Although the overall study results provide no evidence of increased cardiovascular risk, these overall estimates are derived from the study population, in which most patients had short-term LDX exposure. In an analysis of long-term LDX use, there was a higher estimated risk of MACE among LDX users compared to what was observed in the overall study population. The emphasis on an elevated relative MACE risk above a predetermined threshold of 3.00 to be clinically relevant is not entirely appropriate.
There is some evidence of increased cardiovascular risk associated with long-term exposure, but despite a large number of subjects studied, the estimate of risk associated with true long-term LDX exposure in this study remains uncertain. However, the results do not require any further regulatory action. The current extensive contraindications and warnings regarding cardiovascular risk remain relevant.

data source and details