Bayer’s Gadovist™ (Gadobutrol) at a Reduced Dose Demonstrates Non-Inferiority Compared to a Standard Dose of Gadoterate for CNS Imaging

Phase IV LEADER-75 study showed 25 percent reduction in standard dose of gadobutrol is non-inferior to gadoterate full dose in improvement of visualization imaging parameters / Diagnostic equivalence of the two contrast regimens was confirmed by a post hoc analysis

Bayer published today the results of its LEADER-75 (LowEr Administered Dose with highEr Relaxivity) study, demonstrating the clinical efficacy of a reduced dose of gadobutrol compared to a typical dose of gadoterate in patients undergoing a steady-state contrast-enhanced MRI of the CNS. The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 mmol/kg) for CNS imaging. the entire number of lesions detected by mean reading was 301 for gadobutrol versus 291 for gadoterate. The study data was presented at this year’s hybrid annual meeting of the ecu Society for Neuroradiology (ESNR), happening in Geneva, Switzerland, from Michaelmas to October 3, 2021.

“The LEADER-75 study showed that a reduced dose of Gadovist™, given its high relaxivity, may achieve essentially equivalent diagnostic efficacy as a typical gadoterate dose in CNS imaging,” said Dr. Benjamin P. Liu, Division of Neuroradiology, Northwestern Memorial Hospital, Chicago, Illinois, USA, and therefore the LEADER-75 coordinating investigator.

Gadobutrol is an approved and commonly used macrocyclic gadolinium-based contrast agent (GBCA) for CNS imaging and a number of other other indications. MRI provides a radiation-free, non-invasive means to get detailed images of the body. The administration of GBCAs during MRI helps physicians answer critical medical questions within the diagnosis and monitoring of disease. Currently, the quality dose for all marketed GBCAs, including gadobutrol and gadoterate, is 0.1 mmol/kg weight .

“At Bayer, we are constantly striving to supply the simplest possible therapeutic and diagnostic options for physicians and patients,” said Prof. Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. “LEADER-75 underlines our commitment to developing contrast agents that provide physicians with the image enhancement required for optimal diagnosis while continuing to explore opportunities to scale back the dose for patients as best as possible.”

About LEADER-75
The LEADER-75 study analysis included 141 male and feminine adult patients a minimum of 18 years aged , of any ethnos with known or highly suspected contrast enhancing CNS pathologies. All patients were referred for contrast-enhanced MRI of the CNS supported current clinical symptoms or on a previous imaging procedure. the first objective of the study was to demonstrate the non-inferiority of a reduced dose of gadobutrol compared to a typical dose of gadoterate supported blinded readers’ evaluation of three primary variables: degree of lesion contrast enhancement, assessment of lesion border delineation, and internal morphology of lesions. during a post-hoc analysis, mean reading for these three primary variables differed by but 1% between gadobutrol and gadoterate, supporting equivalence of all measures employing a narrow ±5% margin (p≤ .025). Safety was evaluated by analyzing the frequency of treatment-emergent adverse events (TEAE). there have been five patients (3.2%) with TEAEs, which were non-serious and mild. there have been three patients (1.9%) with drug-related TEAEs – one on gadobutrol (paresthesia) and two on gadoterate (pruritus, urticaria).

About Gadovist™ (gadobutrol)
Gadobutrol was first approved for contrast enhanced (CE) MRI of the central systema nervosum (CNS) in 1998 and is currently approved for several indications in additional than 100 countries, including the ecu Union (EU), Australia, Canada, China, South Africa , Mexico, New Zealand, Turkey, Japan, and a number of other Asian countries. Approved indications include CE MRI of the CNS, CE-MRA (2003), CE MRI of the liver and kidneys (2007), and CE MRI of all body regions (whole body, 2012) within the EU and other countries.

Gadobutrol injection was first approved within the U.S. in March 2011 for intravenous use in diagnostic resonance imaging in adults and youngsters (2 years aged and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central systema nervosum . it had been further approved within the U.S. in 2014 for MRI of the breast to assess the presence and extent of malignant breast disease and for pediatric patients but 2 years aged , including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central systema nervosum . In 2016, it had been approved within the U.S.

About Radiology at Bayer
Everyone deserves clear answers about their health, starting with an early and accurate diagnosis. As a real life-science company with a heritage of around 100 years in Radiology, Bayer is committed to providing excellence, from innovative products to high-quality services. The portfolio includes contrast media for computerized tomography (CT), X-Ray, and resonance imaging (MRI), devices for his or her precise administration, informatics solutions to support efficient and optimal patient care, also as acknowledged educational programs. additionally , Bayer is strongly committed to research and development and leverages AI , thus further driving innovation in medical imaging. Each of those offerings helps radiologists in their mission to deliver answers and a transparent direction – from diagnosis to worry .

About Bayer
Bayer may be a global enterprise with core competencies within the bioscience fields of health care and nutrition. Its products and services are designed to assist people and planet thrive by supporting efforts to master the main challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At an equivalent time, the Group aims to extend its earning power and make value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the planet . In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros.

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