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卡格列净治疗2型糖尿病患者的糖化血红蛋白、血压及体重减轻的真实世界评估:来自佛罗里达州医院网络的电子病历分析

Real-world evaluation of Hba1c, blood pressure, and weight loss among patients with type 2 diabetes mellitus treated with canagliflozin: an analysis of electronic medical records from a network of hospitals in Florida.

作者信息

Tanton Damon, Duh Mei Sheng, Lafeuille Marie-Hélène, Lefebvre Patrick, Pilon Dominic, Zhdanava Maryia, Emond Bruno, Inman Doreen, Bailey Robert A

机构信息

a Florida Hospital Research Institute , Orlando , FL , USA.

b Analysis Group Inc. , Boston , MA , USA.

出版信息

Curr Med Res Opin. 2018 Jun;34(6):1099-1115. doi: 10.1080/03007995.2018.1444591. Epub 2018 Mar 5.

Abstract

OBJECTIVE

Clinical trials and real-world studies reported that canagliflozin (CANA) improved HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM). This study examines if previous results hold regionally and within specific patient sub-groups.

METHODS

Adults with T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in electronic medical records (January 1, 2012-February 15, 2017) from a network of hospitals in Florida. Quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected thresholds were HbA1c < 7%, BP < 140/90 mmHg, and weight loss ≥5%. Sub-groups included patients ≥65 years old, with African American race, with CANA dose increase, initiating CANA in an endocrinology setting, and initiating CANA in a primary care setting.

RESULTS

Overall, 1,259 patients (mean age = 56.7 years; 51.2% female, 70.4% White) were identified. Among patients with a baseline HbA1c ≥ 7%, 16.1% had an HbA1c < 7% 3 months following CANA initiation, and the mean HbA1c decreased from 8.8% to 8.1%. Among patients with a baseline systolic BP ≥140 mmHg or diastolic BP ≥ 90 mmHg, 59.3% attained a systolic BP < 140 mmHg and 77.3% a diastolic BP < 90 mmHg after 3 months. HbA1c and BP responses were sustained through 12 months. The proportion of patients with a weight loss from baseline ≥5% increased from 17.0% at 3 months to 31.1% at 12 months. Consistent trends were observed for all sub-groups.

CONCLUSIONS

In CANA-treated patients and patient sub-groups from a network of Florida hospitals, improvements in quality measures and response durability were similar to clinical trials and other real-world studies.

摘要

目的

临床试验和真实世界研究报告称,卡格列净(CANA)可改善2型糖尿病(T2DM)患者的糖化血红蛋白(HbA1c)、血压(BP)和体重。本研究旨在检验先前的结果在地区范围内以及特定患者亚组中是否成立。

方法

从佛罗里达州医院网络的电子病历中(2012年1月1日至2017年2月15日)识别出首次开具CANA处方(索引)前有≥12个月临床活动的T2DM成年患者。在基线以及索引后3、6、9和12个月描述质量指标。选定的阈值为HbA1c<7%、血压<140/90 mmHg以及体重减轻≥5%。亚组包括年龄≥65岁、非裔美国人、CANA剂量增加、在内分泌科开始使用CANA以及在初级保健机构开始使用CANA的患者。

结果

共识别出1259例患者(平均年龄 = 56.7岁;51.2%为女性,70.4%为白人)。在基线HbA1c≥7%的患者中,16.1%在开始使用CANA后3个月时HbA1c<7%,且平均HbA1c从8.8%降至8.1%。在基线收缩压≥140 mmHg或舒张压≥90 mmHg的患者中,3个月后59.3%的患者收缩压<140 mmHg,77.3%的患者舒张压<90 mmHg。HbA1c和血压反应持续至12个月。体重较基线减轻≥5%的患者比例从3个月时的17.0%增至12个月时的31.1%。所有亚组均观察到一致趋势。

结论

在佛罗里达州医院网络接受CANA治疗的患者及其亚组中,质量指标的改善和反应持久性与临床试验及其他真实世界研究相似。

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