✍ Scribed by Frank G. Shellock; John R. Parker; Gianpaolo Pirovano; Ningyan Shen; Carol Venetianer; Miles A. Kirchin; Alberto Spinazzi
No coin nor oath required. For personal study only.
To evaluate the safety and tolerability of gadobenate dimeglumine (Gd‐BOPTA) relative to that of gadopentetate dimeglumine (Gd‐DTPA) in patients and volunteers undergoing MRI for various clinical conditions.
A total of 924 subjects were enrolled in 10 clinical trials in which Gd‐BOPTA was compared with Gd‐DTPA. Of these subjects, 893 were patients with known or suspected disease and 31 were healthy adult volunteers. Of the 893 patients, 174 were pediatric subjects (aged two days to 17 years) referred for MRI of the brain or spine. Safety evaluations included monitoring vital signs, laboratory values, and adverse events (AE).
The rate of AE in adults was similar between the two agents (Gd‐BOPTA: 51/561, 9.1%; Gd‐DTPA: 33/472, 7.0%; P = 0.22). In parallel‐group studies in which subjects were randomized to either agent, the rate of AE was 10.9% for Gd‐BOPTA and 7.9% for Gd‐DTPA (P = 0.21). In the subset of subjects receiving both agents in intraindividual crossover trials, the rate of AE was 8.0% for Gd‐BOPTA and 8.5% for Gd‐DTPA (P = 0.84). Results of other safety assessments (laboratory tests, vital signs) were similar for the two agents.
The safety profile of Gd‐BOPTA is similar to Gd‐DTPA in patients and volunteers. Both compounds are equally well‐tolerated in patients with various disease states undergoing MRI. J. Magn. Reson. Imaging 2006. © 2006 Wiley‐Liss, Inc.
📜 SIMILAR VOLUMES
Clinical trials completed by September 2000 on gadobenate dimeglumine (Gd-BOPTA; MultiHance) included 2540 adult and pediatric subjects that were administered this agent. For adult patient volunteers, the overall incidence of adverse events (AEs) was 19.8%, although marked study- and indication-rela