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

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

Peacock WF, Chandra A, Char D, Collins S, Der Sahakian G, Ding L, Dunbar L, Fermann G, Fonarow GC, Garrison N, Hu MY, Jourdain P, Laribi S, Levy P, Möckel M, Mueller C, Ray P, Singer A, Ventura H, Weiss M, Mebazaa A. Am Heart J. 2014 Apr;167(4):529-36.

Author information :

  • 1Baylor College of Medicine, Houston, TX. Electronic address: frankpeacock@gmail.com.
  • 2Duke University, Durham, NC.
  • 3Washington University, St. Louis, MO.
  • 4Vanderbilt University, Nashville, TN.
  • 5Université Paris V, Paris, France.
  • 6The Medicine’s Company, Parsippany, NJ.
  • 7Louisiana Health Sciences Center, New Orleans, LA.
  • 8University of Cincinnati, Cincinnati, OH.
  • 9University of California Los Angeles, Los Angeles, CA.
  • 10Jackson Hospital, Jackson, MS.
  • 11Rene Dubos Hospital, Pontoise, France.
  • 12Université Paris Diderot and Hospital Lariboisière, Paris, France.
  • 13Detroit Receiving Hospital, Detroit, MI.
  • 14Charite Hospital, Berlin, Germany.
  • 15University Hospital Basel, Basel, Switzerland.
  • 16Tenon Hospital, University of Paris, Paris, France.
  • 17Stonybrook University, Stonybrook, NY.
  • 18Oschner Medical Center, Jefferson, LA.
  • 19Centinela Hospital Medical Center, Inglewood, CA.

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.

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