US Researchers to Expand Vytorin Study
By Anna Boyd
11:27, March 29th 2008
56 votes
Vote this story
US Researchers to Expand Vytorin Study

U.S. researchers announced Friday they would expand the size of a major study involving controversial cholesterol drug Vytorin, in order to determine its benefits.

Vytorin, marketed by a joint venture of Merck & Co. and Schering -Plough Corp., has come under fire because previous study raised questions about its effectiveness. The drug, combining a statin with a drug called Zetia did not slow progression of heart disease any more than a statin alone, preliminary results showed. These findings drove Vytorin prescriptions down 18 percent and slashed $49 billion from the drugmakers’ market value. The study, called Enhance is set to be presented Sunday at the big American College of Cardiology meeting in Chicago.

The researchers running the trial said in a statement they would expand the study to 18,000 patients to strengthen the results, which aim to show the drug prevents heart attacks and other heart problem by lowering a key measure of inflammation known as CRP. Higher levels of CRP are associated with a higher risk of heart attack. The study, originally designed for 10,000 patients, is expected to be completed in 2011.

Trial chairman Dr. Eugene Braunwald of Brigham and Women's Hospital said in a statement that expanding the trial will allow researchers to test definitively whether the additional lowering of low-density lipoprotein -- or LDL, the so-called bad cholesterol -- with Zetia will translate into additional benefits for patients, Reuters reports.

However, the move to increase the number of patients participating in the study could fuel controversy surrounding Vytorin. Its manufacturers were already criticized for making changes to the Enhance study midstream, and for attempting to change the study’s primary measure after it was completed.

They were also criticized for not releasing the Enhance results for nearly two years after its 2006 completion. But, the companies have defended their handling of the Enhance study and said the delay was caused by data-quality problems.

That did not fit the opinion of Michigan Democratic Reps. John Dingell, chairman of the Committee on Energy and Commerce, and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations who said they suspect the drugmakers suppressed the data to protect their profits.

They are still investigating the way Merck and Schering-Plough dealt with the situation and asked the U.S. Food and Drug Administration for records related to television commercials promoting the drug.



© 2007 - 2008 - eFluxMedia
dotclear

Other News in

St. John's Wort Can Be "as Good as Prozac"

Hamburg, Germany - St. John's Wort can be as good at lifting depression as pharmaceutical drugs such as Prozac, according to German researchers. A review of research evidence concluded that the...

Older Men Less Fertile than Younger Men

Hamburg - Older men trying to become fathers often discover that it's not as easily achieved as it is in youth. Usually the man's entire lifestyle comes into question when fertility is impaired,...

Asthmatic Children Should Carry an Emergency Plan

Heidenheim, Germany - Asthmatic children should always carry an emergency plan containing instructions on what to do if they have an asthma attack, the Heidenheim-based German Pneumologists...

John McCain and Barack Obama on the Improvement of Health

John McCain and Barack Obama on the Improvement of Health

One has to attentively analyze what the two candidates have to offer in their programs. John McCain and Barack Obama's health reform plans are different both in their approaches to solving problems...

E. Coli Contaminated Lettuce Came From California

E. Coli Contaminated Lettuce Came From California

Authorities claim that lettuce suspected in recent E. coli outbreak that sickened 36 people in Michigan came from California. Last month, the Michigan Department of Health said...

dotclear
Latest videos in Health
Israel helps Iranian cancer...
Kenyan women are in the pink
The White House Turns Pink
Teens 'chat' With Scientists...
NY Nursing Home Workers...

dotclear
Health You are here: Health
» Science   » Health   
E-mail To A Friend Print RSS Text size: Decrease font size Increase font size
dotclear
dotclear
dotclear
Most Popular in Health
German Farmer Recovering Well after Double Arm TransplantGerman Farmer Recovering Well after Double Arm Transplant

» read full story
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear
Today's Latest News
“My Own Worst Enemy” Generates Double Trouble“My Own Worst Enemy” Generates Double Trouble

» read full story
dotclear