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在基层医疗和专科医疗环境中接受治疗的2型糖尿病患者中利拉鲁肽治疗的有效性和持久性:来自EVIDENCE研究的亚组分析,一项前瞻性、2年随访、观察性、上市后研究。

Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study.

作者信息

Martinez Luc, Penfornis Alfred, Gautier Jean-Francois, Eschwège Eveline, Charpentier Guillaume, Bouzidi Amira, Gourdy Pierre

机构信息

Université Pierre and Marie Curie, Paris, France.

Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.

出版信息

Adv Ther. 2017 Mar;34(3):674-685. doi: 10.1007/s12325-017-0476-0. Epub 2017 Jan 30.

Abstract

INTRODUCTION

The objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings.

METHODS

EVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings.

RESULTS

After 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA (-1.22% and -0.8%, respectively), fasting plasma glucose (FPG) concentration (-39 and -23 mg/dL), body weight (-4.4 and -3.8 kg), and body mass index (BMI) (-1.5 and -1.4 kg/m), all p < 0.0001. Reductions in HbA and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%).

CONCLUSION

Despite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment intensification.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT01226966.

FUNDING

Novo Nordisk A/S.

摘要

引言

本亚组分析的目的是研究利拉鲁肽在初级保健医生(PCP)和专科护理环境中治疗的2型糖尿病(T2D)患者中的有效性。

方法

EVIDENCE是一项对法国3152名近期开始或即将开始使用利拉鲁肽治疗的T2D成人进行的前瞻性观察性研究。我们在PCP和专科护理环境中对患者进行了2年的随访,以评估利拉鲁肽在血糖控制和体重减轻方面的有效性。此外,我们评估了联合降糖治疗的变化、开具利拉鲁肽的原因、患者满意度以及利拉鲁肽在这两种治疗环境中的安全性。

结果

经过2年的随访,1209名PCP治疗患者中有477名(39.0%),1398名专科治疗患者中有297名(21.2%)仍在使用利拉鲁肽并维持糖化血红蛋白(HbA)目标<7.0%。在PCP治疗组和专科治疗组中,平均HbA(分别为-1.22%和-0.8%)、空腹血糖(FPG)浓度(-39和-23mg/dL)、体重(-4.4和-3.8kg)和体重指数(BMI)(-1.5和-1.4kg/m²)均较基线显著降低,所有p<0.0001。与专科治疗患者相比,PCP治疗患者的HbA和FPG降低幅度显著更大,两者p<0.0001。两个队列中的患者治疗满意度也显著提高。与专科治疗患者相比,PCP治疗患者报告的胃肠道不良事件较少(4.5%对16.1%)。

结论

尽管在PCP和专科护理中接受T2D治疗的患者在人口统计学和临床特征方面存在差异,但与专科护理相比,在初级保健中使用利拉鲁肽观察到HbA降低幅度更大,血糖控制耐久性增加。这些数据表明,利拉鲁肽治疗可通过延迟进一步强化治疗的需求使初级保健患者受益。

试验注册

ClinicalTrials.gov标识符,NCT01226966。

资助

诺和诺德公司。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b46/5350193/e552d0fa6767/12325_2017_476_Fig1_HTML.jpg

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