Quantitative assessment of baseline imbalances in evolocumab and alirocumab trials: a meta-epidemiological study.

ABSTRACT:

Background

Baseline imbalances have been identified in randomized trials of evolocumab and alirocumab. Our aim was to quantitatively assess (1) the presence of systematic baseline differences, and (2) the relationship of baseline differences with effects on low-density lipoprotein-cholesterol (LDL-c) and clinical outcomes in the trials.

Methods

We performed a meta-epidemiological study. PubMed, Embase, regulatory reports, ClinicalTrials.gov and company websites were searched for trials. Seven baseline characteristics (mean age, LDL-c, BMI, percentage males, diabetics, smokers, and hypertensives) and five outcomes (LDL-c, major adverse cardiac events, serious adverse events, any adverse events, all-cause mortality) were extracted. We calculated (1) range and distribution of b

SUBMITTER: van Bruggen FH 

PROVIDER: S-EPMC11193208 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature