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Cardiac magnetic resonance biomarkers as surrogate endpoints in cardiovascular trials for myocardial diseases

European Heart Journal, ehad510, https://doi.org/10.1093/eurheartj/ehad510
Published: 13 September 2023

2nd citation of paper is to M. Budoff et al.’s EVAPORATE study:

Imaging surrogate endpoints for clinical trials

Evidence-based assessments of novel therapeutics depend on properly conducted randomized outcome trials. The accumulation of clinical endpoints over time defines the efficacy and safety of new treatments and informs guideline committees and regulatory agencies. However, conducting large clinical trials is costly and time-consuming. These practical factors stimulated the search for alternate or complementary imaging endpoints that may be implemented in clinical trials with several potential merits. First, an imaging endpoint may guide clinical trials by improving disease diagnosis or optimizing risk stratification [e.g. implantation of an implantable cardioverter defibrillator (ICD) in ischaemic cardiomyopathy might be guided by the extent of late gadolinium enhancement (LGE) in cardiac magnetic resonance (CMR)].1 Second, an imaging endpoint may serve as a surrogate marker of treatment efficacy [e.g. the effect of icosapent ethyl on low-attenuation plaque volume in coronary computed tomography angiography(CCTA) in patients with hypertriglyceridaemia].2

2. Budoff MJ, Bhatt DL, Kinninger A, Lakshmanan S, Muhlestein JB, Le VT, et al. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial. Eur Heart J 2020;41:3925–32. https://doi.org/10.1093/eurheartj/ehaa652