Patients should not stop taking Vytorin or other cholesterol lowering medications," the FDA announced following review of the ENHANCE trial.
ENHANCE showed that despite Vytorin's lowering LDL cholesterol levels more than simvastatin (Zocor) after 2 years, there was no significant difference between these groups in carotid intima-media thickness.
"The results from ENHANCE do not change FDA's position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease," the agency wrote in a safety update posted on its website.
An ongoing study (scheduled for completion in 2012) aims to determine whether ezetimibe/simvastatin actually decreases the risk for cardiovascular events, compared with simvastatin alone. In addition, the FDA is still reviewing data from the SEAS study, which indicated that Vytorin may be associated with increased cancer incidence and cancer mortality.
No comments:
Post a Comment