Optimization of the MACE endpoint composition to increase power in studies of lipid-lowering therapies-a model-based meta-analysis.

ABSTRACT:

Aims

To develop a model-informed methodology for the optimization of the Major Adverse Cardiac Events (MACE) composite endpoint, based on a model-based meta-analysis across anti-hypercholesterolemia trials of statin and anti-PCSK9 drugs.

Methods and results

Mixed-effects meta-regression modeling of stand-alone MACE outcomes was performed, with therapy type, population demographics, baseline and change over time in lipid biomarkers as predictors. Randomized clinical trials up to June 28, 2022, of either statins or anti-PCSK9 therapies were identified through a systematic review process in PubMed and ClinicalTrials.gov databases. In total, 54 studies (270,471 patients) were collected, reporting 15 different single cardiovascular events. Treatment-mediated decrease in low densi

SUBMITTER: Volkova A 

PROVIDER: S-EPMC10832431 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature