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Effect of levosimendan on the short-term clinical course of patients with acutely decompensated heart failure.

Author(s): Packer M(1), Colucci W(2), Fisher L(3), Massie BM(4), Teerlink JR(4), Young J(5), Padley RJ(6), Thakkar R(6), Delgado-Herrera L(6), Salon J(6), Garratt C(7), Huang B(6), Sarapohja T(7); REVIVE Heart Failure Study Group.

Collaborators: Packer M, Colucci W, Fisher L, Massie BM, Teerlink JR, Young J, Stevenson LW, O'Connor C, Fleming T, McMurray J, Wyse D, Kerr DR, Amerena JV, Atherton J, De Pasquale CG, Garrahy P, Harris PJ, Lattimore JD, Horowitz JD, Jeffery IM, Lo TH, McQuillan B, New G, Prior DL, Rees D, Sindone AP, Singh BB, Roberts-Thomson P, Tolfe GH, Walsh W, William M, Haddad H, Labonte R, Rajakumar A, Lotan C, Sieff R, Marmor A, Omary M, Reisin L, Vered Z, Zimlichman R, Abraham WT, Adamson PB, Alvarez R, Anand IS, Arroyo LH, Bailey JC, Bank AJ, Banish DH, Bart BA, Berk MR, Berkowitz RL, Berry BD, Bhalla RK, Bijou R, Bilsker M, Binkle PF, Boehmer JP, Bouchard A, Bourge RC, Browne KF Jr, Canaday DB, Chapman DB, Chu AA, Chung E, Clark DM, Colfer HT, Cooke RH, Czerska B, Cadaret L, DeNofrio D, Donohue TJ, Egbujiobi LC, Eichorn EJ, Elkayam U, Emlein G, Farahi JJ, Farhoud HH, Fernandez J, Fesniak HF, Fishbein DP, Fitzpatrick JT, Fontanet H, Garza L, Ghali JK, Goldstein J, Goodman LS, Gottlieb SS, Goulah RD, Greenspan MM, Gupta DK, Hager W, Harper SD, Hastings TE, Haught W, Hauptman PJ, Havranek EP, Hermann D, Heroux A, Herre JM, Hershberger RE, Hill DM, Hoagland PM, Howard VN Jr, Ishimori T, Iteld BJ, Jackson BK, Judge DP, Kalman J, Karlsberg RP, Katz R, Katz SD, Khalid M, Khan SS, Kim AY, Klapholz M, LeJemtel TH, Leonen MF, Levine DJ, Lui C, Maisel AS, Mann D, Mayer SA, McGrew FA 3rd, McLaughlin PJ, Miller LW, Mohiuddin SM, Murali S, Murray DR, Nallasivan M, Nicklas JM, Nisar A, Nwasuruba C, Orchard RC, Oren RM, Ouyang P, Parrott CW, Pauly DF, Perlmutter NS, Phillips DF, Pina IL, Promisloff S, Puma JA, Ratkovec RM, Reddy HK, Reeves RC, Roberts JS, Saltzberg MT, Sam F, Sarikonda K, Schmedtje JF Jr, Schrank JP, Schulyer G, Schwarz E, Scott B, Singh BB, Singh BN, Slawsky MT, Small RS, Stillabower ME, Tamburro PA, Teerlink JR, Thomas I, Torre-Amione G, Tsao L, Vicari RM, Vijayaraghavan K, Wagoner LE, Wainwright WR, Watkins MG, Wickemeyer WJ, Wiener DH, Yazji G, Young JB, Zimmer RR.

Affiliation(s): Author information: (1)Department of Clinical Sciences, University of Texas Medical Center at Dallas, Dallas, Texas. Electronic address: Milton.Packer@UTSouthwestern.edu. (2)Department of Medicine, Boston University School of Medicine, Boston, Massachusetts. (3)Department of Biostatistics, University of Washington, Seattle, Washington. (4)Department of Medicine, University of California at San Francisco and VA Medical Center, San Francisco, California. (5)Department of Medicine, Cleveland Clinic, Cleveland, Ohio. (6)Abbott Laboratories, Abbott Park, Illinois. (7)Orion Corporation, Orion Pharma, Espoo, Finland.

Publication date & source: 2013, JACC Heart Fail. , 1(2):103-11

BACKGROUND: This study evaluated the efficacy and safety of levosimendan, a positive inotropic drug with vasodilator effects, given intravenously to patients with acutely decompensated heart failure (ADHF). METHODS: We performed 2 sequential trials, the first to develop a new measure of efficacy in 100 patients, and the second to use this measure to evaluate levosimendan in an additional 600 patients. Patients admitted with ADHF received placebo or intravenous levosimendan for 24 h in addition to standard treatment. The primary endpoint was a composite that evaluated changes in clinical status during the first 5 days after randomization. RESULTS: In the 600-patient trial, more levosimendan than placebo patients (58 vs. 44) were improved at all 3 pre-specified time points (6 h, 24 h, and 5 days), whereas fewer levosimendan patients (58 vs. 82) experienced clinical worsening (p = 0.015 for the difference between the groups). These differences were apparent, despite more frequent intensification of adjunctive therapy in the placebo group (79 vs. 45 patients). Improvements in patient self-assessment and declines in B-type natriuretic peptide levels with levosimendan persisted for 5 days and were associated with reduced length of stay (p = 0.009). Similar findings were present in the 100-patient pilot trial. Levosimendan was associated with more frequent hypotension and cardiac arrhythmias during the infusion period and a numerically higher risk of death across the 2 trials (49 of 350 on a regimen of levosimendan vs. 40 of 350 on a regimen of placebo at 90 days, p = 0.29). CONCLUSIONS: In patients with ADHF, intravenous levosimendan provided rapid and durable symptomatic relief. As dosed in this trial, levosimendan was associated with an increased risk of adverse cardiovascular events. (Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure; NCT00048425).

Page last updated: 2014-11-30

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