delayed onset of metabolic action and prolonged period of effect induce the risk of postprandial hyperglycemia and late postprandial hypoglycemia. A number of alternative routes of insulin administration have been investigated over time in an attempt to overcome the limitations associated with subcutaneous administration and to provide an improved time–action insulin profile more closely simulating physiological prandial insulin release. Among these, pulmonary insulin delivery has shown the most promise. Technosphere® Inhaled Insulin (TI) is a rapid-acting inhaled human insulin recently approved by the FDA for prandial insulin therapy. In this article we discuss the pharmacokinetic and pharmacodynamic properties of TI, and, based on key studies performed during its clinical development, the implications for improved postprandial glucose control.
机译:近几十年来,胰岛素治疗选择的进步显着改善了糖尿病的管理。尽管如此,在许多糖尿病患者中,血糖控制仍然不理想。尽管随着皮下注射速效胰岛素类似物的发展,餐后血糖控制得到了改善,但目前可用的胰岛素尚不能完全模仿进餐后内源性分泌胰岛素的生理时间作用谱。代谢作用的延迟发作和作用的延长会引起餐后高血糖和餐后低血糖的风险。为了克服与皮下给药相关的局限性,并提供一种改善的时效胰岛素谱,更紧密地模拟了生理性膳食胰岛素的释放,已对胰岛素的多种替代途径进行了研究。在这些中,肺部胰岛素的输送显示出最大的希望。 Technosphere®吸入式胰岛素(TI)是最近被FDA批准用于餐后胰岛素治疗的速效吸入人胰岛素。在本文中,我们讨论了TI的药代动力学和药效动力学特性,并基于在其临床开发过程中进行的关键研究,对改善餐后血糖控制的意义。

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