急性心力衰竭中的克利地平：急性心力衰竭血压控制研究（PRONTO）的结果-一项初步研究。

Clevidipine in acute heart failure: Results of the A Study of Blood Pressure Control in Acute Heart Failure-A Pilot Study (PRONTO).

机构信息

Baylor College of Medicine, Houston, TX.

Duke University, Durham, NC.

出版信息

Am Heart J. 2014 Apr;167(4):529-36. doi: 10.1016/j.ahj.2013.12.023. Epub 2014 Jan 15.

DOI:10.1016/j.ahj.2013.12.023

PMID:24655702

Abstract

BACKGROUND

Rapid blood pressure (BP) control improves dyspnea in hypertensive acute heart failure (AHF). Although effective antihypertensives, calcium-channel blockers are poorly studied in AHF. Clevidipine is a rapidly acting, arterial selective intravenous calcium-channel blocker. Our purpose was to determine the efficacy and safety of clevidipine vs standard-of-care intravenous antihypertensive therapy (SOC) in hypertensive AHF.

METHODS

This is a randomized, open-label, active control study of clevidipine vs SOC in emergency department patients with AHF having systolic BP ≥160 mm Hg and dyspnea ≥50 on a 100-mm visual analog scale (VAS). Coprimary end points were median time to, and percent attaining, a systolic BP within a prespecified target BP range (TBPR) at 30 minutes. Dyspnea reduction was the main secondary end point.

RESULTS

Of 104 patients (mean [SD] age 61 [14.9] years, 52% female, 80% African American), 51 received clevidipine and 53 received SOC. Baseline mean (SD) systolic BP and VAS dyspnea were 186.5 (23.4) mm Hg and 64.8 (19.6) mm. More clevidipine patients (71%) reached TBPR than did those receiving SOC (37%; P = .002), and clevidipine was faster to TBPR (P = .0006). At 45 minutes, clevidipine patients had greater mean (SD) VAS dyspnea improvement than did SOC patients (-37 [20.9] vs -28 mm [21.7], P = .02), a difference that remained significant up to 3 hours. Serious adverse events (24% vs 19%) and 30-day mortality (3 vs 2) were similar between clevedipine and SOC, respectively, and there were no deaths during study drug administration.

CONCLUSIONS

In hypertensive AHF, clevidipine safely and rapidly reduces BP and improves dyspnea more effectively than SOC.

摘要

背景

快速降压可改善高血压急性心力衰竭（AHF）患者的呼吸困难。虽然钙通道阻滞剂是有效的降压药，但在 AHF 中的研究较少。Clevidipine 是一种起效迅速、动脉选择性的静脉用钙通道阻滞剂。我们的目的是确定 clevidipine 与标准降压治疗（SOC）在高血压性 AHF 中的疗效和安全性。

方法

这是一项在急诊科中进行的随机、开放标签、阳性对照研究，纳入了收缩压≥160mmHg 且呼吸困难视觉模拟量表（VAS）评分≥50 的 AHF 患者，比较 clevidipine 与 SOC 的疗效。主要终点为 30 分钟时达到预设目标血压范围（TBPR）的中位时间和达到目标血压范围的百分比。呼吸困难缓解是主要次要终点。

结果

共纳入 104 例患者（平均年龄 61 [14.9]岁，52%为女性，80%为非裔美国人），51 例接受 clevidipine 治疗，53 例接受 SOC 治疗。基线时平均（标准差）收缩压和 VAS 呼吸困难评分为 186.5（23.4）mmHg 和 64.8（19.6）mm。接受 clevidipine 治疗的患者达到 TBPR 的比例（71%）高于接受 SOC 治疗的患者（37%；P=0.002），达到 TBPR 的速度更快（P=0.0006）。在 45 分钟时，clevidipine 组的 VAS 呼吸困难改善均值（标准差）大于 SOC 组（-37 [20.9] vs -28mm [21.7]，P=0.02），该差异在 3 小时时仍有统计学意义。严重不良事件（24% vs 19%）和 30 天死亡率（3 例 vs 2 例）在 clevidipine 组和 SOC 组之间相似，研究药物治疗期间无死亡。