Study Casts Doubts on Vytorin, Zetia
Cholesterol-Lowering Drugs May Not Reduce Plaque Buildup
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 ENHANCE findings.
The statement made it clear that ACC still considers Zetia a reasonable option for patients who cannot tolerate statin drugs or can only tolerate low-dose statins.
"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 professional."
Michael Blazing, MD, of Duke University Medical Center, is lead investigator of the largest ongoing trial of Zetia, sponsored by Merck and Schering-Plough.
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 says.