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Data About Zetia Risks Was Not Fully Revealed

New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results. Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.

Summary: Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins

Most of the millions of people who use Zetia take it along with a statin like Lipitor, Crestor or Zocor. Or they take it in a single pill, Vytorin, that combines Zetia with Zocor.

The discovery of the unpublished research comes as Merck and Schering are already under criticism for not yet releasing data from an important Zetia study, called Enhance, that they completed early last year.

The Enhance data may also contain important information about Zetia’s liver risks.

At least some patients were dropped from the Enhance study after testing revealed that they had elevated liver enzymes, a Schering-Plough spokesman confirmed this week. But a full report on that trial, including the number of patients who had liver problems, will not be available until March.

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&contentvalue=1656696&channelID=26
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FACT: NEW CASES OF TYPE 2 DIABETES SKYROCKET:  The Center for Disease Control chronicles a 153 percent increase in diabetes diagnoses from 1994 to 2005. Dr. Fadi Yacoub, a nephrologist with Internists Associates of Iowa, says, but there is “no question about it” that Type II Diabetes has “skyrocketed for one single reason – weight. The more weight the more diabetes the more kidney disease.”  Dr. Alan Reed, chief of the division of transplantation at University Hospitals and director of its organ transplant center, says, “All you have to do,” Reed says, “is look at the number of people on dialysis and waiting for transplants. There are 20.8 million children and adults in the United States, or 7 percent of the population, who have diabetes, including 6.2 million people (or nearly one-third) who are unaware that they have the disease. Add to that the 54 million people in the United States who have pre-diabetes. Recent research has shown that some long-term damage to the body, especially the heart and circulatory system, may already be occurring during pre-diabetes.