Cardiovascular Risk of Romosozumab vs. Teriparatide: A Cohort Study Using Japan's National Claims Database

Area of Science:

• Cardiovascular Science
• Pharmacology
• Real-world Evidence

Background:

• Previous analyses indicated a potential cardiovascular risk signal for romosozumab.
• Real-world studies had not found statistically significant associations, necessitating further investigation.

Purpose of the Study:

• To compare the cardiovascular risks of romosozumab versus teriparatide.
• To evaluate risks in the general population and in patients with a history of major adverse cardiovascular events (MACE).

Main Methods:

• A new user cohort study utilized Japan's national claims database.
• Included patients aged ≥40 years initiating romosozumab or teriparatide (March 2019-March 2023).
• Multivariable Cox proportional hazards models assessed MACE risk, with subgroup analyses based on MACE history.

Main Results:

• Analyzed 251,219 romosozumab users and 500,445 teriparatide users.
• Overall MACE incidence rates were 1.09 (romosozumab) and 1.22 (teriparatide) per 100 person-years.
• The adjusted hazard ratio for MACE was 1.00 (0.94-1.06) for romosozumab vs. teriparatide, with no significant differences in subgroups based on MACE history.

Conclusions:

• No statistically significant difference in MACE risk was observed between romosozumab and teriparatide.
• This finding held true regardless of a patient's prior history of major adverse cardiovascular events.
• The study provides real-world evidence on the comparative cardiovascular safety of these osteoporosis treatments.