Merck and Schering-Plough got a boost from the FDA yesterday: The agency said patients using the cholesterol med Vytorin shouldn't stop taking the drug despite questions that have arisen since a two controversial studies were released last year. "Patients who are taking Vytorin without difficulty should continue until there's any further relevant information," American Heart Association President Dr. Timothy Gardner told the Associated Press.
As you know, last January's unveiling of the Enhance study--in which the Vytorin combo of simvastatin/Zocor and Zetia didn't appear to prevent heart disease any better than simvastatin/Zocor alone--set off a debate not just over the utility of Vytorin and Zetia, but about cholesterol drugs in general. Did lower "bad" cholesterol numbers necessarily translate into prevention of heart attack, stroke, and death?
Some theorized that statins such as Lipitor--which has some outcomes data supporting its preventive powers--were doing something other than simply lowering cholesterol, something that helped stave off heart and circulatory problems. So did Zetia, which works differently from statin meds, actually prevent cardiac trouble? Or just cut the numbers?
That debate is still raging, but after analyzing the Enhance data, the FDA says it found a significant difference in cholesterol levels between Vytorin and Zocor alone. And that's enough, the agency said, to recommend that patients continue using the combo pill. The Vytorin patients saw their LDL levels fall by 56 percent compared with 39 percent among the Zocor patients. Merck/Schering-Plough said in a statement that it is "pleased" that the agency has finished its review of Enhance. More debate-slash-analysis-slash-argument is sure to come.
- read the AP story