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与对照药物相比,口服司美格鲁肽使糖化血红蛋白(HbA)联合降幅≥1.0%且体重减轻≥5.0%或≥10.0%的效果更显著。

Greater Combined Reductions of HbA ≥ 1.0% and Body Weight Loss ≥ 5.0% or ≥ 10.0% with Orally Administered Semaglutide Versus Comparators.

作者信息

Dungan Kathleen M, Bardtrum Lars, Christiansen Erik, Eliasson Johanna, Mellbin Linda, Woo Vincent C, Vilsbøll Tina

机构信息

Division of Endocrinology, Diabetes and Metabolism, The Ohio State University, 1581 Dodd Drive, Columbus, OH 43210, USA.

Novo Nordisk A/S, Søborg, Denmark.

出版信息

Diabetes Ther. 2023 Aug;14(8):1415-1425. doi: 10.1007/s13300-023-01413-5. Epub 2023 May 31.

Abstract

INTRODUCTION

A post hoc analysis of the PIONEER 1-5 and 8 trials assessed the clinically relevant composite endpoints of HbA (glycated haemoglobin) reduction ≥ 1% and body weight loss of ≥ 5% or ≥ 10% with orally administered semaglutide versus comparators.

METHODS

In the PIONEER trials, people with type 2 diabetes were randomised to orally administered semaglutide versus placebo (PIONEER 1, 4, 5 and 8), empagliflozin (PIONEER 2), sitagliptin (PIONEER 3) and liraglutide (PIONEER 4) for 26-78 weeks. This analysis assessed the proportion of people achieving an HbA reduction of ≥ 1% and body weight loss of ≥ 5% at week 26 and at end of treatment, and the proportion of people achieving an HbA reduction of ≥ 1% and body weight loss of ≥ 10% at end of treatment.

RESULTS

Overall, 3506 people in PIONEER 1-5 and 8 were included. At week 26 and at end of treatment, odds of achieving the composite endpoint of an HbA reduction of ≥ 1% and body weight loss of ≥ 5% were significantly greater with orally administered semaglutide 14 mg than with placebo (PIONEER 1, 4, 5 and 8; all p < 0.0001), empagliflozin 25 mg (PIONEER 2, p < 0.0001), sitagliptin 100 mg (PIONEER 3, p < 0.0001) and liraglutide 1.8 mg (PIONEER 4, p < 0.0001). Odds of achieving the composite endpoint of HbA reduction of ≥ 1% and body weight loss of ≥ 10% at end of treatment were also significantly greater with orally administered semaglutide versus comparators.

CONCLUSION

In PIONEER 1-5 and 8, odds of achieving clinically relevant reductions in both HbA and body weight were significantly greater with orally administered semaglutide versus comparators.

摘要

引言

对先锋1-5和8试验进行的事后分析评估了口服司美格鲁肽与对照药物相比,糖化血红蛋白(HbA)降低≥1%且体重减轻≥5%或≥10%这两个具有临床意义的复合终点。

方法

在先锋试验中,2型糖尿病患者被随机分为口服司美格鲁肽组与安慰剂组(先锋1、4、5和8试验)、恩格列净组(先锋2试验)、西格列汀组(先锋3试验)和利拉鲁肽组(先锋4试验),治疗26-78周。该分析评估了在第26周和治疗结束时实现HbA降低≥1%且体重减轻≥5%的患者比例,以及在治疗结束时实现HbA降低≥1%且体重减轻≥10%的患者比例。

结果

总体而言,先锋1-5和8试验共纳入3506例患者。在第26周和治疗结束时,口服14mg司美格鲁肽实现HbA降低≥1%且体重减轻≥5%这一复合终点的几率显著高于安慰剂(先锋1、4、5和8试验;所有p<0.0001)、25mg恩格列净(先锋2试验,p<0.0001)、100mg西格列汀(先锋3试验,p<0.0001)和1.8mg利拉鲁肽(先锋4试验,p<0.0001)。与对照药物相比,口服司美格鲁肽在治疗结束时实现HbA降低≥1%且体重减轻≥10%这一复合终点的几率也显著更高。

结论

在先锋1-5和8试验中,口服司美格鲁肽实现HbA和体重临床相关降低的几率显著高于对照药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bb1/10299987/d4fef12f9af7/13300_2023_1413_Fig1_HTML.jpg

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