W Frank Peacock1, Abhinav Chandra2, Douglas Char3, Sean Collins4, Guillaume Der Sahakian5, Li Ding6, Lala Dunbar7, Gregory Fermann8, Gregg C Fonarow9, Norman Garrison10, Ming-Yi Hu6, Patrick Jourdain11, Said Laribi12, Phillip Levy13, Martin Möckel14, Christian Mueller15, Patrick Ray16, Adam Singer17, Hector Ventura18, Mason Weiss19, Alex Mebazaa12. 1. Baylor College of Medicine, Houston, TX. Electronic address: frankpeacock@gmail.com. 2. Duke University, Durham, NC. 3. Washington University, St. Louis, MO. 4. Vanderbilt University, Nashville, TN. 5. Université Paris V, Paris, France. 6. The Medicine's Company, Parsippany, NJ. 7. Louisiana Health Sciences Center, New Orleans, LA. 8. University of Cincinnati, Cincinnati, OH. 9. University of California Los Angeles, Los Angeles, CA. 10. Jackson Hospital, Jackson, MS. 11. Rene Dubos Hospital, Pontoise, France. 12. Université Paris Diderot and Hospital Lariboisière, Paris, France. 13. Detroit Receiving Hospital, Detroit, MI. 14. Charite Hospital, Berlin, Germany. 15. University Hospital Basel, Basel, Switzerland. 16. Tenon Hospital, University of Paris, Paris, France. 17. Stonybrook University, Stonybrook, NY. 18. Oschner Medical Center, Jefferson, LA. 19. Centinela 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.
RCT Entities:
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 clevidipinepatients (71%) reached TBPR than did those receiving SOC (37%; P = .002), and clevidipine was faster to TBPR (P = .0006). At 45 minutes, clevidipinepatients 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.