A new article was published in Frontiers in Cardiovascular Medicine

Alina Volkova, Boris Shulgin, Gabriel Helmlinger, Kirill Peskov, Victor Sokolov. Optimization of the MACE endpoint composition to increase power in studies of lipid-lowering therapies—a model-based meta-analysis. Front. Cardiovasc. Med., Sec. Cardiovascular Epidemiology and Prevention.

A model-informed methodology was developed to optimize the Major Adverse Cardiac Events (MACE) composite endpoint by analyzing data from anti-hypercholesterolemia trials of statin and anti-PCSK9 drugs. Mixed-effects meta-regression modeling identified significant predictors for MACE outcomes, including lipid biomarkers, population demographics, and therapy type. This approach allowed for the calculation of required sample sizes for achieving statistical significance in relative risk reduction, providing a tool to optimize trial design in dyslipidemia and other therapeutic areas.