| Autor: |
Lenihan DJ; Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee., Anderson SA; Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee., Lenneman CG; Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee., Brittain E; Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee., Muldowney JAS 3rd; Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee., Mendes L; Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee., Zhao PZ; Acorda Therapeutics, Inc., Ardsley, New York., Iaci J; Acorda Therapeutics, Inc., Ardsley, New York., Frohwein S; Emory Heart and Vascular Center at Emory Saint Joseph's, Atlanta, Georgia., Zolty R; University of Nebraska Medical Center, Omaha, Nebraska., Eisen A; Acorda Therapeutics, Inc., Ardsley, New York., Sawyer DB; Maine Medical Center, Portland, Maine., Caggiano AO; Acorda Therapeutics, Inc., Ardsley, New York. |
| Abstrakt: |
A first-in-human, phase 1, double blind, placebo-controlled, single ascending dose study examined the safety, tolerability, and exploratory efficacy of intravenous infusion of a recombinant growth factor, cimaglermin alfa, in patients with heart failure and left ventricular systolic dysfunction (LVSD). In these patients on optimal guideline-directed medical therapy, cimaglermin treatment was generally tolerated except for transient nausea and headache and a dose-limiting toxicity was noted at the highest planned dose. There was a dose-dependent improvement in left ventricular ejection fraction lasting 90 days following infusion. Thus, cimaglermin is a potential therapy to enhance cardiac function in LVSD and warrants further investigation. |
