Vytorin Has Double Duty

Vytorin recommended for some kidney disease patients to protect against harmful cardiovascular events

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Kidney disease patients face a high risk of heart-related events like stroke. As such, patients need ways to protect against potentially deadly problems. Now, health advisors are backing a drug that does just that.

A panel of experts supports the use of the cholesterol-lowering drug Vytorin (ezetimibe and simvastatin) for preventing heart-related problems in kidney disease patients. However, the panel did not recommend the drug for patients on dialysis.

"Talk to your doctor or pharmacist about taking Vyortin."

Vyortin - which is marketed by Merck - is already approved for lowering cholesterol. Now, Merck wants to get the drug approved for preventing heart problems in kidney disease patients, a population that is at high risk for cardiovascular events.

The FDA brought together a panel of experts to see if Vytorin would be safe and effective for kidney disease patients. Looking at the evidence, the panel decided that the drug could be used to prevent stroke and other heart-related issues in chronic kidney disease patients, but not in patients on dialysis for end-stage renal disease (near or total loss of kidney function).

A recent trial showed that Vytorin may lower the risk of major cardiovascular problems like stroke, heart attack, and heart disease. However, that effect is not nearly as strong in end-stage renal disease patients as it is in patients who still do not need dialysis. As a result, the panel voted not to recommend Vytorin for dialysis patients.

"I've not said that this is a no," Dr. Robert Smith, a Brown University professor, told Reuters. "I just feel the data are equivocal and do not support approval for that specific use."

According to Dr. David Gordon, of the National Institutes of Health and one of the panel members, there is not really enough evidence to say that the drug will be good for one group and not the other. At the same time, there is not enough evidence to say this drug would be good for dialysis patients.

The recent trial involved almost 9,500 patients for about five years. It showed that Vyortin reduced the risk of major heart-related problems by 16 percent in chronic kidney disease patients.

Researchers found that 6.2 percent of patients taking Vytorin eventually needed surgery to open blocked arteries. In comparison, almost 8 percent of those taking placebo needed similar surgeries. Of the patients taking Vytorin, 3.5 percent had a stroke, compared to 4.6 percent of those taking placebo.

Participants taking Vytorin were categorized into two groups: pre-dialysis patients and those on dialysis. Pre-dialysis patients had a 23 percent lower risk of major heart-related events, while patients on dialysis had only a six percent reduction in risk.

The FDA has yet to make a decision on the future of Vytorin as a defense against major cardiovascular events, but it usually listens to its advisory panels.

Reviewed by: 
Review Date: 
November 3, 2011
Last Updated:
November 4, 2011