After a one-year safety review of Vytorin, the FDA announced that patients should stay on Vytorin therapy.
According to the FDA – it has completed its one year review of the final clinical study report of ENHANCE. Following two years of treatment, carotid artery thickness increased by 0.011 mm in the Vytorin group and by 0.006 mm in the Simvastatin group.
The difference in the changes in carotid artery thickness between the two groups was not statistically significant.
However, the levels of LDL cholesterol decreased by 56% in the Vytorin group and decreased by 39% in the Simvastatin group. The difference in the reductions in LDL cholesterol between the two groups was statistically significant.
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.
Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the ENHANCE trial.
Last year, the news media played up Vytorin as a potentially dangerous therapy. Millions of patients that were benefiting from the therapy are no longer getting that benefit. The worry over Vytorin was actually a false alarm.
This is one more example that facts often conflict with emotion. The facts, this time, showed that the fear created by the misinformation on Vytorin in the press was way overboard.
The Washington Post: FDA Backs Cholesterol Drug Vytorin
CNN Money: FDA Completes Review Of Clinical Trial For Vytorin