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利司那肽、艾塞那肽和利拉鲁肽笔式装置的比较评估:一项基于用户的初步研究。

Comparative Assessment of Lixisenatide, Exenatide, and Liraglutide Pen Devices: A Pilot User-Based Study.

作者信息

Stauder Udo, Enginee Diplom, Elton Hina, Penfornis Alfred, Edelman Steve

机构信息

Sanofi-Aventis, Frankfurt, Germany DCA Design International, Warwick, UK Jean Minjoz Hospital, Besançon, France University of California, San Diego, San Diego, CA, USA

Sanofi-Aventis, Frankfurt, Germany.

出版信息

J Diabetes Sci Technol. 2014 Jan;8(1):123-131. doi: 10.1177/1932296813511733. Epub 2014 Jan 1.

Abstract

BACKGROUND

Glucagon-like peptide-1 (GLP-1) receptor agonists are a relatively recent addition to the treatment options for type 2 diabetes mellitus (T2DM) and are administered using prefilled pen devices.

METHOD

In this open-label task and interview-based pilot study, 3 GLP-1 receptor agonist pen devices-exenatide (Byetta, Bristol-Myers Squibb/AstraZeneca), liraglutide (Victoza, Novo Nordisk), and lixisenatide (Lyxumia, Sanofi-Aventis)-were comparatively assessed in a randomized order in 30 participants with T2DM for ease of use, using a series of key performance measures (time taken to complete a series of tasks, number of user errors [successful performance], and user satisfaction rating). Linear and logistic regression analysis was conducted for the lixisenatide and liraglutide pens versus the exenatide pen. Participants' mean age was 60 years; 27% and 20% of the participants had visual impairments and reduced manual dexterity, respectively.

RESULTS

Tasks were completed faster (P < .001) and with higher successful performance (P = .001) with the lixisenatide pen than with the exenatide pen, whereas the liraglutide pen was not statistically significant versus the exenatide pen on these parameters. Overall, user satisfaction was statistically higher for the lixisenatide and liraglutide pens versus the exenatide pen (P < .001 for both).

CONCLUSIONS

Lixisenatide and liraglutide pens are associated with higher user satisfaction compared with the exenatide pen. In addition, the lixisenatide pen is faster and results in fewer errors than its comparator (exenatide). The lixisenatide pen may therefore be a suitable choice for patients with T2DM, including older and pen device-naïve patients, and those with visual impairments and reduced manual dexterity.

摘要

背景

胰高血糖素样肽-1(GLP-1)受体激动剂是2型糖尿病(T2DM)治疗选择中相对较新的药物,通过预填充笔式装置给药。

方法

在这项基于开放标签任务和访谈的试点研究中,对3种GLP-1受体激动剂笔式装置——艾塞那肽(百泌达,百时美施贵宝/阿斯利康)、利拉鲁肽(维达列汀,诺和诺德)和利司那肽(利时敏,赛诺菲-安万特)——在30名T2DM患者中按随机顺序进行比较评估,以一系列关键性能指标(完成一系列任务所需时间、用户错误数量[成功操作]和用户满意度评分)来评估易用性。对利司那肽笔和利拉鲁肽笔与艾塞那肽笔进行线性和逻辑回归分析。参与者的平均年龄为60岁;分别有27%和20%的参与者有视力障碍和手部灵活性下降。

结果

使用利司那肽笔完成任务的速度比使用艾塞那肽笔更快(P <.001),且成功操作率更高(P =.001),而在这些参数上,利拉鲁肽笔与艾塞那肽笔相比无统计学意义。总体而言,利司那肽笔和利拉鲁肽笔的用户满意度在统计学上高于艾塞那肽笔(两者均为P <.001)。

结论

与艾塞那肽笔相比,利司那肽笔和利拉鲁肽笔的用户满意度更高。此外,利司那肽笔比其对照药物(艾塞那肽)更快,且错误更少。因此,利司那肽笔可能是T2DM患者的合适选择,包括老年患者和初次使用笔式装置的患者,以及有视力障碍和手部灵活性下降的患者。

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