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Drugs. 2015 Sep;75(14):1679-86. doi: 10.1007/s40265-015-0472-0.
Afrezza® (insulin human) inhalation powder is a rapid-acting Technosphere® insulin (TI) administered via a breath-powered oral inhaler to patients with diabetes requiring prandial insulin. TI, a dry powdered formulation of recombinant human insulin adsorbed onto a proprietary carrier, is designed to deliver insulin to the deep lung, at the level of the alveoli, where it is absorbed into the systemic circulation. In a randomized, open-label, multinational, phase III trial (trial 171) in type 1 diabetes (T1DM) patients, prandial TI via the Gen2 inhaler provided noninferior glycated haemoglobin (HbA1c) lowering compared with prandial subcutaneous insulin aspart. Although TI was associated with less HbA1c lowering, it provided significantly lower fasting plasma glucose levels and significantly less hypoglycaemia and bodyweight gain compared with insulin aspart. In a randomized, double-blind, placebo-controlled, multinational, phase III trial (trial 175) in type 2 diabetes (T2DM) patients, prandial TI via the Gen2 inhaler provided superior HbA1c lowering compared with inhaled placebo. Cough was the most commonly occurring non-hypoglycaemia adverse event across both studies. In a pooled analysis of tolerability data from phase II and III studies, the most commonly occurring non-hypoglycaemia adverse events in T1DM and T2DM patients were cough and throat pain/irritation. However, cough was generally mild, dry and decreased over time. In addition, treatment with TI was associated with positive patient-reported outcomes. Insulin human inhalation powder is an effective and generally well-tolerated agent for the prandial treatment of hyperglycaemia in T1DM and T2DM patients and may provide a solution to insulin initiation barriers such as injection phobia, concerns of bodyweight gain and concerns of hypoglycaemia.
阿夫扎来（胰岛素人）吸入粉是一种快速作用的 Technosphere® 胰岛素（TI），通过呼吸动力口腔吸入器给药，用于需要餐前胰岛素的糖尿病患者。TI 是重组人胰岛素的干粉制剂，吸附在专有载体上，旨在将胰岛素输送到肺部深处，在肺泡水平，被吸收到全身循环中。在一项随机、开放标签、多中心、III 期试验（试验 171）中，1 型糖尿病（T1DM）患者使用 Gen2 吸入器进行餐前 TI 治疗，与餐前门冬胰岛素相比，糖化血红蛋白（HbA1c）降低不劣效。尽管 TI 与 HbA1c 降低幅度较小，但与门冬胰岛素相比，它能显著降低空腹血糖水平，并显著减少低血糖和体重增加。在一项随机、双盲、安慰剂对照、多中心、III 期试验（试验 175）中，2 型糖尿病（T2DM）患者使用 Gen2 吸入器进行餐前 TI 治疗，与吸入安慰剂相比，HbA1c 降低更优。在这两项研究中，咳嗽是最常见的非低血糖不良事件。在 II 期和 III 期研究的耐受性数据汇总分析中，T1DM 和 T2DM 患者最常见的非低血糖不良事件是咳嗽和咽喉疼痛/刺激。然而，咳嗽通常是轻微的、干性的，并随着时间的推移而减少。此外，TI 治疗与积极的患者报告结果相关。胰岛素人吸入粉是一种有效且通常耐受良好的药物，可用于治疗 1 型和 2 型糖尿病患者的餐后高血糖症，并且可能为胰岛素起始障碍提供解决方案，如注射恐惧症、体重增加的担忧和低血糖的担忧。
