title: Clevidipine in acute heart failure: Results of the A Study of Blood Pressure Control in Acute Heart Failure-A Pilot Study (PRONTO).
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.
authors.affiliation: Baylor College of Medicine, Houston, TX. Electronic address: frankpeacock@gmail.com.
authors.forename: W Frank
authors.initials: WF
authors.lastname: Peacock
authors.affiliation: Duke University, Durham, NC.
authors.forename: Abhinav
authors.initials: A
authors.lastname: Chandra
authors.affiliation: Washington University, St. Louis, MO.
authors.forename: Douglas
authors.initials: D
authors.lastname: Char
authors.affiliation: Vanderbilt University, Nashville, TN.
authors.forename: Sean
authors.initials: S
authors.lastname: Collins
authors.affiliation: Université Paris V, Paris, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Der Sahakian
authors.affiliation: The Medicine's Company, Parsippany, NJ.
authors.forename: Li
authors.initials: L
authors.lastname: Ding
authors.affiliation: Louisiana Health Sciences Center, New Orleans, LA.
authors.forename: Lala
authors.initials: L
authors.lastname: Dunbar
authors.affiliation: University of Cincinnati, Cincinnati, OH.
authors.forename: Gregory
authors.initials: G
authors.lastname: Fermann
authors.affiliation: University of California Los Angeles, Los Angeles, CA.
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: Jackson Hospital, Jackson, MS.
authors.forename: Norman
authors.initials: N
authors.lastname: Garrison
authors.affiliation: The Medicine's Company, Parsippany, NJ.
authors.forename: Ming-Yi
authors.initials: MY
authors.lastname: Hu
authors.affiliation: Rene Dubos Hospital, Pontoise, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Jourdain
authors.affiliation: Université Paris Diderot and Hospital Lariboisière, Paris, France.
authors.forename: Said
authors.initials: S
authors.lastname: Laribi
authors.affiliation: Detroit Receiving Hospital, Detroit, MI.
authors.forename: Phillip
authors.initials: P
authors.lastname: Levy
authors.affiliation: Charite Hospital, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Möckel
authors.affiliation: University Hospital Basel, Basel, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Mueller
authors.affiliation: Tenon Hospital, University of Paris, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ray
authors.affiliation: Stonybrook University, Stonybrook, NY.
authors.forename: Adam
authors.initials: A
authors.lastname: Singer
authors.affiliation: Oschner Medical Center, Jefferson, LA.
authors.forename: Hector
authors.initials: H
authors.lastname: Ventura
authors.affiliation: Centinela Hospital Medical Center, Inglewood, CA.
authors.forename: Mason
authors.initials: M
authors.lastname: Weiss
authors.affiliation: Université Paris Diderot and Hospital Lariboisière, Paris, France.
authors.forename: Alex
authors.initials: A
authors.lastname: Mebazaa
mesh_terms: D000208:Acute Disease; D001794:Blood Pressure / Q000187:drug effects*; D001795:Blood Pressure Determination / Q000379:methods*; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D002121:Calcium Channel Blockers; D011725:Pyridines; C118563:clevidipine