Journal article
Clevidipine in acute heart failure: Results of the A Study of Blood Pressure Control in Acute Heart Failure-A Pilot Study (PRONTO).
- Peacock WF Baylor College of Medicine, Houston, TX. Electronic address: frankpeacock@gmail.com.
- Chandra A Duke University, Durham, NC.
- Char D Washington University, St. Louis, MO.
- Collins S Vanderbilt University, Nashville, TN.
- Der Sahakian G Université Paris V, Paris, France.
- Ding L The Medicine's Company, Parsippany, NJ.
- Dunbar L Louisiana Health Sciences Center, New Orleans, LA.
- Fermann G University of Cincinnati, Cincinnati, OH.
- Fonarow GC University of California Los Angeles, Los Angeles, CA.
- Garrison N Jackson Hospital, Jackson, MS.
- Hu MY The Medicine's Company, Parsippany, NJ.
- Jourdain P Rene Dubos Hospital, Pontoise, France.
- Laribi S Université Paris Diderot and Hospital Lariboisière, Paris, France.
- Levy P Detroit Receiving Hospital, Detroit, MI.
- Möckel M Charite Hospital, Berlin, Germany.
- Mueller C University Hospital Basel, Basel, Switzerland.
- Ray P Tenon Hospital, University of Paris, Paris, France.
- Singer A Stonybrook University, Stonybrook, NY.
- Ventura H Oschner Medical Center, Jefferson, LA.
- Weiss M Centinela Hospital Medical Center, Inglewood, CA.
- Mebazaa A Université Paris Diderot and Hospital Lariboisière, Paris, France.
- 2014-03-25
Published in:
- American heart journal. - 2014
Acute Disease
Blood Pressure
Blood Pressure Determination
Calcium Channel Blockers
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Heart Failure
Humans
Infusions, Intravenous
Male
Middle Aged
Pilot Projects
Prospective Studies
Pyridines
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.ahj.2013.12.023
- PMID 24655702
- Persistent URL
- https://sonar.ch/global/documents/232258
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