Vytorin Study: Disappointing Results
Cholesterol Drug Vytorin Misses Study's Main Mark but Shows Some Benefits
July 21, 2008 -- 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.