A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial.
A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial.
复制标题
DOI：
10.1093/eurheartj/ehaa419
复制
发表时间：
2020-09-21
影响因子：
39.3
通讯作者：
Lang CC
中科院分区：
文献类型：
--
作者：
Brown AJM;Gandy S;McCrimmon R;Houston JG;Struthers AD;Lang CC
我们检验了达格列净可能缓解2型糖尿病（T2D）患者左心室肥厚（LVH）的假设。我们随机分配66例（平均年龄67±7岁，男性38例）患有T2D、LVH和控制血压（BP）的患者接受达格列净10mg每日1次或安慰剂治疗12个月。主要终点是通过心脏磁共振成像评估的绝对左心室质量（LVM）的变化。在意向治疗分析中，与安慰剂相比，达格列净显著降低了LVM，绝对平均变化为- 2.82g[95%置信区间（CI）： - 5.13至- 0.51,P = 0.018]。另外对基线LVM、基线血压、体重和收缩压变化进行敏感性分析，结果显示LVM变化仍然具有统计学意义（平均变化- 2.92g; 95% CI: - 5.45至- 0.38,P = 0.025）。达格列净显著降低了预先指定的次要终点，包括动态24小时收缩压（P = 0.012）、夜间收缩压（P = 0.017）、体重（P < 0.001）、内脏脂肪组织（VAT） （P < 0.001）、皮下脂肪组织（SCAT） （P = 0.001）、胰岛素抵抗、胰岛素抵抗稳态模型评估（P = 0.017）和高敏c反应蛋白（hsCRP） （P = 0.049）。达格列净治疗可显著降低T2D和LVH患者的LVM。LVM的降低伴随着收缩压、体重、内脏和SCAT、胰岛素抵抗和hsCRP的降低。LVM的回归表明，达格列净可以启动左心室结构的反向重构和改变，这可能部分有助于达格列净的心脏保护作用。NCT02956811
We tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with type 2 diabetes (T2D). We randomly assigned 66 people (mean age 67 ± 7 years, 38 males) with T2D, LVH, and controlled blood pressure (BP) to receive dapagliflozin 10 mg once daily or placebo for 12 months. Primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging. In the intention-to-treat analysis, dapagliflozin significantly reduced LVM compared with placebo with an absolute mean change of −2.82g [95% confidence interval (CI): −5.13 to −0.51, P = 0.018]. Additional sensitivity analysis adjusting for baseline LVM, baseline BP, weight, and systolic BP change showed the LVM change to remain statistically significant (mean change −2.92g; 95% CI: −5.45 to −0.38, P = 0.025). Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h systolic BP (P = 0.012), nocturnal systolic BP (P = 0.017), body weight (P < 0.001), visceral adipose tissue (VAT) (P < 0.001), subcutaneous adipose tissue (SCAT) (P = 0.001), insulin resistance, Homeostatic Model Assessment of Insulin Resistance (P = 0.017), and high-sensitivity C-reactive protein (hsCRP) (P = 0.049). Dapagliflozin treatment significantly reduced LVM in people with T2D and LVH. This reduction in LVM was accompanied by reductions in systolic BP, body weight, visceral and SCAT, insulin resistance, and hsCRP. The regression of LVM suggests dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to the cardio-protective effects of dapagliflozin. NCT02956811
登录
查看更多内容
影响因子：
5.8
作者：
Bolinder, J.;Ljunggren, O.;Parikh, S.
通讯作者：
Parikh, S.
影响因子：
8.2
作者：
Dawson, A;Morris, AD;Struthers, AD
通讯作者：
Struthers, AD
影响因子：
37.8
作者：
Abraham TM;Pedley A;Massaro JM;Hoffmann U;Fox CS
通讯作者：
Fox CS
影响因子：
37.8
作者：
Devereux, RB;Dahlöf, B;Wachtell, K
通讯作者：
Wachtell, K
影响因子：
6.2
作者：
Lang, Roberto M.;Badano, Luigi P.;Voigt, Jens-Uwe
通讯作者：
Voigt, Jens-Uwe