Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure

J. R. Hampton, D. J. Van Veldhuisen, F. X. Kleber, A. J. Cowley, A. Ardia, P. Block, A. Cortina, L. Cserhalmi, F. Follath, G. Jensen, J. Kayanakis, K. I. Lie, G. Mancia, A. M. Skene

Research output: Contribution to journalArticle

300 Citations (Scopus)

Abstract

Background: Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. We assessed the effect of ibopamine on survival in patients with advanced heart failure in a multicentre, randomised placebo-controlled study. Methods: Patients with advanced severe heart failure (New York Heart Association classes III and IV) and evidence of severe left-ventricular disease, who were already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The primary endpoint was all-cause mortality. The study was designed to recruit 2200 patients, and the minimum duration of treatment would be 6 months. We did intention-to-treat and on-treatment analyses; a post-hoc subgroup analysis was also done. Findings: After we had recruited 1906 patients the trial was stopped early, because of an excess of deaths among patients in the ibopamine group. 232 (25%) of 953 patients in the ibopamine group died, compared with 193 (20%) of 953 patients in the placebo group (relative risk 1-26 [95% CI 1.04-1.53], p = 0.017). The average length of follow-up was 347 days in the ibopamine group and 363 days in the placebo group. In multivariate analysis, only the use of antiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients. Interpretation: Ibopamine seems to increase the risk of death among patients with advanced heart failure who are already receiving optimum therapy, but the reasons for this increase are not clear. Our finding that antiarrhythmic treatment was a significant predictor of increased mortality in ibopamine-treated patients may be important, but exploratory analyses must be interpreted with caution.

Original languageEnglish
Pages (from-to)971-977
Number of pages7
JournalLancet
Volume349
Issue number9057
DOIs
Publication statusPublished - Apr 5 1997

Fingerprint

Heart Failure
Survival
Placebos
ibopamine
Mortality
Anti-Arrhythmia Agents
Therapeutics
Treatment Failure
Vasodilation
Pharmaceutical Preparations
Multivariate Analysis
Kidney

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hampton, J. R., Van Veldhuisen, D. J., Kleber, F. X., Cowley, A. J., Ardia, A., Block, P., ... Skene, A. M. (1997). Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. Lancet, 349(9057), 971-977. https://doi.org/10.1016/S0140-6736(96)10488-8

Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. / Hampton, J. R.; Van Veldhuisen, D. J.; Kleber, F. X.; Cowley, A. J.; Ardia, A.; Block, P.; Cortina, A.; Cserhalmi, L.; Follath, F.; Jensen, G.; Kayanakis, J.; Lie, K. I.; Mancia, G.; Skene, A. M.

In: Lancet, Vol. 349, No. 9057, 05.04.1997, p. 971-977.

Research output: Contribution to journalArticle

Hampton, JR, Van Veldhuisen, DJ, Kleber, FX, Cowley, AJ, Ardia, A, Block, P, Cortina, A, Cserhalmi, L, Follath, F, Jensen, G, Kayanakis, J, Lie, KI, Mancia, G & Skene, AM 1997, 'Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure', Lancet, vol. 349, no. 9057, pp. 971-977. https://doi.org/10.1016/S0140-6736(96)10488-8
Hampton JR, Van Veldhuisen DJ, Kleber FX, Cowley AJ, Ardia A, Block P et al. Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. Lancet. 1997 Apr 5;349(9057):971-977. https://doi.org/10.1016/S0140-6736(96)10488-8
Hampton, J. R. ; Van Veldhuisen, D. J. ; Kleber, F. X. ; Cowley, A. J. ; Ardia, A. ; Block, P. ; Cortina, A. ; Cserhalmi, L. ; Follath, F. ; Jensen, G. ; Kayanakis, J. ; Lie, K. I. ; Mancia, G. ; Skene, A. M. / Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. In: Lancet. 1997 ; Vol. 349, No. 9057. pp. 971-977.
@article{8640fde7d70d44bfb03d6f20012895a3,
title = "Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure",
abstract = "Background: Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. We assessed the effect of ibopamine on survival in patients with advanced heart failure in a multicentre, randomised placebo-controlled study. Methods: Patients with advanced severe heart failure (New York Heart Association classes III and IV) and evidence of severe left-ventricular disease, who were already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The primary endpoint was all-cause mortality. The study was designed to recruit 2200 patients, and the minimum duration of treatment would be 6 months. We did intention-to-treat and on-treatment analyses; a post-hoc subgroup analysis was also done. Findings: After we had recruited 1906 patients the trial was stopped early, because of an excess of deaths among patients in the ibopamine group. 232 (25{\%}) of 953 patients in the ibopamine group died, compared with 193 (20{\%}) of 953 patients in the placebo group (relative risk 1-26 [95{\%} CI 1.04-1.53], p = 0.017). The average length of follow-up was 347 days in the ibopamine group and 363 days in the placebo group. In multivariate analysis, only the use of antiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients. Interpretation: Ibopamine seems to increase the risk of death among patients with advanced heart failure who are already receiving optimum therapy, but the reasons for this increase are not clear. Our finding that antiarrhythmic treatment was a significant predictor of increased mortality in ibopamine-treated patients may be important, but exploratory analyses must be interpreted with caution.",
author = "Hampton, {J. R.} and {Van Veldhuisen}, {D. J.} and Kleber, {F. X.} and Cowley, {A. J.} and A. Ardia and P. Block and A. Cortina and L. Cserhalmi and F. Follath and G. Jensen and J. Kayanakis and Lie, {K. I.} and G. Mancia and Skene, {A. M.}",
year = "1997",
month = "4",
day = "5",
doi = "10.1016/S0140-6736(96)10488-8",
language = "English",
volume = "349",
pages = "971--977",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Lancet Publishing Group",
number = "9057",

