%0 Journal Article
%T Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, Single-Blind, Randomized Study in Chinese Patients
%A Zonghui Liang
%A Lin Ma
%A Dehang Wang
%A Yi Huan
%A Ping Li
%A Jun Yu
%A Zhenwei Yao
%A Shuang Chen
%A Huijin He
%A Xiaoyuan Feng and Josy Breuer
%J Magnetic Resonance Insights
%D 2012
%I 
%R 10.4137/MRI.S9348
%X The aim of this study was to compare the efficacy and safety of macrocyclic gadobutrol (1.0 M) with linear gadopentetate dimeglumine (0.5 M) for contrast-enhanced magnetic resonance imaging (MRI) of central nervous system (CNS) lesions in Chinese patients (N = 147) with known or suspected CNS lesions, who were enrolled in this single-blind, randomized, parallel-group study. Three blinded independent readers evaluated all efficacy variables. The primary efficacy variable was the difference between the two agents for the change in contrast-to-noise ratio (CNR) between non-enhanced and contrast-enhanced scans of lesions. Secondary outcomes included mean change in number of lesions detected before and after contrast enhancement, diagnostic confidence, and safety and tolerability parameters. Gadobutrol was non-inferior to gadopentetate dimeglumine in respect to the difference in the mean change in CNR (6.94; 95% confidence interval [CI] lower limit: -3.90; predefined maximum 95% CI lower limit: -6.52). The mean change in the number of CNS lesions detected was greater with gadobutrol versus gadopentetate dimeglumine (1.2 vs. 0.2 lesions). Diagnostic confidence was classified as ¡®high¡¯ for more patients with gadobutrol versus gadopentetate dimeglumine by the investigators (58.8% vs. 55.4%) and by the three blinded readers (63.6% vs. 55.7%, 23.7% vs. 18.0% and 81.7% vs. 81.0%). Both agents were well tolerated by participating patients. We concluded that in Chinese patients with CNS lesions, gadobutrol (1.0 M) was as effective and well tolerated in contrast-enhanced MRI as gadopentetate dimeglumine (0.5 M). Gadobutrol provided improved visualization of CNS lesions compared with gadopentetate dimeglumine, with a comparable tolerability profile.
%U http://www.la-press.com/efficacy-and-safety-of-gadobutrol-10-m-versus-gadopentetate-dimeglumin-article-a3357