Merck's Vytorin cuts heart risk moderately
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Taking the cholesterol-lowering drug vytorin can moderately reduce risk of heart attack or myocardial infarction, stroke and cardiac arrest in patients with chronic kidney disease or nephropathy, according to a new clinical trial.
Vytorin is made by Merck& Co. of and is a combination of Zetia and simvastatin, two cholesterol-lowering drugs.
Based on the trial results, Merck was cited as saying it will seek regulatory approval to market the product to patients with chronic kidney disease in the United States.
The trial compared Vytorin with a placebo and the trial results could not tell whether adding Zetia to simvastatin improves its efficacy or not.
Critics say Vytorin is no more effective than simvastatin; in other words, adding Zetia does not improve the efficacy in reducing the risk of heart attack and stroke.
"These results don't provide any insight into whether [Zetia] is beneficial," Steven Nissen, chairman of the cardiovascular department at the Cleveland Clinic was quoted as saying.
Generic cholesterol lowing drugs or statins based on simvastatin are available from a several manufacturers.
According to the Wall Street Journal, sales of vytrin and Zetia have dropped over the last three years, which may have prompted the drug maker to find new applications to promote sales of vytorin.
The new trial led by Oxford university researchers included about 9,000 people with chronic kidney disease. People with this disease are at high risk of cardiovascular disease and the new trial was intended to find if cholesterol lowering drug vytorin can help reduce the risk.
Colin Baigent of the clinical-trial division of Oxford University and colleagues found about 15 percent of those who used vytorin suffered myocardial infarction or stroke, compared to 18 percent among those who took a dummy drug.
In other words, compared with those who took a placebo, those who took vytorin were 17 percent less likely to suffer myocardial infarction or stroke.
There is some safety concern about vytorin. The FDA in Aug 2008 issued an Early Communication describing a possible association between using vytorin and elevated risk of cancer and cancer-related death. The association was found in the Simvastatin and Ezetimibe (zetia) in Aortic Stenosis (SEAS) trial.
In 2009, the agency said it completed its review on the safety issue and stated on its website "It is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out."
The new trial, according to Wall Street Journal, didn't find any increased risk of cancer among patients using vytorin during the 4-year trial.
It takes years for a cancer to develop into something that is clinically significant and no one knows if cancer would develop in the patients years later.
Alternative preventative against heart disease
Those who would like to try alternative preventaives should follow the healthy diet Dr. Dean Ornish uses to help people prevent heart disease. It is highly effective maintain a restrictive diet to prevent cardiovascular disease. Dr. Ornish is a professor of University of California - San Francisco.
In addition, vitamin D can be another vital option. A new study published in the Oct 1, 2010 issue of American Journal of Cardiology suggests taking vitamin D supplements may help cut the risk of a series of heart conditions.
Anderson J.L. and colleagues, authors of the study, of Intermountain Medical Center in Murray, Utah found "The vitamin D levels were also highly associated with coronary artery disease, myocardial infarction, heart failure, and stroke, as well as with incident death, heart failure, coronary artery disease/myocardial infarction, stroke, and their composite."
This is not the only study that suggests that vitamin D may help prevent heart disease.
By David Liu and editing by Rachel Stockton
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