Bayer is touting the findings of a pair of phase III clinical studies investigating its Gadavist (gadobutrol) MRI contrast agent for identifying coronary artery disease (CAD).
Researchers published the results of the phase III GadaCAD 1 and GadaCAD 2 clinical trials on September 21 in the Journal of the American College of Cardiology. The findings include data that support the ability of Gadavist to assess myocardial perfusion and late gadolinium enhancement in adults with CAD, according to Bayer.
The multinational, multicenter studies included approximately 1,000 adults with known or suspected CAD. Because of similar results, the authors summarized the findings in a fixed-effect meta-analysis, Bayer noted.
The authors concluded that vasodilator stress and rest myocardial perfusion cardiac MR and late gadolinium enhancement imaging had high diagnostic accuracy for CAD. They also noted the findings support the U.S. Food and Drug Administration's approval of Gadavist for contrast-enhanced cardiac MRI in July 2019.
