Chan Jason, Cheng-Lai Angela
From the Department of Pharmacy, Montefiore Medical Center, Bronx, NY.
Cardiol Rev. 2017 May/Jun;25(3):140-146. doi: 10.1097/CRD.0000000000000143.
Insulin is the most effective blood glucose lowering agent and remains one of the cornerstones of diabetes management. However, many individuals with diabetes are either reluctant to initiate or are nonadherent to their insulin therapy for various reasons, including fear of frequent injections. Technosphere Insulin (TI) is a novel inhaled insulin powder that is approved by the United States Food and Drug Administration for the management of diabetes. The results from 2 phase III clinical trials have shown that TI was noninferior to subcutaneous insulin aspart and superior to inhaled placebo in lowering HbA1c in patients with diabetes mellitus types 1 and 2, respectively. Across both studies, TI appears to be generally well tolerated, with the most common adverse events being hypoglycemia and cough. However, long-term pulmonary safety concerns have not been addressed and additional studies are needed. Overall, TI appears to be a promising noninvasive prandial insulin alternative for individuals with diabetes who are at risk for medication nonadherence due to aversion to frequent injections. This article provides a review of the historical development of TI, its safety and efficacy data, and its advantages and disadvantages over traditional injectable insulins.
胰岛素是最有效的降血糖药物，仍是糖尿病管理的基石之一。然而，许多糖尿病患者由于各种原因，包括害怕频繁注射，要么不愿开始胰岛素治疗，要么不坚持胰岛素治疗。技术球胰岛素（TI）是一种新型吸入式胰岛素粉末，已获美国食品药品监督管理局批准用于糖尿病管理。两项III期临床试验结果表明，TI在降低1型和2型糖尿病患者的糖化血红蛋白（HbA1c）方面，不劣于皮下注射门冬胰岛素，且优于吸入式安慰剂。在两项研究中，TI总体耐受性良好，最常见的不良事件是低血糖和咳嗽。然而，长期肺部安全性问题尚未得到解决，还需要更多研究。总体而言，对于因厌恶频繁注射而有药物治疗依从性风险的糖尿病患者，TI似乎是一种有前景的非侵入性餐时胰岛素替代品。本文综述了TI的历史发展、其安全性和有效性数据，以及与传统注射用胰岛素相比的优缺点。
