Introduction
Osteoporosis is a public health problem associated with risk fractures, and this risk has been increasing with aging.1Approximately 50% of women and 20% of men over the age of 50 years sustain an osteoporotic fracture, which can lead to long-term pain and disability,2 and even to death.1Hence, drug therapy for osteoporosis is important to improve quality of life and prognosis.
Romosozumab is approved for use in patients with moderate to severe osteoporosis. This drug has the dual effect to stimulate bone formation and inhibit bone resorption by inhibiting sclerostin, an osteocyte protein.3 Because of its dual effect, the risk of clinical fracture has been found to be 27% lower in patients on romosozumab than in those on oral alendronate.4However, romosozumab may increase the risk of cardiovascular events. A randomized controlled trial demonstrated that serious cardiovascular events occurred more frequently in romosozumab users (2.5%) than in alendronate users (1.9%).4 However, bisphosphonates can reduce arterial wall calcification,5 and have been associated with decreased risk of cardiovascular events compared with placebo.6 Therefore, it is unclear whether romosozumab itself increase the risk of cardiovascular events. Identification of risk factors for cardiovascular events may be useful to avoid adverse events with romosozumab and provide appropriate osteoporosis treatments. Herein, we evaluated the association between use of romosozumab and cardiovascular events using the Japanese Adverse Drug Event Report (JADER) database.