}

TY - JOUR

T1 - Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure

AU - Hampton, J. R.

AU - Van Veldhuisen, D. J.

AU - Kleber, F. X.

AU - Cowley, A. J.

AU - Ardia, A.

AU - Block, P.

AU - Cortina, A.

AU - Cserhalmi, L.

AU - Follath, F.

AU - Jensen, G.

AU - Kayanakis, J.

AU - Lie, K. I.

AU - Mancia, G.

AU - Skene, A. M.

PY - 1997/4/5

Y1 - 1997/4/5

N2 - Background: Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. We assessed the effect of ibopamine on survival in patients with advanced heart failure in a multicentre, randomised placebo-controlled study. Methods: Patients with advanced severe heart failure (New York Heart Association classes III and IV) and evidence of severe left-ventricular disease, who were already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The primary endpoint was all-cause mortality. The study was designed to recruit 2200 patients, and the minimum duration of treatment would be 6 months. We did intention-to-treat and on-treatment analyses; a post-hoc subgroup analysis was also done. Findings: After we had recruited 1906 patients the trial was stopped early, because of an excess of deaths among patients in the ibopamine group. 232 (25%) of 953 patients in the ibopamine group died, compared with 193 (20%) of 953 patients in the placebo group (relative risk 1-26 [95% CI 1.04-1.53], p = 0.017). The average length of follow-up was 347 days in the ibopamine group and 363 days in the placebo group. In multivariate analysis, only the use of antiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients. Interpretation: Ibopamine seems to increase the risk of death among patients with advanced heart failure who are already receiving optimum therapy, but the reasons for this increase are not clear. Our finding that antiarrhythmic treatment was a significant predictor of increased mortality in ibopamine-treated patients may be important, but exploratory analyses must be interpreted with caution.

AB - Background: Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. We assessed the effect of ibopamine on survival in patients with advanced heart failure in a multicentre, randomised placebo-controlled study. Methods: Patients with advanced severe heart failure (New York Heart Association classes III and IV) and evidence of severe left-ventricular disease, who were already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The primary endpoint was all-cause mortality. The study was designed to recruit 2200 patients, and the minimum duration of treatment would be 6 months. We did intention-to-treat and on-treatment analyses; a post-hoc subgroup analysis was also done. Findings: After we had recruited 1906 patients the trial was stopped early, because of an excess of deaths among patients in the ibopamine group. 232 (25%) of 953 patients in the ibopamine group died, compared with 193 (20%) of 953 patients in the placebo group (relative risk 1-26 [95% CI 1.04-1.53], p = 0.017). The average length of follow-up was 347 days in the ibopamine group and 363 days in the placebo group. In multivariate analysis, only the use of antiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients. Interpretation: Ibopamine seems to increase the risk of death among patients with advanced heart failure who are already receiving optimum therapy, but the reasons for this increase are not clear. Our finding that antiarrhythmic treatment was a significant predictor of increased mortality in ibopamine-treated patients may be important, but exploratory analyses must be interpreted with caution.

UR - http://www.scopus.com/inward/record.url?scp=8244241095&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=8244241095&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(96)10488-8

DO - 10.1016/S0140-6736(96)10488-8

M3 - Article

VL - 349

SP - 971

EP - 977

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9057

ER -