Study Casts Doubts on Vytorin, Zetia
Cholesterol-Lowering Drugs May Not Reduce Plaque Buildup
WebMD News Archive
Schering-Plough Responds continued...
Davies says three larger ongoing trials, involving some 20,000 patients,
should answer questions about whether Zetia and Vytorin prevent more adverse
events and deaths than statins alone.
He questions the reaction to the ENHANCE results, which he called a
"small, academic trial."
"The implications drawn from the findings in terms of clinical use seem
out of proportion to what the trial was designed to demonstrate," he says.
"One should keep in mind that while statins are the first-line therapy for
most people, they are not enough for many people and are not appropriate for
some. There is a need for viable alternatives, and Zetia and Vytorin have
proven to be very effective for lowering LDL levels."
Combined quarterly sales of Zetia and Vytorin reached $1.3 billion in the
second quarter of 2007, with Vytorin sales growing by 30% and Zetia sales
increasing by 21%, according to the Dow Jones news service MarketWatch.
Docs Weigh in
A statement released Tuesday afternoon by the American College of Cardiology
(ACC) urged patients taking Zetia or Vytorin to remain calm in the wake of the
The statement made it clear that ACC still considers Zetia a reasonable
option for patients who cannot tolerate statin drugs or can only tolerate
"There is no reason for patients to panic," the statement read. "Concerned
patients using these drugs should talk to their health care professional. This
is not an urgent situation and patients should never stop taking any prescribed
medications without first discussing the issue with their health care
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