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.
RCT Entities:
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.
Authors: Peter S Pang; Sean P Collins; Kori Sauser; Adin-Cristian Andrei; Alan B Storrow; Judd E Hollander; Miguel Tavares; Jindrich Spinar; Cezar Macarie; Dimitar Raev; Richard Nowak; Mihai Gheorghiade; Alexandre Mebazaa Journal: Acad Emerg Med Date: 2014-06 Impact factor: 3.451
Authors: M Manning; A Misicka; A Olma; K Bankowski; S Stoev; B Chini; T Durroux; B Mouillac; M Corbani; G Guillon Journal: J Neuroendocrinol Date: 2012-04 Impact factor: 3.627
Authors: Evi V Nagler; Maria C Haller; Wim Van Biesen; Raymond Vanholder; Jonathan C Craig; Angela C Webster Journal: Cochrane Database Syst Rev Date: 2018-06-28
Authors: Meaghan Lunney; Marinella Ruospo; Patrizia Natale; Robert R Quinn; Paul E Ronksley; Ioannis Konstantinidis; Suetonia C Palmer; Marcello Tonelli; Giovanni Fm Strippoli; Pietro Ravani Journal: Cochrane Database Syst Rev Date: 2020-02-27