A new study found, Vytorin sold by Merck & Co Inc and Schering-Plough Corp, used for the treatment of high cholesterol, failed to prevent the worsening of heart disease or to lower the need for surgery in patients with heart valve disorders.
The often deadly condition, common among elderly people, involves partial blockage and stiffening of the aortic valve, which directs blood flow to part of the heart.
An estimated 2 percent of people 65 or older have the condition, which can lead to heart failure.
The new data did little in the way of removing doubt that was cast over Vytorin from a previous study in January that suggested the combination drug failed to work any better than that of the cheaper generic statin.
The study found no substantial difference in the composite heart goals between patients who received Vytorin and those given a placebo, according lead researcher, Dr. Terje Pedersen of Ulleval University Hospital in Oslo, Norway.
Slightly higher cancer deaths were seen in those patients taking the Vytorin – 39 compared to 23 on placebo- in the new study, although Pedersen said those could be mere coincidence. Previous Vytorin studies have not showed an increased risk of cancer.
At this time there is no creditworthy evidence that supports an increase in cancer risk, said Sir Richard Peto, professor of medical statistics and epidemiology at the University of Oxford.
A trial on a larger scale is needed to guide us on how to best use this drug, said Harlan Krumholz, a researcher from Yale University, adding: “In the meantime, doctors and should be advised that while the drug does lower cholesterol levels, there is substantial uncertainty about the effects of the drug.”
Although a larger trial is underway, the results will take years.
Vytorin was better than the placebo in reducing the need for coronary artery bypass surgery, nonfatal heart attacks or artery clearing procedures and hospitalization resulting from chest pains and strokes.
In comparison the drug was no better than the placebo at reducing aortic valve disease events which include – valve replacement surgery, hospitalization due to heart failure and cardiovascular death.
The drug did work to decrease diseases that affect arterial blood vessels, which is basically what researchers were expecting to find. Vytorin lowered LDL cholesterol by 61 percent throughout the study.
The SEAS Study (Simvastatin and Ezetimibe in Aortic Stenosis), made up of 1,873 patients was designed to determine if intensive cholesterol lowering can help to reduce the need for surgical of aortic valve replacement and reduce cardiovascular events in people that suffer from aortic stenosis.
Study findings presented a clear and decisive answer - “no, it does not,” Pedersen said. He does note, however, that Vytorin can offer patients some benefits in helping to reduce the risk of coronary artery disease.
An earlier study, called ENHANCE, found Vytorin was no better at reducing plaque buildup then generic brand Zocor which has been on the market for two years.
Two congressional committees have been investigating whether the companies deliberately delayed releasing data to boost Vytorin sales, which both companies sharply deny.
After details from the ENHANCE study began surfacing in March, prominent cardiologists began urging doctors to go back to older, well proven treatments for high cholesterol.