Study: Drug doesn't help heart
By STEVE STERNBERG • Gannett News Service • July 22, 2008
The blockbuster cholesterol-lowering drug Vytorin failed to slow age-related hardening of the heart valve that without surgery can lead to heart attack, stroke or death, doctors said Monday.
Vytorin worked no better than a placebo at blocking aortic stenosis, which leads to 95,000 valve replacement operations and 25,000 deaths in the USA each year, says lead investigator Terje Pedersen of Ulleval University Hospital in Olso.
"We can conclude it will not affect the course of aortic stenosis," Pedersen says.
The study was designed to determine whether reducing a major risk factor for aortic stenosis, the build-up of plaque in arteries supplying the heart, might prevent valve damage. Within five years of diagnosis, most patients undergo surgery, develop heart failure or die.
But the study did not answer the most important question: Whether Vytorin prevents heart attacks, strokes and deaths in patients suffering from coronary artery disease. "The jury is still out," says Robert Califf, head of clinical research at Duke University and a lead investigator in an 18,000-patient trial designed to provide an answer but won't produce results until 2012.
Vytorin was approved in 2004 based on its power to lower cholesterol. Researchers raised questions about Vytorin's effectiveness in January when they reported the drug -- a combination of cholesterol-lowering simvastatin and ezetimibe that blocks cholesterol absorption in the kidney -- was no better at preventing carotid artery blockages than simvastatin alone.
Although there were slightly more cancer deaths in patients taking Vytorin, an analysis concluded there is "no credible evidence" for a cancer link.
The blockbuster cholesterol-lowering drug Vytorin failed to slow age-related hardening of the heart valve that without surgery can lead to heart attack, stroke or death, doctors said Monday.
Vytorin worked no better than a placebo at blocking aortic stenosis, which leads to 95,000 valve replacement operations and 25,000 deaths in the USA each year, says lead investigator Terje Pedersen of Ulleval University Hospital in Olso.
"We can conclude it will not affect the course of aortic stenosis," Pedersen says.
The study was designed to determine whether reducing a major risk factor for aortic stenosis, the build-up of plaque in arteries supplying the heart, might prevent valve damage. Within five years of diagnosis, most patients undergo surgery, develop heart failure or die.
But the study did not answer the most important question: Whether Vytorin prevents heart attacks, strokes and deaths in patients suffering from coronary artery disease. "The jury is still out," says Robert Califf, head of clinical research at Duke University and a lead investigator in an 18,000-patient trial designed to provide an answer but won't produce results until 2012.
Vytorin was approved in 2004 based on its power to lower cholesterol. Researchers raised questions about Vytorin's effectiveness in January when they reported the drug -- a combination of cholesterol-lowering simvastatin and ezetimibe that blocks cholesterol absorption in the kidney -- was no better at preventing carotid artery blockages than simvastatin alone.
Although there were slightly more cancer deaths in patients taking Vytorin, an analysis concluded there is "no credible evidence" for a cancer link.
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Comment by Imsurvivor on July 23, 2008 at 12:32am -
You don't say. I think a lot of drugs these days (if not all of them) are nothing more then the "magical potions" of the old days brought into the present. New medications seem to be coming out every day, and the majority of them are 100% crap. Look at all the recalls. Man, the drug companies really have the general population wrapped around their little greedy fingers.
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