Reduced cardiovascular risks in osteoporosis patients treated with FDA-approved romosozumab
A real-world data study led by pharmacoepidemiologist Jay Lin (Amgen, CA, USA) found that post-menopausal women taking romosozumab – marketed as Evenity – for osteoporosis did not experience a heightened risk of cardiovascular complications, such as stroke or myocardial infarction (MI).
Originally, the FDA approved romosozumab as a monthly injection for those with post-menopausal osteoporosis with a high risk of bone fracture in April 2019.
The packaging warned of an increased chance of cardiovascular complications and deaths, therefore patients who had suffered cardiovascular issues in the past year were advised against taking it.
The findings of this study, presented at the American College of Rheumatology (ACR) 2021 conference, showed that the prevalence of cardiovascular complications could have reduced as a result of the warning label.
By providing this warning, the selection of patients suitable to receive romosozumab was strict and resulted in a “low proportion of patients who had a MI/stroke within 1 year prior to treatment initiation” as stated by Lin and colleagues. This is despite many osteoporosis patients having “more comorbidities including cardiovascular risk factors.”
In order to understand this association, real-world evidence was utilized. Lin and his team studied insurance claims, alongside electronic health record data collected between April 2019 to March 2020.
Using real-world data, this safety assessment discovered that approximately 15,000 people exposed to romosozumab had been reported in the USA. Therefore, this study demonstrated that the risk of cardiovascular complications was not linked to an increase, potentially due to the FDA label warning.
The retrospective study utilized the real-world data to conduct four pairwise comparisons. The clinical history of patients could easily be compared with romosozumab treatment as a result.
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The researchers included females under 55 years old in this assessment. Participants were either on romosozumab, parathyroid hormone (PTH) analogues, zolendronate, denosumab or oral bisphosphonates. Clinical history of up to 19 years was noted, including cardiovascular history, comorbidities and concomitant medications.
Scientists found that patients starting romosozumab were older than those on PTH analogues, zolendronate and oral bisphosphates; patients also experienced a higher prevalence of chronic diseases such as Type 2 diabetes, hyperlipidaemia and hypertension.
Patients on regular therapy were more likely to use health care services, report any osteoporosis treatment and any prior fractures.
While patients on romosozumab were more likely to have a history of MI or stroke compared with those on alternative treatments, the incidence of MI or stroke in the year prior to romosozumab therapy was low.
Researchers of this study concluded that the FDA’s regulation had lessened the prevalence of cardiovascular complications by ensuring careful patient selection.