Effects of tolvaptan on physician-assessed symptoms and signs in patients hospitalized with acute heart failure syndromes

Analysis from the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) Trials

Peter Pang, Mihai Gheorghiade, Jamil Dihu, Karl Swedberg, Sadiya Khan, Aldo P. Maggioni, Liliana Grinfeld, Faiez Zannad, John C. Burnett, John Ouyang, James E. Udelson, Marvin A. Konstam

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Background: A rapid and sustained relief of heart failure (HF) symptoms and signs is an important goal of management in patients hospitalized for acute HF syndromes (AHFS). To date, no novel therapy in AHFS have been shown to improve signs and symptoms throughout hospitalization. This study explores the clinical effects of tolvaptan, a vasopressin-2-receptor antagonist, in addition to standard medical therapies on physician-assessed signs and symptoms in hospitalized AHFS patients. Methods: The EVEREST trial randomized 4,133 patients admitted with worsening HF and reduced ejection fraction (≤40%) within 48 hours after hospital admission. On each inpatient day, investigators assessed dyspnea, orthopnea, fatigue, jugular venous distension (JVD), rales, and pedal edema by predefined ordinal scales. Responder analyses were performed for each sign and symptom, with significant clinical response defined as a change in one point on the measurement scale. Results: Post hoc analysis demonstrated greater likelihood of clinical improvement in physician-assessed dyspnea, edema, orthopnea, and JVD among tolvaptan-treated subjects (P <.05) as early as inpatient day 1. This difference was observed throughout hospitalization only for JVD and orthopnea through day 3. Conclusion: The addition of tolvaptan to standard therapy for AHFS improves physician-assessed signs and symptoms during hospitalization without serious adverse short- or long-term effects.

Original languageEnglish (US)
Pages (from-to)1067-1072
Number of pages6
JournalAmerican Heart Journal
Volume161
Issue number6
DOIs
StatePublished - Jun 2011
Externally publishedYes

Fingerprint

Vasopressins
Signs and Symptoms
Heart Failure
Outcome Assessment (Health Care)
Physicians
Hospitalization
Neck
Dyspnea
Inpatients
Edema
Respiratory Sounds
Fatigue
Foot
Therapeutics
Research Personnel
tolvaptan

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Effects of tolvaptan on physician-assessed symptoms and signs in patients hospitalized with acute heart failure syndromes : Analysis from the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) Trials. / Pang, Peter; Gheorghiade, Mihai; Dihu, Jamil; Swedberg, Karl; Khan, Sadiya; Maggioni, Aldo P.; Grinfeld, Liliana; Zannad, Faiez; Burnett, John C.; Ouyang, John; Udelson, James E.; Konstam, Marvin A.

In: American Heart Journal, Vol. 161, No. 6, 06.2011, p. 1067-1072.

Research output: Contribution to journalArticle

Pang, Peter ; Gheorghiade, Mihai ; Dihu, Jamil ; Swedberg, Karl ; Khan, Sadiya ; Maggioni, Aldo P. ; Grinfeld, Liliana ; Zannad, Faiez ; Burnett, John C. ; Ouyang, John ; Udelson, James E. ; Konstam, Marvin A. / Effects of tolvaptan on physician-assessed symptoms and signs in patients hospitalized with acute heart failure syndromes : Analysis from the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) Trials. In: American Heart Journal. 2011 ; Vol. 161, No. 6. pp. 1067-1072.
@article{099d7087874a45ffa9f1e8dac5b43b88,
title = "Effects of tolvaptan on physician-assessed symptoms and signs in patients hospitalized with acute heart failure syndromes: Analysis from the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) Trials",
abstract = "Background: A rapid and sustained relief of heart failure (HF) symptoms and signs is an important goal of management in patients hospitalized for acute HF syndromes (AHFS). To date, no novel therapy in AHFS have been shown to improve signs and symptoms throughout hospitalization. This study explores the clinical effects of tolvaptan, a vasopressin-2-receptor antagonist, in addition to standard medical therapies on physician-assessed signs and symptoms in hospitalized AHFS patients. Methods: The EVEREST trial randomized 4,133 patients admitted with worsening HF and reduced ejection fraction (≤40{\%}) within 48 hours after hospital admission. On each inpatient day, investigators assessed dyspnea, orthopnea, fatigue, jugular venous distension (JVD), rales, and pedal edema by predefined ordinal scales. Responder analyses were performed for each sign and symptom, with significant clinical response defined as a change in one point on the measurement scale. Results: Post hoc analysis demonstrated greater likelihood of clinical improvement in physician-assessed dyspnea, edema, orthopnea, and JVD among tolvaptan-treated subjects (P <.05) as early as inpatient day 1. This difference was observed throughout hospitalization only for JVD and orthopnea through day 3. Conclusion: The addition of tolvaptan to standard therapy for AHFS improves physician-assessed signs and symptoms during hospitalization without serious adverse short- or long-term effects.",
author = "Peter Pang and Mihai Gheorghiade and Jamil Dihu and Karl Swedberg and Sadiya Khan and Maggioni, {Aldo P.} and Liliana Grinfeld and Faiez Zannad and Burnett, {John C.} and John Ouyang and Udelson, {James E.} and Konstam, {Marvin A.}",
year = "2011",
month = "6",
doi = "10.1016/j.ahj.2011.02.027",
language = "English (US)",
volume = "161",
pages = "1067--1072",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "6",

