Association between use of romosozumab and cardiovascular events: analysis of the Japanese Adverse Event Report database

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.