Cardiovascular Outcomes of Romosozumab Treatment – Real World Data Analysis

Abstract

Abstract Romosuzumab is a potent treatment for osteoporosis, with significant effects on bone density and fracture prevention. This study evaluated the cardiovascular safety of romosozumab in a real-world cohort of postmenopausal women at high fracture-risk. We retrospectively evaluated postmenopausal women who initiated treatment with romosuzumab between January 1, 2020, and June 30, 2023. We examined the occurrence of a Major Adverse Cardiovascular-Event (MACE) during and after treatment. After applying inclusion and exclusion criteria, 847 women were followed for a median of 729 days (interquartile range [IQR]: 445-1060). The incidence rate of MACE was 24.0 (95%CI 17.7-32.5) per 1000 person-years during the study period. The change in the rate of MACE from 0-90 days and 90-365 days post-treatment initiation was 0.04 and 0.06 events per 1000 days, respectively. The difference in the rate between these intervals was not statistically significant (P=.09). After 1 year of treatment, the slope of MACE increased to 0.10, differing significantly from the preceding 12 months on treatment (P<.001). The incidence of MACE was higher in those with a background of previous cardiovascular disease or diabetes at all timepoints, as expected. The consistency in event rates during treatment suggests that romosozumab is not associated with an increase in MACE in postmenopausal women. This finding challenges reports suggesting an increase in cardiovascular events within the first year of romosuzumab treatment.