利拉鲁肽与西他列汀对2型糖尿病患者血糖控制和体重的临床疗效：瑞典的一项回顾性评估
Clinical Effectiveness of Liraglutide vs Sitagliptin on Glycemic Control and Body Weight in Patients with Type 2 Diabetes: A Retrospective Assessment in Sweden.
作者信息
Lind Marcus, Matsson Per-Olov, Linder Ragnar, Svenningsson Irene, Jørgensen Leif, Ploug Uffe J, Gydesen Helge, Dorkhan Mozhgan, Larsen Sara, Johansson Gunnar
机构信息
Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.
Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.
出版信息
Diabetes Ther. 2016 Jun;7(2):321-33. doi: 10.1007/s13300-016-0173-z. Epub 2016 May 23.
INTRODUCTION
The aim of the present study was to use real-world data from Swedish primary-care and national registries to understand clinical outcomes in patients with Type 2 diabetes (T2D) treated with liraglutide in clinical practice, and to compare with data from those treated with sitagliptin.
METHODS
This was a non-interventional, retrospective study conducted between February 2014 and September 2014 using T2D patient data from Swedish primary-care centers and national healthcare registries. The primary objective was to assess the effectiveness of liraglutide in control of glycemia and body weight in clinical practice (stage 1). The secondary objective was to compare the clinical effectiveness of liraglutide with sitagliptin on glycemic control and body weight in clinical practice in a propensity-score-matched population (stage 2).
RESULTS
In stage 1 (n = 402), 39.4% of patients treated with liraglutide achieved ≥1.0% (10.9 mmol/mol) reduction in glycated hemoglobin (HbA1c) after 180 days of treatment and 54.9% achieved the target HbA1c of <7.0% (53.0 mmol/mol). Moreover, compared with baseline, 22.5% of patients treated with liraglutide achieved both ≥1.0% reduction in HbA1c and ≥3.0% reduction in body weight. In stage 2, a significantly greater proportion of patients receiving liraglutide (n = 180) than sitagliptin (n = 208) achieved ≥1.0% reduction in HbA1c [52.9% vs 33.5%, respectively (P = 0.0002)]. Mean body-weight loss was also significantly greater in patients receiving liraglutide vs sitagliptin [-3.5 vs -1.3 kg, respectively (P < 0.0001)].
CONCLUSION
This study provides real-world evidence from Sweden corroborating previous clinical trials that demonstrate greater efficacy of liraglutide over sitagliptin on glycemic control and body-weight reduction in patients with T2D.
FUNDING
Novo Nordisk A/S.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT02077946.
引言
本研究的目的是利用来自瑞典初级保健机构和国家登记处的真实世界数据，了解在临床实践中接受利拉鲁肽治疗的2型糖尿病（T2D）患者的临床结局，并与接受西他列汀治疗的患者的数据进行比较。
方法
这是一项非干预性回顾性研究，于2014年2月至2014年9月期间进行，使用了来自瑞典初级保健中心和国家医疗保健登记处的T2D患者数据。主要目标是评估利拉鲁肽在临床实践中（第1阶段）控制血糖和体重的有效性。次要目标是在倾向评分匹配的人群中（第2阶段）比较利拉鲁肽与西他列汀在临床实践中对血糖控制和体重的临床有效性。
结果
在第1阶段（n = 402），接受利拉鲁肽治疗的患者中，39.4%在治疗180天后糖化血红蛋白（HbA1c）降低≥1.0%（10.9 mmol/mol），54.9%达到了HbA1c<7.0%（53.0 mmol/mol）的目标。此外，与基线相比，接受利拉鲁肽治疗的患者中有22.5%的HbA1c降低≥1.0%且体重降低≥3.0%。在第2阶段，接受利拉鲁肽治疗的患者（n = 180）中HbA1c降低≥1.0%的比例显著高于接受西他列汀治疗的患者（n = 208）[分别为52.9%和33.5%（P = 0.0002）]。接受利拉鲁肽治疗的患者的平均体重减轻也显著大于接受西他列汀治疗的患者[-3.5 kg对-1.3 kg，分别（P < 0.0001）]。
结论
本研究提供了来自瑞典的真实世界证据，证实了先前的临床试验，即利拉鲁肽在T2D患者的血糖控制和体重减轻方面比西他列汀更有效。
资助
诺和诺德公司。
试验注册
ClinicalTrials.gov标识符NCT02077946。
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