To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Tolvaptan Combo Therapy Provides Significant Advantage Over Therapy Alone in Treating Acute Heart Failure Syndromes: Presented at HF2008 URL: http://www.pslgroup.com/dg/223922.htm Doctor's Guide June 15, 2008
By Chris Berrie MILAN, Italy -- June 15, 2008 -- Tolvaptan plus standard therapy significantly improves signs and symptoms over standard therapy alone for patients hospitalised with acute heart failure syndromes (AHFS), as assessed by their treating physicians and reported here on June 15 at the Heart Failure 2008 Congress. This retrospective analysis was a tertiary endpoint from the randomised Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) trials and was presented on behalf of the EVEREST investigators by Peter S. Pang, MD, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. The main inclusion criteria for the 4,133 patients in the EVEREST trials with AHFS who were admitted to hospital and randomised were worsening heart failure and ejection fraction <40%. The physicians' assessments were based on 4-point scales for dyspnea, orthopnea, and fatigue (none, to continuous), for rales (none, to bases, to >50% way up), and for jugular venous distension (JVD; <6, 6-9, 10-15, and >15 cm), with a 5-point scale for pedal oedema (absent, to marked). Prior to randomisation, the patient group showed 60% New York Heart Association (NYHA) class 3 and 40% class 4; 91% had frequent or continuous dyspnea; 79% had pedal oedema >=1+; 54% had frequent or continuous orthopnea; 81% had rales; and 85% had frequent or continuous fatigue. Dr. Pang said, "The larger [EVEREST] study showed decreases in body weight, but one of the things we wanted to show was kind of more of a clinical picture, for the practising physician." Thus, patients in the tolvaptan group showed significantly greater reductions in body weight compared with those on placebo (P < .05), indicative of greater decrease in fluid overload. Over 7 days of assessment during hospitalisation, patients showed significant improvement with tolvaptan over placebo for oedema (day 1, 57.6% vs 52.6%; day 3, 83.8% vs 81.4%; day 7, 91.5% vs 91.0%; all P < .05). Similarly, over the first 4 days, dyspnea showed significant benefits for tolvaptan over placebo (day 1, 51.6% vs 47.1%; day 4, 79.7% vs 78.5%; all P < .05), as did orthopnea and JVD over the first 3 days (respectively, day 1, 63.1% vs 59.2% and 48.6% vs 43.8%; day 3, 83.4% vs 80.4% and 71.0% vs 65.6%; all P < .05). Fatigue showed a beneficial trend with tolvaptan over placebo during the first 2 days, which reached significance from day 3 (64.3% vs 60.2%; P < .05) to day 6 (74.0% vs 71.3%; P < .05). Dr. Pang also noted that for the safety analysis, the tolvaptan group showed no excess changes in hypotension, tachycardia, renal failure, serum potassium and magnesium, and liver function. Thus, while in the main trial there was no difference between the treatments for mortality and essentially none for renal function, he added, "I think that what it shows here is that at least from the physicians' perspective, you definitely get an improvement in the most common signs and symptoms for patients who suffer heart failure." This study was sponsored by Otsuka. [Study title: Effects of Tolvaptan on Physician-Assessed Signs and Symptoms in Patients Hospitalised With Acute Heart Failure – Results From the EVEREST Programme. Poster Session 2. Abstract P267.] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.