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Dapagliflozin Influences Ventricular Hemodynamics and Exercise-Induced Pulmonary Hypertension in Type 2 Diabetes Patients - A Randomized Controlled Trial.
Circulation Journal ( IF 3.3 ) Pub Date : 2020-09-25 , DOI: 10.1253/circj.cj-20-0341
Hiroyuki Kayano 1 , Shinji Koba 1 , Tsutomu Hirano 2 , Taiju Matsui 1 , Hiroto Fukuoka 1 , Hiroaki Tsuijita 1 , Shigeto Tsukamoto 1 , Toshiyuki Hayashi 2 , Tsutomu Toshida 1 , Norikazu Watanabe 1 , Yuji Hamazaki 1 , Eiichi Geshi 3 , Mikitaka Murakami 4 , Kazuo Aihara 5 , Koujin Kaneko 6 , Hirokazu Yamada 7, 8 , Youichi Kobayashi 1 , Toshiro Shinke 1
Affiliation  

Background:This prospective randomized multicenter open-label trial evaluated whether sodium-glucose cotransporter-2 inhibitor (SGLT2-i) improves left ventricular (LV) pump function and suppresses elevation of LV filling pressure (LVFP) and right ventricular systolic pressure (RVSP) during exercise in type 2 diabetes mellitus (T2DM) patients.

Methods and Results:Based on HbA1c and LV ejection fraction, 78 patients with poorly controlled T2DM were randomly assigned to D-group (dapagliflozin 5 mg/day add-on) or C-group (conventional therapy add-on). Physical examination, home and office blood pressure examination, blood tests, and echocardiography at rest and during ergometer exercise were performed at baseline and at 1.5 and 6 months after treatment. The primary endpoint was defined as the change in RVSP (mmHg) between baseline and 6-month follow up. The secondary endpoints were changes in LVFP (ratio), stroke volume index (SVi; mL/m2), and cardiac index (CI; L/min/m2). Both RVSP and LVFP during exercise significantly decreased from baseline to 6 months after starting treatment in the D-group (P<0.001). No changes to either parameter was observed in the C-group. The SVi and CI did not improve in either group. Both home and office blood pressure significantly decreased in the D-group. Decreases in HbA1c were somewhat greater in the C-group.

Conclusions:Dapagliflozin significantly improved RVSP and LVFP during exercise in patients with T2DM and cardiovascular risk, which may contribute to favorable effects on heart failure.



中文翻译:

Dapagliflozin 影响 2 型糖尿病患者的心室血流动力学和运动诱发的肺动脉高压 - 一项随机对照试验。

背景:这项前瞻性随机多中心开放标签试验评估了钠-葡萄糖协同转运蛋白 2 抑制剂 (SGLT2-i) 是否能改善左心室 (LV) 泵功能并抑制左心室充盈压 (LVFP) 和右心室收缩压 (RVSP) 的升高2 型糖尿病 (T2DM) 患者在运动期间。

方法和结果:根据 HbA1c 和 LV 射血分数,78 名控制不佳的 T2DM 患者被随机分配到 D 组(达格列净 5 mg/天附加)或 C 组(常规治疗附加)。在基线和治疗后 1.5 和 6 个月进行体格检查、家庭和办公室血压检查、血液检查和静息和测力计运动期间的超声心动图。主要终点定义为基线和 6 个月随访之间 RVSP (mmHg) 的变化。次要终点是 LVFP(比率)、每搏输出量指数(SVi;mL/m 2)和心脏指数(CI;L/min/m 2)。在 D 组开始治疗后 6 个月,运动期间的 RVSP 和 LVFP 均从基线显着降低(P<0.001)。在 C 组中没有观察到任何一个参数的变化。两组的 SVi 和 CI 均未改善。D组的家庭和办公室血压均显着降低。C 组中 HbA1c 的下降幅度更大一些。

结论:达格列净显着改善了 T2DM 和心血管风险患者在运动过程中的 RVSP 和 LVFP,这可能有助于对心力衰竭产生有利影响。

更新日期:2020-09-25
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