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

Peacock, W Frank; Chandra, Abhinav; Char, Douglas; Collins, Sean; Der Sahakian, Guillaume; Ding, Li; Dunbar, Lala; Fermann, Gregory; Fonarow, Gregg C; Garrison, Norman; Hu, Ming-Yi; Jourdain, Patrick; Laribi, Said; Levy, Phillip; Möckel, Martin; Mueller, Christian; Ray, Patrick; Singer, Adam; Ventura, Hector; Weiss, Mason; Mebazaa, Alex.
Am Heart J; 167(4): 529-36, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24655702

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.
Selo DaSilva