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利司那肽的真实临床疗效:24 个月的临床疗效分析。

Real-life experience with Dulaglutide: Analysis of clinical effectiveness to 24 months.

机构信息

Primary Care Center - Cartaya, Huelva, Spain.

Internal Medicine Unit, Hospital Clínico Universitario, Valladolid, Spain; Institute of Biomedical Research of Salamanca (IBSAL), Salamanca, Spain. Universidad Pontificia de Salamanca.

出版信息

Diabetes Res Clin Pract. 2019 Dec;158:107916. doi: 10.1016/j.diabres.2019.107916. Epub 2019 Nov 1.

DOI:10.1016/j.diabres.2019.107916
PMID:31682882
Abstract

OBJECTIVE

Dulaglutide is an agonist of "glucagon-like peptide type 1″ receptors (arGLP1). The clinical efficacy of this molecule is based on reductions in glycosylated hemoglobin (HbA1c) and weight, data shown in the pivotal AWARD studies.

METHODS

We propose a retrospective and multicenter study that allows evaluating the effectiveness of dulaglutide at 24 months after treatment began, under conditions of usual clinical practice, and comparing the results obtained with those that are reflected in the controlled trials.

RESULTS

The results show a reduction in the HbA1c levels -1.4% at 6 M and this reduction were maintained throughout 12 M and 24 M (p < 0.001). Plasma glucose showed significant reductions around -30 mg / dL at 6 months (p < 0.001) that remained until the end of the follow-up at 12 and 24 M, respectively. The weight decreased significantly at 6 M (p < 0.001) but continued decreasing at 12 and 24 M, showing statistically significant differences (p: 0.001).

CONCLUSIONS

Our results are similar to those obtained in pivotal clinical trials and confirm these benefits in real life.

摘要

目的

度拉糖肽是“胰高血糖素样肽-1 型受体”(arGLP1)激动剂。该分子的临床疗效基于糖化血红蛋白(HbA1c)和体重的降低,这一数据在关键性 AWARD 研究中得到证实。

方法

我们提出了一项回顾性、多中心研究,旨在评估在常规临床实践条件下,起始治疗 24 个月后度拉糖肽的疗效,并将结果与对照试验中的结果进行比较。

结果

结果显示,HbA1c 水平在 6 个月时降低了-1.4%,这一降低在 12 个月和 24 个月时一直保持(p<0.001)。血浆葡萄糖在 6 个月时显著降低了约-30mg/dL(p<0.001),并一直持续到 12 个月和 24 个月的随访结束。体重在 6 个月时显著下降(p<0.001),但在 12 个月和 24 个月时仍持续下降,差异具有统计学意义(p:0.001)。

结论

我们的结果与关键性临床试验中的结果相似,证实了这些在真实生活中的获益。

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