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

被引:17
作者
O'Connor, CM
Gattis, WA
Gheorghiade, M
Granger, CB
Gilbert, J
McKenney, JM
Messineo, FC
Burnett, JC
Katz, SD
Elkayam, U
Kasper, EK
Goldstein, S
Cody, RJ
Massie, BM
机构
[1] Duke Univ, Med Ctr, Durham, NC 27710 USA
[2] Northwestern Univ, Chicago, IL 60611 USA
[3] Bayer Corp, W Haven, CT USA
[4] Virginia Commonwealth Univ, Med Coll Virginia, Richmond, VA 23298 USA
[5] Univ Connecticut, Ctr Hlth, Farmington, CT USA
[6] Mayo Clin & Mayo Fdn, Rochester, MN 55905 USA
[7] Univ So Calif, Los Angeles, CA USA
[8] Columbia Univ, New York, NY USA
[9] Johns Hopkins Univ Hosp, Baltimore, MD 21205 USA
[10] Henry Ford Hosp, Detroit, MI 48202 USA
[11] Ohio State Univ, Med Ctr, Columbus, OH 43210 USA
[12] Vet Affairs Med Ctr, San Francisco, CA 94121 USA
关键词
D O I
10.1016/S0002-8703(99)70081-5
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 election fraction less than or equal to 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.
引用
收藏
页码:1140 / 1148
页数:9
相关论文
共 16 条
  • [11] Neutral endopeptidase 24.11 inhibition may neat exhibit beneficial haemodynamic effects in patients with congestive heart failure
    Kentsch, M
    Otter, W
    Drummer, C
    Notges, A
    Gerzer, R
    MullerEsch, G
    [J]. EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 1996, 51 (3-4) : 269 - 272
  • [12] Effects of renal neutral endopeptidase inhibition on sodium excretion, renal hemodynamics and neurohormonal activation in patients with congestive heart failure
    Kimmelstiel, CD
    Perrone, R
    Kilcoyne, L
    Souhrada, J
    Udelson, J
    Smith, J
    deBold, A
    Griffith, J
    Konstam, MA
    [J]. CARDIOLOGY, 1996, 87 (01) : 46 - 53
  • [13] The effect of the neutral endopeptidase inhibitor drug, candoxatril, on circulating levels of two of the most potent vasoactive peptides
    McDowell, G
    Coutie, W
    Shaw, C
    Buchanan, KD
    Struthers, AD
    Nicholls, DP
    [J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 1997, 43 (03) : 329 - 332
  • [14] Wegner M, 1996, CARDIOVASC RES, V31, P891
  • [15] NATRIURETIC PEPTIDE SYSTEM IN HUMAN HEART-FAILURE
    WEI, CM
    HEUBLEIN, DM
    PERRELLA, MA
    LERMAN, A
    RODEHEFFER, RJ
    MCGREGOR, CGA
    EDWARDS, WD
    SCHAFF, HV
    BURNETT, JC
    [J]. CIRCULATION, 1993, 88 (03) : 1004 - 1009
  • [16] The natriuretic-peptide family
    Wilkins, MR
    Redondo, J
    Brown, LA
    [J]. LANCET, 1997, 349 (9061) : 1307 - 1310