Romosozumab and other sclerostin inhibitors may increase cardiovascular risk, suggests evidence from a meta-analysis of randomized trials and a study of genetic variants that mimic pharmacologic inhibition of sclerostin.

Romosozumab and other sclerostin inhibitors may increase cardiovascular risk, suggests evidence from a meta-analysis of randomized trials and a study of genetic variants that mimic pharmacologic inhibition of sclerostin.

The EMA notes that “serious cardiovascular events are an important identified risk” associated with romosozumab treatment.

medwireNews : The monoclonal antibody romosozumab has been approved in the USA for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

Results of the phase III ARCH trial suggest that women with osteoporosis who are treated with romosozumab are less likely to experience fractures, but may have an increased risk for cardiovascular events, compared with those given alendronate.

They point to zoledronic acid, which has been associated with an elevated risk for atrial fibrillation, and romosozumab, which was initially refused European approval due to an increased risk for major adverse cardiovascular events compared with alendronic acid, but recently received a positive opinion for severe postmenopausal osteoporosis  following a re-examination.

In an accompanying comment, Sundeep Khosla, from the Mayo Clinic College of Medicine in Rochester, Minnesota, USA, says: “DATA-HD is important because the increases in BMD and estimated bone strength using high dose teriparatide and denosumab seem to be greater across multiple skeletal sites than any single drug regimen (including the recently approved sclerostin antibody, romosozumab), or any previous combination treatment.”