A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure: The U.S. Ecadotril Pilot Safety Study

C. M. O'Connor, W. A. Gattis, M. Gheorghiade, C. B. Granger, J. Gilbert, J. M. McKenney, F. C. Messineo, John C Jr. Burnett, S. D. Katz, U. Elkayam, E. K. Kasper, S. Goldstein, R. J. Cody, B. M. Massie

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Objective: To determine the short-term safety and tolerability of the addition of ecadotril to conventional therapy in patients with mild to moderate heart failure. Methods: Fifty ambulatory patients, 18 to 75 years of age, with mild to moderate heart failure, left ventricular ejection fraction ≤35%, taking stable doses of angiotensin-converting enzyme inhibitor, diuretics, and optionally digoxin were enrolled in a randomized, double- blind, placebo-controlled dose-escalation study of ecadotril 50 to 400 mg twice daily versus conventional therapy alone. Results: No increases in deaths, serious adverse events, or dropouts from adverse events were observed for the ecadotril group compared with placebo. The serum measures of neurohormonal activation were highly variable. Changes in signs and symptoms of heart failure, New York Heart Association class, and patient self- assessment of symptoms were not observed with ecadotril therapy; however, the study was not designed to detect differences in these parameters. Conclusion: In this small pilot study, ecadotril in doses of 50 to 400 mg twice daily was generally well-tolerated and without severe short-term adverse effects in patients with mild to moderate heart failure. Evaluation of the clinical efficacy and long-term safety of ecadotril and other neutral endopeptidase inhibitors in patients with heart failure requires further study.

Original languageEnglish (US)
Pages (from-to)1140-1148
Number of pages9
JournalAmerican Heart Journal
Volume138
Issue number6 I
StatePublished - 1999
Externally publishedYes

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Heart Failure
Placebos
Safety
Neprilysin
Digoxin
Protease Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Diuretics
Stroke Volume
Signs and Symptoms
racecadotril
Therapeutics
Serum

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

O'Connor, C. M., Gattis, W. A., Gheorghiade, M., Granger, C. B., Gilbert, J., McKenney, J. M., ... Massie, B. M. (1999). A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure: The U.S. Ecadotril Pilot Safety Study. American Heart Journal, 138(6 I), 1140-1148.

A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure : The U.S. Ecadotril Pilot Safety Study. / O'Connor, C. M.; Gattis, W. A.; Gheorghiade, M.; Granger, C. B.; Gilbert, J.; McKenney, J. M.; Messineo, F. C.; Burnett, John C Jr.; Katz, S. D.; Elkayam, U.; Kasper, E. K.; Goldstein, S.; Cody, R. J.; Massie, B. M.

In: American Heart Journal, Vol. 138, No. 6 I, 1999, p. 1140-1148.

Research output: Contribution to journalArticle

O'Connor, CM, Gattis, WA, Gheorghiade, M, Granger, CB, Gilbert, J, McKenney, JM, Messineo, FC, Burnett, JCJ, Katz, SD, Elkayam, U, Kasper, EK, Goldstein, S, Cody, RJ & Massie, BM 1999, 'A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure: The U.S. Ecadotril Pilot Safety Study', American Heart Journal, vol. 138, no. 6 I, pp. 1140-1148.
O'Connor CM, Gattis WA, Gheorghiade M, Granger CB, Gilbert J, McKenney JM et al. A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure: The U.S. Ecadotril Pilot Safety Study. American Heart Journal. 1999;138(6 I):1140-1148.
O'Connor, C. M. ; Gattis, W. A. ; Gheorghiade, M. ; Granger, C. B. ; Gilbert, J. ; McKenney, J. M. ; Messineo, F. C. ; Burnett, John C Jr. ; Katz, S. D. ; Elkayam, U. ; Kasper, E. K. ; Goldstein, S. ; Cody, R. J. ; Massie, B. M. / A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure : The U.S. Ecadotril Pilot Safety Study. In: American Heart Journal. 1999 ; Vol. 138, No. 6 I. pp. 1140-1148.
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abstract = "Objective: To determine the short-term safety and tolerability of the addition of ecadotril to conventional therapy in patients with mild to moderate heart failure. Methods: Fifty ambulatory patients, 18 to 75 years of age, with mild to moderate heart failure, left ventricular ejection fraction ≤35{\%}, taking stable doses of angiotensin-converting enzyme inhibitor, diuretics, and optionally digoxin were enrolled in a randomized, double- blind, placebo-controlled dose-escalation study of ecadotril 50 to 400 mg twice daily versus conventional therapy alone. Results: No increases in deaths, serious adverse events, or dropouts from adverse events were observed for the ecadotril group compared with placebo. The serum measures of neurohormonal activation were highly variable. Changes in signs and symptoms of heart failure, New York Heart Association class, and patient self- assessment of symptoms were not observed with ecadotril therapy; however, the study was not designed to detect differences in these parameters. Conclusion: In this small pilot study, ecadotril in doses of 50 to 400 mg twice daily was generally well-tolerated and without severe short-term adverse effects in patients with mild to moderate heart failure. Evaluation of the clinical efficacy and long-term safety of ecadotril and other neutral endopeptidase inhibitors in patients with heart failure requires further study.",
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AU - Gheorghiade, M.

AU - Granger, C. B.

AU - Gilbert, J.

AU - McKenney, J. M.

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AU - Kasper, E. K.

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