Vytorin Study: Disappointing Results

Researchers today reported disappointing results from a new
study of Vytorin , which combines the unique cholesterol drug Zetia with simvastatin, a traditional statin drug sold
generically and as Zocor .

The study included some 1,800 adults with aortic stenosis, a narrowing of
the the heart's aortic valve, a major
valve in the heart. The patients either took Vytorin or a placebo
drug.

Vytorin wasn't better than the placebo at reducing major heart
"events" such as death from heart
disease , hospitalization due to heart
failure , and the need for surgery to get the faulty heart valve
replaced.

However, Vytorin did lower LDL
"bad" cholesterol by more than 60% (the placebo didn't affect LDL cholesterol levels) and Vytorin did reduce clot-related
(ischemic) heart "events" such as nonfatal heart
attack, coronary bypass surgery, and clot-related strokes by 22%, compared
to the placebo, researcher Terje Pedersen, MD, PhD, of Ulleval University
Hospital in Oslo, Norway, said at a press conference in London.

The drug companies Merck and Schering-Plough jointly market Vytorin and
Zetia. Merck funded the study, Pedersen said.

A Merck spokesperson didn't
comment to WebMD in time for publication. But Schering-Plough chairman and CEO
Fred Hassan, when reporting the company's financial results for the second
quarter of 2008, said, "We remain confident in Vytorin and Zetia and the
ability of these medicines to lower LDL
cholesterol."

Schering-Plough spokeswoman Mary
Fran Farajii tells WebMD that Schering-Plough "was not surprised" that
Vytorin didn't reduce valve replacement surgery in the aortic stenosis
patients. "This was a trial investigating whether intensive lipid lowering
would reduce that need and nothing else has proven the ability to do so,"
says Faraji. She adds that the finding that patients taking Vytorin were less
likely to have an ischemic heart event was "encouraging."

In
January , the drug companies Merck and Schering-Plough, which jointly market
Vytorin and Zetia, issued preliminary results from their ENHANCE study, which
included people with genetically high LDL "bad" cholesterol levels.

The ENHANCE study's early results showed that Vytorin wasn't better than
simvastatin alone for reducing plaque buildup in the carotid arteries, which
supply blood to the brain. In fact, patients taking Vytorin had slightly more
plaque buildup during the trial than those taking simvastatin alone, despite
the fact that the Vytorin patients had lower levels of LDL "bad"
cholesterol.

Soon after Merck and Schering-Plough announced those early findings in
January, the
FDA said it would review the study's data. That review is still
underway.

By Miranda Hitti
Reviewed by Brunilda Nazario
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