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Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure.

Publication ,  Journal Article
Teerlink, JR; Diaz, R; Felker, GM; McMurray, JJV; Metra, M; Solomon, SD; Adams, KF; Anand, I; Arias-Mendoza, A; Biering-Sørensen, T; Böhm, M ...
Published in: N Engl J Med
January 14, 2021

BACKGROUND: The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS: We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS: During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016-002299-28.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

January 14, 2021

Volume

384

Issue

2

Start / End Page

105 / 116

Location

United States

Related Subject Headings

  • Urea
  • Stroke Volume
  • Myocardial Contraction
  • Middle Aged
  • Male
  • Humans
  • Heart Failure, Systolic
  • General & Internal Medicine
  • Female
  • Cardiovascular Diseases
 

Citation

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Teerlink, J. R., Diaz, R., Felker, G. M., McMurray, J. J. V., Metra, M., Solomon, S. D., … GALACTIC-HF Investigators, . (2021). Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med, 384(2), 105–116. https://doi.org/10.1056/NEJMoa2025797
Teerlink, John R., Rafael Diaz, G Michael Felker, John J. V. McMurray, Marco Metra, Scott D. Solomon, Kirkwood F. Adams, et al. “Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure.N Engl J Med 384, no. 2 (January 14, 2021): 105–16. https://doi.org/10.1056/NEJMoa2025797.
Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, et al. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105–16.
Teerlink, John R., et al. “Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure.N Engl J Med, vol. 384, no. 2, Jan. 2021, pp. 105–16. Pubmed, doi:10.1056/NEJMoa2025797.
Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sørensen T, Böhm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlström U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura S-I, O’Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE, GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105–116.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

January 14, 2021

Volume

384

Issue

2

Start / End Page

105 / 116

Location

United States

Related Subject Headings

  • Urea
  • Stroke Volume
  • Myocardial Contraction
  • Middle Aged
  • Male
  • Humans
  • Heart Failure, Systolic
  • General & Internal Medicine
  • Female
  • Cardiovascular Diseases