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.