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达格列净对比安慰剂对伴或不伴心力衰竭的糖尿病患者左心室重构的影响:REFORM 试验。

Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial.

机构信息

Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.

Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.

出版信息

Diabetes Care. 2020 Jun;43(6):1356-1359. doi: 10.2337/dc19-2187. Epub 2020 Apr 3.

DOI:10.2337/dc19-2187
PMID:32245746
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7245350/
Abstract

OBJECTIVE

To determine the effects of dapagliflozin in patients with heart failure (HF) and type 2 diabetes mellitus (T2DM) on left ventricular (LV) remodeling using cardiac MRI.

RESEARCH DESIGN AND METHODS

We randomized 56 patients with T2DM and HF with LV systolic dysfunction to dapagliflozin 10 mg daily or placebo for 1 year, on top of usual therapy. The primary end point was difference in LV end-systolic volume (LVESV) using cardiac MRI. Key secondary end points included other measures of LV remodeling and clinical and biochemical parameters.

RESULTS

In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling. However, it reduced diastolic blood pressure and loop diuretic requirements while increasing hemoglobin, hematocrit, and ketone bodies. There was a trend toward lower weight.

CONCLUSIONS

We were unable to determine with certainty whether dapagliflozin in patients with T2DM and HF had any effect on LV remodeling. Whether the benefits of dapagliflozin in HF are due to remodeling or other mechanisms remains unknown.

摘要

目的

使用心脏 MRI 评估达格列净对心力衰竭(HF)合并 2 型糖尿病(T2DM)患者左心室(LV)重构的影响。

研究设计和方法

我们将 56 例 LV 收缩功能障碍的 T2DM 合并 HF 患者随机分为达格列净 10mg/d 组或安慰剂组,均在常规治疗基础上加用药物,疗程 1 年。主要终点为心脏 MRI 检测的 LV 收缩末期容积(LVESV)差异。次要终点包括其他 LV 重构指标和临床生化参数。

结果

在本研究队列中,达格列净对 LVESV 或任何其他 LV 重构参数均无影响。但可降低舒张压和袢利尿剂需求,同时增加血红蛋白、红细胞压积和酮体。体重有降低趋势。

结论

我们尚不能确定达格列净对 T2DM 合并 HF 患者的 LV 重构是否有确切疗效。HF 中达格列净的获益是否源于重构改善或其他机制仍不清楚。

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Circulation. 2020 Feb 25;141(8):704-707. doi: 10.1161/CIRCULATIONAHA.119.044235. Epub 2019 Nov 11.
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J Am Heart Assoc. 2019 Oct 15;8(20):e013389. doi: 10.1161/JAHA.119.013389. Epub 2019 Oct 12.
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N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
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SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials.SGLT2 抑制剂用于 2 型糖尿病的心血管和肾脏结局的一级和二级预防:心血管结局试验的系统评价和荟萃分析。
Lancet. 2019 Jan 5;393(10166):31-39. doi: 10.1016/S0140-6736(18)32590-X. Epub 2018 Nov 10.
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