}

TY - JOUR

T1 - Effects of tolvaptan on physician-assessed symptoms and signs in patients hospitalized with acute heart failure syndromes

T2 - Analysis from the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) Trials

AU - Pang, Peter

AU - Gheorghiade, Mihai

AU - Dihu, Jamil

AU - Swedberg, Karl

AU - Khan, Sadiya

AU - Maggioni, Aldo P.

AU - Grinfeld, Liliana

AU - Zannad, Faiez

AU - Burnett, John C.

AU - Ouyang, John

AU - Udelson, James E.

AU - Konstam, Marvin A.

PY - 2011/6

Y1 - 2011/6

N2 - Background: A rapid and sustained relief of heart failure (HF) symptoms and signs is an important goal of management in patients hospitalized for acute HF syndromes (AHFS). To date, no novel therapy in AHFS have been shown to improve signs and symptoms throughout hospitalization. This study explores the clinical effects of tolvaptan, a vasopressin-2-receptor antagonist, in addition to standard medical therapies on physician-assessed signs and symptoms in hospitalized AHFS patients. Methods: The EVEREST trial randomized 4,133 patients admitted with worsening HF and reduced ejection fraction (≤40%) within 48 hours after hospital admission. On each inpatient day, investigators assessed dyspnea, orthopnea, fatigue, jugular venous distension (JVD), rales, and pedal edema by predefined ordinal scales. Responder analyses were performed for each sign and symptom, with significant clinical response defined as a change in one point on the measurement scale. Results: Post hoc analysis demonstrated greater likelihood of clinical improvement in physician-assessed dyspnea, edema, orthopnea, and JVD among tolvaptan-treated subjects (P <.05) as early as inpatient day 1. This difference was observed throughout hospitalization only for JVD and orthopnea through day 3. Conclusion: The addition of tolvaptan to standard therapy for AHFS improves physician-assessed signs and symptoms during hospitalization without serious adverse short- or long-term effects.

AB - Background: A rapid and sustained relief of heart failure (HF) symptoms and signs is an important goal of management in patients hospitalized for acute HF syndromes (AHFS). To date, no novel therapy in AHFS have been shown to improve signs and symptoms throughout hospitalization. This study explores the clinical effects of tolvaptan, a vasopressin-2-receptor antagonist, in addition to standard medical therapies on physician-assessed signs and symptoms in hospitalized AHFS patients. Methods: The EVEREST trial randomized 4,133 patients admitted with worsening HF and reduced ejection fraction (≤40%) within 48 hours after hospital admission. On each inpatient day, investigators assessed dyspnea, orthopnea, fatigue, jugular venous distension (JVD), rales, and pedal edema by predefined ordinal scales. Responder analyses were performed for each sign and symptom, with significant clinical response defined as a change in one point on the measurement scale. Results: Post hoc analysis demonstrated greater likelihood of clinical improvement in physician-assessed dyspnea, edema, orthopnea, and JVD among tolvaptan-treated subjects (P <.05) as early as inpatient day 1. This difference was observed throughout hospitalization only for JVD and orthopnea through day 3. Conclusion: The addition of tolvaptan to standard therapy for AHFS improves physician-assessed signs and symptoms during hospitalization without serious adverse short- or long-term effects.

UR - http://www.scopus.com/inward/record.url?scp=79958149303&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79958149303&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2011.02.027

DO - 10.1016/j.ahj.2011.02.027

M3 - Article

VL - 161

SP - 1067

EP - 1072

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 6

ER -