Association between use of romosozumab and cardiovascular events:
analysis of the Japanese Adverse Event Report database
Abstract
There is concern about an increased risk of cardiovascular events in
romosozumab users. This study evaluated the association between use of
romosozumab and cardiovascular events using the Japanese Adverse Drug
Event Report database. In total, 868 romosozumab users were identified.
Disproportionality of cardiac events (reporting odds ratio [ROR]:
11.5, 95% confidence interval [CI]: 8.58–15.2; P < 0.01)
and cerebrovascular events (ROR: 7.03, 95% CI: 5.46–8.93; P
< 0.01) was observed. Cardiac events were significantly
increased in patients with cardiac disease (odds ratio [OR]: 2.74,
95% CI: 1.37–5.49; P < 0.01), hypertension (OR: 1.97, 95%
CI: 1.07–3.63; P = 0.03), and diabetes (OR: 2.36, 95% CI: 1.16–4.80;
P = 0.02). Similar results were found regarding the risk factors for
cerebrovascular events. This study suggests that comorbidities such as
hypertension and diabetes may increase the risk of cardiovascular events
in romosozumab users.