Data from a new analysis is reinforcing the heightened concern surrounding the detrimental impact use of the novel osteoporotic therapy romosozumab can have on cardiovascular health. 



Results of the statistical analysis, which included data from a pair of phase 3 clinical trials and the UK Biobank cohort, concluded patients whose DNA carried genetic markers mimicking the effects of the novel sclerostin inhibitor had an 18% greater chance of suffering a heart attack.

“Our findings support the warning labels issued by regulatory authorities such as the FDA and EMA, and suggest that the cardiovascular effects seen in some trials of this medicine are real,” said lead investigator Jonas Bovjin, MBChB, MSc, of the Big Data Institute at the University of Oxford, in a statement. “This emphasizes the importance of conducting further rigorous clinical studies to evaluate the cardiovascular safety of this class of medicines.”

A collaborative effort between investigators from Oxford, University of Tartu, Broad Institute, Massachusetts General Hospital, and the University of Bristol, the current study was designed to assess the potential for cardiovascular complications associated with romosozumab using data from clinical trials and the UK Biobank cohort in 2 separate analyses.

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