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.
