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Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study.

Abstract

STUDY OBJECTIVES

To examine the effects of long-term intermittent dobutamine infusion, combined with oral amiodarone in patients with congestive heart failure (CHF) refractory to standard medical treatment.

DESIGN

Prospective, randomized, double-blind, placebo-controlled clinical trial.

SETTING

Inpatient and outpatient heart failure clinic in a university teaching hospital.

PATIENTS AND INTERVENTIONS

Thirty patients with end-stage CHF refractory to standard medical treatment who could be weaned from dobutamine therapy after a first 72-h infusion were randomized in a double-blind manner to receive IV infusions of placebo (group 1; 14 patients) vs dobutamine in a dose of 10 micro g/kg/min (group 2; 16 patients) for 8 h every 14 days. All patients received standard medical therapy and also were treated with oral amiodarone, 400 mg/d, which was started at least 2 weeks before randomization.

MEASUREMENTS AND RESULTS

Kaplan-Meier survival analysis showed a 60% reduction in the risk of death from any cause in the group treated with the combination of dobutamine and amiodarone, compared with the group treated with placebo and amiodarone (hazard ratio, 0.403; 95% confidence interval, 0.164 to 0.992; p = 0.048). The 1-year and 2-year survival rates were 69% and 44%, respectively, in the dobutamine-treated group, vs 28% and 21%, respectively, in the placebo-treated group (p < 0.05 for both comparisons). Median survival times were 574 and 144 days, respectively, for groups 2 and 1. At 6 months, the New York Heart Association functional class was significantly improved in the patients who survived from both groups.

CONCLUSIONS

Long-term intermittent dobutamine infusion combined with amiodarone added to the conventional drugs improved the survival of patients with advanced CHF that was refractory to conventional treatment.

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  • Authors+Show Affiliations

    ,

    University of Athens School of Medicine, Department of Clinical Therapeutics, Alexandra Hospital, Athens, Greece. jnanas@ath.forthnet.gr

    , , , , ,

    Source

    Chest 125:4 2004 Apr pg 1198-204

    MeSH

    Administration, Oral
    Amiodarone
    Cardiotonic Agents
    Dobutamine
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Heart Failure
    Humans
    Infusions, Intravenous
    Male
    Middle Aged
    Prospective Studies
    Survival Rate
    Vasodilator Agents

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    15078725

    Citation

    Nanas, John N., et al. "Long-term Intermittent Dobutamine Infusion, Combined With Oral Amiodarone for End-stage Heart Failure: a Randomized Double-blind Study." Chest, vol. 125, no. 4, 2004, pp. 1198-204.
    Nanas JN, Tsagalou EP, Kanakakis J, et al. Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study. Chest. 2004;125(4):1198-204.
    Nanas, J. N., Tsagalou, E. P., Kanakakis, J., Nanas, S. N., Terrovitis, J. V., Moon, T., & Anastasiou-Nana, M. I. (2004). Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study. Chest, 125(4), pp. 1198-204.
    Nanas JN, et al. Long-term Intermittent Dobutamine Infusion, Combined With Oral Amiodarone for End-stage Heart Failure: a Randomized Double-blind Study. Chest. 2004;125(4):1198-204. PubMed PMID: 15078725.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study. AU - Nanas,John N, AU - Tsagalou,Eleftheria P, AU - Kanakakis,John, AU - Nanas,Serafim N, AU - Terrovitis,John V, AU - Moon,Thomas, AU - Anastasiou-Nana,Maria I, PY - 2004/4/14/pubmed PY - 2004/5/18/medline PY - 2004/4/14/entrez SP - 1198 EP - 204 JF - Chest JO - Chest VL - 125 IS - 4 N2 - STUDY OBJECTIVES: To examine the effects of long-term intermittent dobutamine infusion, combined with oral amiodarone in patients with congestive heart failure (CHF) refractory to standard medical treatment. DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. SETTING: Inpatient and outpatient heart failure clinic in a university teaching hospital. PATIENTS AND INTERVENTIONS: Thirty patients with end-stage CHF refractory to standard medical treatment who could be weaned from dobutamine therapy after a first 72-h infusion were randomized in a double-blind manner to receive IV infusions of placebo (group 1; 14 patients) vs dobutamine in a dose of 10 micro g/kg/min (group 2; 16 patients) for 8 h every 14 days. All patients received standard medical therapy and also were treated with oral amiodarone, 400 mg/d, which was started at least 2 weeks before randomization. MEASUREMENTS AND RESULTS: Kaplan-Meier survival analysis showed a 60% reduction in the risk of death from any cause in the group treated with the combination of dobutamine and amiodarone, compared with the group treated with placebo and amiodarone (hazard ratio, 0.403; 95% confidence interval, 0.164 to 0.992; p = 0.048). The 1-year and 2-year survival rates were 69% and 44%, respectively, in the dobutamine-treated group, vs 28% and 21%, respectively, in the placebo-treated group (p < 0.05 for both comparisons). Median survival times were 574 and 144 days, respectively, for groups 2 and 1. At 6 months, the New York Heart Association functional class was significantly improved in the patients who survived from both groups. CONCLUSIONS: Long-term intermittent dobutamine infusion combined with amiodarone added to the conventional drugs improved the survival of patients with advanced CHF that was refractory to conventional treatment. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/15078725/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)32076-6 DB - PRIME DP - Unbound Medicine ER -