دورية أكاديمية
Safety and tolerability of omecamtiv mecarbil during exercise in patients with ischemic cardiomyopathy and angina.
| العنوان: | Safety and tolerability of omecamtiv mecarbil during exercise in patients with ischemic cardiomyopathy and angina. |
|---|---|
| المؤلفون: | Greenberg BH; University of California at San Diego, San Diego, California. Electronic address: bgreenberg@ucsd.edu., Chou W; Cytokinetics, Inc., South San Francisco, California., Saikali KG; Cytokinetics, Inc., South San Francisco, California., Escandón R; Cytokinetics, Inc., South San Francisco, California., Lee JH; Cytokinetics, Inc., South San Francisco, California., Chen MM; Cytokinetics, Inc., South San Francisco, California., Treshkur T; Almazov Federal Heart Blood and Endocrinology Centre, St. Petersburg, Russia., Megreladze I; Cardiology Clinic, Tbilisi, Georgia., Wasserman SM; Amgen Inc., Thousand Oaks, California., Eisenberg P; Amgen Inc., Thousand Oaks, California., Malik FI; Cytokinetics, Inc., South San Francisco, California., Wolff AA; Cytokinetics, Inc., South San Francisco, California., Shaburishvili T; Diagnostic Services Clinic, Tbilisi, Georgia. |
| المصدر: | JACC. Heart failure [JACC Heart Fail] 2015 Jan; Vol. 3 (1), pp. 22-29. Date of Electronic Publication: 2014 Nov 11. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101598241 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-1787 (Electronic) Linking ISSN: 22131779 NLM ISO Abbreviation: JACC Heart Fail Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Elsevier, [2013]- |
| مواضيع طبية MeSH: | Drug Tolerance*, Angina Pectoris/*drug therapy , Exercise/*physiology , Myocardial Contraction/*drug effects , Myocardial Ischemia/*drug therapy , Urea/*analogs & derivatives, Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Angina Pectoris/diagnosis ; Angina Pectoris/physiopathology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Exercise Test ; Female ; Follow-Up Studies ; Georgia (Republic) ; Humans ; Male ; Middle Aged ; Myocardial Ischemia/diagnosis ; Myocardial Ischemia/physiopathology ; Retrospective Studies ; Russia ; Treatment Outcome ; Urea/administration & dosage |
| مستخلص: | Objectives: The goal of this study was to assess the safety and tolerability of omecamtiv mecarbil treatment during symptom-limited exercise in patients with ischemic cardiomyopathy and angina. These patients may have increased vulnerability to prolongation of the systolic ejection time. Background: Omecamtiv mecarbil is a selective cardiac myosin activator that augments cardiac contractility in patients with systolic heart failure through a dose-dependent increase in systolic ejection time. Methods: In this double-blind, placebo-controlled study, patients with chronic heart failure were randomized 2:1 to receive omecamtiv mecarbil or placebo in 2 sequential cohorts of escalating doses designed to achieve plasma concentrations previously shown to increase systolic function. Patients underwent 2 symptom-limited exercise treadmill tests (ETTs) at baseline (ETT1 and ETT2) and again before the end of a 20-h infusion of omecamtiv mecarbil (ETT3). Results: The primary pre-defined safety endpoint (i.e., the proportion of patients who stopped ETT3 because of angina at a stage earlier than baseline) was observed in 1 patient receiving placebo and none receiving omecamtiv mecarbil. No dose-dependent differences emerged in the proportion of patients stopping ETT3 for any reason or in the pattern of adverse events. Conclusions: Doses of omecamtiv mecarbil producing plasma concentrations previously shown to increase systolic function were well tolerated during exercise in these study patients with ischemic cardiomyopathy and angina. There was no indication that treatment increased the likelihood of myocardial ischemia in this high-risk population. (Pharmacokinetics [PK] and Tolerability of Intravenous [IV] and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina; NCT00682565). (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| التعليقات: | Erratum in: JACC Heart Fail. 2020 Aug;8(8):700. (PMID: 32731953) |
| فهرسة مساهمة: | Keywords: exercise tolerance; heart failure; ischemic cardiomyopathy; omecamtiv mecarbil |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00682565 |
| المشرفين على المادة: | 2M19539ERK (omecamtiv mecarbil) 8W8T17847W (Urea) |
| تواريخ الأحداث: | Date Created: 20141203 Date Completed: 20151006 Latest Revision: 20200706 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.jchf.2014.07.009 |
| PMID: | 25453536 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder كن أول من يترك تعليقا!