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一项关于南欧地区开始使用达格列净的2型糖尿病患者临床特征的多国真实世界研究。

A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe.

作者信息

Fadini Gian Paolo, Tentolouris Nikolaos, Caballero Mateos Irene, Bellido Castañeda Virginia, Morales Portillo Cristóbal

机构信息

For the DARWIN-T2D Network of the Italian Diabetes Society, Department of Medicine, University of Padova, 35128, Padua, Italy.

1st Department of Propaedeutic Internal Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Diabetes Ther. 2020 Feb;11(2):423-436. doi: 10.1007/s13300-019-00744-6. Epub 2019 Dec 20.

Abstract

INTRODUCTION

A real-world study was performed to describe the clinical characteristics of patients who received dapagliflozin to better understand differences when initiating dapagliflozin in various countries and different prescribing settings.

METHODS

We assessed pooled data from observational studies carried out in Italy (n = 2484), Spain (n = 564) and Greece (n = 87). The primary objective was to compare the clinical profile of patients initiating dapagliflozin in the three countries. We also evaluated the percentage of patients who received dapagliflozin in clinical practice who satisfied DECLARE-TIMI 58 enrolment criteria.

RESULTS

In Italy and Spain, around 90% of patients were receiving metformin vs. 66% in Greece (p < 0.0001). Patients in Greece had lower levels of estimated glomerular filtration rate and lower prevalence rates of retinopathy, prior stroke, acute myocardial infarction, peripheral arterial disease and atherosclerotic cardiovascular disease. Grouping the cohorts by prescribing setting (primary vs. specialist care), baseline HbA was lower in primary care (8.4 ± 1.7 vs. 8.7 ± 1.5, respectively; p < 0.0001). Significantly more patients were receiving other medications for concomitant conditions in specialist care. A total of 1416 patients (48%) did not meet DECLARE inclusion criteria, while 1561 (52%) patients met the criteria (Greece 41.05%, Italy 53.19%, Spain 51.35%).

CONCLUSIONS

Significant differences were seen among patients initiating dapagliflozin in southern Europe. Our results suggest that dapagliflozin was being initiated at different stages of the disease according to the country and prescribing settings. Such geographic heterogeneity may have an impact upon effectiveness of dapagliflozin on glucose lowering, as well as cardiovascular and renal outcomes.

摘要

引言

开展了一项真实世界研究,以描述接受达格列净治疗的患者的临床特征,从而更好地了解在不同国家和不同处方环境下起始使用达格列净时的差异。

方法

我们评估了在意大利(n = 2484)、西班牙(n = 564)和希腊(n = 87)开展的观察性研究的汇总数据。主要目标是比较这三个国家起始使用达格列净的患者的临床特征。我们还评估了在临床实践中接受达格列净治疗且符合DECLARE-TIMI 58纳入标准的患者百分比。

结果

在意大利和西班牙,约90%的患者正在接受二甲双胍治疗,而在希腊这一比例为66%(p < 0.0001)。希腊患者的估计肾小球滤过率较低,视网膜病变、既往中风、急性心肌梗死、外周动脉疾病和动脉粥样硬化性心血管疾病的患病率也较低。按处方环境(初级保健与专科护理)对队列进行分组后,初级保健中的基线糖化血红蛋白水平较低(分别为8.4±1.7和8.7±1.5;p < 0.0001)。在专科护理中,接受其他药物治疗合并症的患者明显更多。共有1416名患者(48%)不符合DECLARE纳入标准,而1561名(52%)患者符合标准(希腊41.05%,意大利53.19%,西班牙51.35%)。

结论

在南欧起始使用达格列净的患者之间存在显著差异。我们的结果表明,根据国家和处方环境,达格列净在疾病的不同阶段起始使用。这种地理异质性可能会影响达格列净的降糖效果以及心血管和肾脏结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af4a/6995805/5c5baf349336/13300_2019_744_Fig1_HTML.jpg

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