A randomized, open-label, comparative, crossover trial on preference, efficacy, and safety profiles of lispro insulin u-100 versus concentrated lispro insulin u-200 in patients with type 2 diabetes mellitus: a possible contribution to greater treatment adherence
A randomized, open-label, comparative, crossover trial on preference, efficacy, and safety profiles of lispro insulin u-100 versus concentrated lispro insulin u-200 in patients with type 2 diabetes mellitus: a possible contribution to greater treatment adherence
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DOI：
10.1080/14740338.2018.1453495
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发表时间：
2018-01-01
影响因子：
3.1
通讯作者：
Strollo, Felice
中科院分区：
文献类型：
--
作者：
Gentile, Sandro;Fusco, Alessandra;Strollo, Felice
背景：在过去的几年中，一些杰出的药理学进展使创新药物复杂装置成为可能。然而，令人失望的是，仍有太多患者未能达到当前指南建议的代谢目标。不正确的胰岛素给药技术可能会严重影响T2DM患者的代谢控制。本研究的目的是比较T2DM患者使用浓缩胰岛素类似物制剂（U-200 lispro）与使用标准U-100 lispro观察到的血糖控制情况。我们研究的次要终点是患者对U-200 lispro的偏好和性能评分。方法：纳入126例T2DM患者。他们也被评估为受限关节活动综合征（LJMS），定义为至少两个主要上肢解剖区域受限。经过为期4周的胰岛素注射教育。其中一半被随机分配到U-100 lispro，一半被随机分配到U-200, 12周后他们被切换到另一种制剂12周。最后还进行了问卷调查，以调查患者的偏好。结果：U-100利斯普罗治疗组空腹血糖、糖化血红蛋白、重度或轻度低血糖率及每日速效胰岛素模拟物剂量均无显著变化，而U-200利斯普罗治疗组上述参数均有显著改善，胰岛素需用量降低约20%。此外，患者对问卷的回答指出，由于完成注射的困难较少，U-200 lispro更倾向于继续治疗。讨论：U-200装置代谢效果较好的解释可能是内活塞惯性和体积较小，完全注射时间较短。结论：胰岛素处方前检查LJIMS可作为一种标准做法，旨在根据患者的具体特点和能力选择最合适的装置。使用u - 200lispro可以改善治疗依从性和代谢控制。这也将导致成本降低，每年节省大约一半的笔的数量和时间花在填写处方和离开药房。
Background: Several outstanding pharmacological advances making innovative drugs sophisticateddevices available during the last few years. Nevertheless too many patients still disappointingly fail to meetthe metabolic targets suggested by current guidelines. Incorrect insulin administration techniques may greatly affect metabolic control in T2DM people. The aim of our study was to compare glycemic control associated with a concentrated insulin analog preparation (U-200 lispro) in people with T2DM to the one observed with standard U-100 lispro. The secondary endpoint of our study was patients' preference and performance ratings of U-200 lispro.Methods: 126 patients with T2DM were enrolled. They were also assessed for limited joint mobility syndrome (LJMS),defined as limitation in at least two anatomical areas of the dominant upper extremity. After a 4-weekstructured insulin injection education period. Half of them were randomized to U-100 lispro, half to U-200 and after 12weeks they were switched to the other preparation for 12weeks. At the end a questionnaire was also administered to investigate patient preference.Results: No significant variation in fasting blood glucose, HbA1c, severe or mild hypoglycemic rate and daily fast-acting insulin analog dose was observed with U-100 lispro while U-200 lispro treatment was associated with a significant improvement of all the above mentioned parameters and with around 20% decrease in insulin requirement. Moreover patients' answers to the questionnaire pointed out a higher preference for U-200 lispro for continuing treatment due to fewer difficulties completing injection.Discussion: The explanation of better metabolic results with the U-200 device might be the lower inner piston inertia and volume and shorter duration of a complete injection.Conclusions: Checking for LJIMS before insulin prescription could be adopted as a standard practiceaimed at choosing the most suitable device for patient's specific characteristics and abilities. The use of U-200 lispro might improve treatment adherence and metabolic control. This would also result intocost reduction by saving about half the amount of pens per year and of time spent to both fill prescriptionand dump the pharmacy.