Study Casts Doubts on Vytorin, Zetia
Cholesterol-Lowering Drugs May Not Reduce Plaque Buildup
Docs Weigh in continued...
Michael Blazing, MD, of Duke University Medical Center, is lead investigator
of the largest ongoing trial of Zetia, sponsored by Merck and
The study will include more than 10,000 people recently hospitalized for a
heart attacks or unstable angina randomized to receive either Zetia and
simvastatin or simvastatin alone.
Patients will be followed to record the incidence of major cardiovascular
events, including heart attacks or strokes.
Blazing tells WebMD that study should be completed by 2012.
"In order to really answer the questions about the safety and efficacy, we
need much bigger trials like ours with these major events as the endpoints," he
Shah agrees, adding that he sees no reason why anyone taking Zetia and
Vytorin should stop taking the drugs based on the ENHANCE results.
"Do (Zetia and Vytorin) save more lives? Do people who take them have fewer
heart attacks and strokes?" he asks. "The answer to these questions will tell
us if these drugs are useful, and we don't yet know the answers."
But Nissen says it's wrong for the drug companies to continue to make
billions of dollars a year from the sale of Zetia and Vytorin when there is no
evidence that they work any better than generic statins, which cost much
"We are supposed to continue giving these drugs on faith for the next four
or five years in the hope that they work," he says. "That makes no sense. We
practice evidence-based medicine, and right now the only evidence we have
suggests that (Zetia and Vytorin) add nothing in terms of health benefits."