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: 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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Authors | C M O'Connor, W A Gattis, M Gheorghiade, C B Granger, J Gilbert, J M McKenney, F C Messineo, J C Burnett, S D Katz, U Elkayam, E K Kasper, S Goldstein, R J Cody, B M Massie |
Journal | American heart journal
(Am Heart J)
Vol. 138
Issue 6 Pt 1
Pg. 1140-8
(Dec 1999)
ISSN: 0002-8703 [Print] United States |
PMID | 10577446
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Prodrugs
- racecadotril
- Thiorphan
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Topics |
- Adolescent
- Adult
- Aged
- Double-Blind Method
- Female
- Heart Failure
(drug therapy)
- Humans
- Male
- Middle Aged
- Pilot Projects
- Prodrugs
(therapeutic use)
- Severity of Illness Index
- Thiorphan
(analogs & derivatives, therapeutic use)
- Time Factors
- Treatment Outcome
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