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两种格列净类药物是否不同:一项前瞻性多中心随机研究,旨在评估瑞格列净与恩格列净对患有慢性心力衰竭的印度2型糖尿病患者心力衰竭生物标志物的影响(REMIT-HF研究)。

Are Two Gliflozins Different: A Prospective Multicenter Randomized Study to Assess Effect of Remogliflozin Compared With Empagliflozin on Biomarkers of Heart Failure in Indian Patients With Type 2 Diabetes Mellitus with Chronic Heart Failure (REMIT-HF Study).

作者信息

Sengupta Shantanu, Pathiyilbalagopalan Jayagopal, Mehta Ashwani, Sawhney J P S, Suryavanshi Satish, Jamwal Naveen, Kadam Dilip, Gowda Ambanna, Dargad Ramesh, Bhate Amit, Kapoor Vinod, Bhushan Sumit, Mane Abhishek, Gadkari Rujuta, Patil Saiprasad, Barkate Hanmant

机构信息

Sengupta Hospital and Research Institute, Nagpur, India.

Lakshmi Hospital, Palakkad, India.

出版信息

J Card Fail. 2025 Jan;31(1):158-162. doi: 10.1016/j.cardfail.2024.07.020. Epub 2024 Aug 14.

DOI:10.1016/j.cardfail.2024.07.020
PMID:39151723
Abstract

There is limited data comparing two gliflozins on their effect on biomarkers in diabetic patients with chronic heart failure. A prospective, multicenter, active controlled, double-arm, investigator-initiated, interventional study enrolled 250 adults with type 2 diabetes mellitus (T2DM) and comorbid congestive heart failure (CHF; left ventricular ejection fraction [LVEF] <40%; N-terminal pro-B-type natriuretic peptide [NT-proBNP] >600 pg/mL). A total of 125 patients were allocated each to a remogliflozin (R) and empagliflozin (E) group and followed up for 24 weeks. The primary endpoint was the mean percentage change from baseline in NT-proBNP level after 24 weeks. There was significant improvement from baseline in mean NT-proBNP level in both groups after 24 weeks. However, there was no significant difference between the two groups (P = .214). The mean NT-proBNP level improved from 2078.15 ± 1764.70 pg/mL at baseline to 1185.06 ± 1164.21 pg/mL at 6 months in the R-group (P ≤ .001) and from 2283.98 ± 1759.15 pg/mL at baseline to 1395.33 ± 1304.18 pg/mL at 6 months in the E-group (P < .001). LVEF and LV volumes improved in both groups. The glycemic parameters (HbA1c, FPG, and PPG) demonstrated a significant reduction from baseline to week 24 in both groups. Similar improvement was seen in heart rate, blood pressure, and weight reduction over 6 months in both groups. There was no drug-related serious adverse events in any group. Remogliflozin and empagliflozin significantly improve glycemic parameters and NT-proBNP levels as the index of the therapeutic effects in T2DM patients with CHF. The positive effects are comparable in both groups.

摘要

关于两种格列净类药物对合并慢性心力衰竭的糖尿病患者生物标志物影响的比较数据有限。一项前瞻性、多中心、活性对照、双臂、研究者发起的干预性研究纳入了250名2型糖尿病(T2DM)合并充血性心力衰竭(CHF;左心室射血分数[LVEF]<40%;N末端B型利钠肽原[NT-proBNP]>600 pg/mL)的成年人。总共125名患者被分别分配到瑞格列净(R)组和恩格列净(E)组,并随访24周。主要终点是24周后NT-proBNP水平相对于基线的平均百分比变化。24周后两组的平均NT-proBNP水平相对于基线均有显著改善。然而,两组之间没有显著差异(P = 0.214)。R组的平均NT-proBNP水平从基线时的2078.15±1764.70 pg/mL改善至6个月时的1185.06±1164.21 pg/mL(P≤0.001),E组从基线时的2283.98±1759.15 pg/mL改善至6个月时的1395.33±1304.18 pg/mL(P<0.001)。两组的LVEF和左心室容积均有所改善。两组的血糖参数(糖化血红蛋白、空腹血糖和餐后血糖)从基线至第24周均显著降低。两组在6个月内的心率、血压和体重减轻方面也有类似改善。任何一组均未出现与药物相关的严重不良事件。瑞格列净和恩格列净可显著改善血糖参数和NT-proBNP水平,作为CHF合并T2DM患者治疗效果的指标。两组的积极效果相当。

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Are Two Gliflozins Different: A Prospective Multicenter Randomized Study to Assess Effect of Remogliflozin Compared With Empagliflozin on Biomarkers of Heart Failure in Indian Patients With Type 2 Diabetes Mellitus with Chronic Heart Failure (REMIT-HF Study).两种格列净类药物是否不同:一项前瞻性多中心随机研究,旨在评估瑞格列净与恩格列净对患有慢性心力衰竭的印度2型糖尿病患者心力衰竭生物标志物的影响(REMIT-HF研究)。
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