In a study from the University of Oxford, scientists found new evidence that treatment with the novel anti-osteoporotic medicine, romosozumab, may lead to a higher heart disease risk.
They found that by combining data across clinical trials of romosozumab, there is some evidence that the use of this drug leads to an increased heart attack risk.
Previous clinical trials of romosozumab have suggested that participants taking this medicine may be at higher risk of developing serious cardiovascular complications such as heart attacks or strokes.
This finding was not consistently seen across all trials of romosozumab, which limited conclusions about the safety of this medicine.
In 2019, the U.S. Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) approved romosozumab for use in postmenopausal women with osteoporosis, with both agencies issuing warning labels related to the potential risk of cardiovascular complications.
In the study, the team analyzed data from clinical trials and large-scale human genetic datasets to assess the evidence for this potential risk, including more than 50,000 people who had experienced a fracture and more than 100,000 people who had a stroke or heart attack.
They also analyzed genetic data in more than one million people and found that people whose DNA carried genetic markers that mimic the effect of romosozumab, a sclerostin blocker, had, on average, a 41% lower risk of sustaining a fracture but an 18% increased risk of a heart attack.
This supports the increased risk of heart attacks seen in the trials of romosozumab.
The findings support the warning labels issued by regulatory authorities such as the FDA and EMA and suggest that the heart disease effects seen in some trials of this medicine are real.
This emphasizes the importance of conducting further rigorous clinical studies to evaluate the cardiovascular safety of this class of medicines.
The team says this new medicine is effective at lowering the risk of fracture, which can be life-threatening, particularly for the elderly.
Patients and their healthcare providers should jointly consider whether the benefits of fracture prevention outweigh the potential risk of heart disease.
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The study was published in Science Translational Medicine and conducted by Dr. Jonas Bovijn et al.
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