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回顾性数据库分析:评估在基层医疗环境中,2型糖尿病(T2DM)患者从其他二肽基肽酶-4(DPP-4)抑制剂治疗转换为阿格列汀治疗的临床结局。

Retrospective Database Analysis Evaluating the Clinical Outcomes of Changing Treatment of People with Type 2 Diabetes Mellitus (T2DM) from Other DPP-4 Inhibitor Therapy to Alogliptin in a Primary Care Setting.

作者信息

Strain W David, McEwan Phil, Howitt Heena, Meadowcroft Simon

机构信息

Diabetes and Vascular Medicine Research, University of Exeter Medical School, Exeter, UK.

Health Economics and Outcomes Research Ltd, Cardiff Gate Business Park, Cardiff, UK.

出版信息

Diabetes Ther. 2019 Aug;10(4):1499-1507. doi: 10.1007/s13300-019-0662-y. Epub 2019 Jul 1.

DOI:10.1007/s13300-019-0662-y
PMID:31264097
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6612350/
Abstract

INTRODUCTION

Although some differences between individual dipeptidyl peptidase-4 (DPP-4) inhibitors may exist, the National Institute for Health and Clinical Excellence (NICE) have recommended that 'prescribers should be encouraged to select the individual DPP-4 inhibitor with the lowest acquisition cost available to them, where all other factors are equal'. We aimed to determine whether or not 'within class' switching to alogliptin, the DPP-4 inhibitor with lowest acquisition cost, is a clinically appropriate strategy.

METHODS

This study evaluated people with type 2 diabetes taking DPP-4 inhibitor therapy in addition to at least one other diabetes therapy. Primary care records were reviewed from six clinical commissioning groups (CCGs). For people who had been switched from other DPP-4 inhibitors to alogliptin, an assessment of the impact of switch on both absolute haemoglobin A1c (HbA1c) levels and on HbA1c trajectory was undertaken. Persistence on alogliptin and the need for therapy intensification was also assessed.

RESULTS

Overall, 865 people with diabetes met the eligibility criteria for the study. There was no significant difference between pre- and post-switch mean HbA1c level [8.44% (SD 1.52%) vs 8.42% (1.62%), p = 0.6]. Similarly, for patients where there was sufficient data to assess the impact of switching on HbA1c trajectory (n = 319) minimal impact was identified (actual HbA1c at 3 months 8.33% vs projected 8.31%). The majority of people with diabetes (80.76%) remained on alogliptin treatment at 6 months and only 4.54% required additional diabetes therapies. Switching to alogliptin resulted in a median saving of £7.24 per patient-month.

CONCLUSION

Switching United Kingdom (UK) primary care patients from other DPP-4 inhibitors to alogliptin did not result in a statistically significant or clinically meaningful change in HbA1c level and few required the addition of further diabetes therapies, suggesting that therapy change or intensification was not considered necessary in most patients who were switched to alogliptin.

TRIAL REGISTRATION

ENCePP clinical trial registration number EUPAS29153.

FUNDING

Takeda UK Ltd.

摘要

引言

尽管各个二肽基肽酶 -4(DPP -4)抑制剂之间可能存在一些差异,但英国国家卫生与临床优化研究所(NICE)建议“在所有其他因素相同的情况下,应鼓励开处方者选择采购成本最低的个体DPP -4抑制剂”。我们旨在确定“在同类药物中”换用阿格列汀(采购成本最低的DPP -4抑制剂)是否为一种临床适宜策略。

方法

本研究评估了正在接受DPP -4抑制剂治疗且至少还接受一种其他糖尿病治疗的2型糖尿病患者。查阅了六个临床委托小组(CCG)的初级医疗记录。对于已从其他DPP -4抑制剂换用阿格列汀的患者,评估了换药对糖化血红蛋白(HbA1c)绝对水平以及HbA1c变化轨迹的影响。还评估了患者对阿格列汀的持续用药情况以及强化治疗的需求。

结果

总体而言,865名糖尿病患者符合该研究的纳入标准。换药前后的平均HbA1c水平无显著差异[8.44%(标准差1.52%)对8.42%(1.62%),p = 0.6]。同样,对于有足够数据评估换药对HbA1c变化轨迹影响的患者(n = 319),发现影响极小(3个月时实际HbA1c为8.33%,而预测值为8.31%)。大多数糖尿病患者(80.76%)在6个月时仍继续使用阿格列汀治疗,只有4.54%的患者需要额外的糖尿病治疗。换用阿格列汀使每位患者每月节省的费用中位数为7.24英镑。

结论

将英国初级医疗患者从其他DPP -4抑制剂换用阿格列汀后,HbA1c水平在统计学上无显著变化,临床上也无有意义的改变,且很少有患者需要增加进一步的糖尿病治疗,这表明对于大多数换用阿格列汀的患者而言,无需改变治疗方案或强化治疗。

试验注册

ENCEPP临床试验注册号EUPAS29153。

资助

武田英国有限公司。

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