Gautier Jean-Francois, Martinez Luc, Penfornis Alfred, Eschwège Eveline, Charpentier Guillaume, Huret Benoît, Madani Suliya, Gourdy Pierre
Saint-Louis Hospital, Paris, France.
Université Pierre and Marie Curie, Paris, France.
Adv Ther. 2015 Sep;32(9):838-53. doi: 10.1007/s12325-015-0245-x. Epub 2015 Sep 30.
The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice.
This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up.
At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%.
The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials.
Novo Nordisk A/S.
ClinicalTrials.gov identifier, NCT01226966.
本研究旨在调查在随机对照试验中观察到的利拉鲁肽疗效在法国人群的常规临床实践中是否能转化为治疗益处。
这项观察性、前瞻性、多中心研究纳入了3152例2型糖尿病成人患者，这些患者最近开始或即将开始使用利拉鲁肽治疗。在2年的随访期间，对开具利拉鲁肽的原因、利拉鲁肽维持剂量、联合降糖治疗的变化、血糖控制水平、体重和体重指数（BMI）的变化、患者对糖尿病治疗的满意度以及利拉鲁肽的安全性进行了评估。主要研究终点是随访2年后仍接受利拉鲁肽治疗且糖化血红蛋白（HbA1c）<7.0%的患者比例。
在研究结束时，29.5%的患者维持利拉鲁肽治疗并达到HbA1c目标。平均（±标准差）糖化血红蛋白、空腹血糖浓度、体重和BMI较基线水平显著降低[分别从8.46%（±1.46）降至7.44%（±1.20）；从180（±60）降至146（±44）mg/dL；从95.2（±20.0）降至91.1（±19.6）kg；从34.0（±7.2）降至32.5（±6.9）kg/m²，所有P<0.0001]。患者治疗满意度提高，糖尿病治疗满意度问卷状态版平均得分从22.17（±7.64）提高到28.55（±5.79），P<0.0001。主要不良事件类型为胃肠道事件，发生率为10.9%，发生≥1次低血糖事件的患者百分比从6.9%降至4.4%。
EVIDENCE研究结果表明，利拉鲁肽在现实世界临床实践中的有效性与在随机对照试验中观察到的相似。
诺和诺德公司。
ClinicalTrials.gov标识符，NCT01226966。
