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Vytorin fails to meet main goal of heart study
Reuters ^ | Jul 21, 2008 | Bill Berkrot and Ransdell Pierson

Posted on 07/21/2008 9:32:08 PM PDT by neverdem

The cholesterol fighter Vytorin sold by Merck & Co Inc and Schering-Plough Corp failed to meet the main goal of improving outcomes in a closely-watched heart study, according to data presented on Monday.

Slightly higher incidents of cancer deaths were also seen in those taking the drug -- 39 versus 23 on placebo -- although the lead researcher said those could have occurred as a result of chance.

The shares of both companies fell after the data were released, with Schering off more than 15 percent and Merck down by 7 percent.

No significant difference in the study's composite heart goals was seen between the patients who received Vytorin and those who received a placebo, according to data presented in London by its primary researcher, Dr. Terje Pedersen of Ulleval University Hospital in Oslo, Norway.

Researchers played down the cancer data, saying much larger studies of Vytorin have not showed increased cancer risk.

"There is no overall credible evidence of an increase in cancer," said Sir Richard Peto, professor of medical statistics and epidemiology at the University of Oxford, who reviewed the data. "We should not be diverted (from using Vytorin) by fears of cancer."

Merck and Schering-Plough delayed reporting quarterly financial results, which were expected on Monday morning, so investors could first learn about the outcome of the study.

The primary composite goals of the study of patients with irregular thickening of the main valve to the aorta were broken into...

--snip--

Vytorin was significantly better than placebo in reducing atherosclerotic events, defined as nonfatal heart attacks, need for coronary artery bypass surgery or artery-clearing procedures, hospitalization due to chest pain and strokes.

"The study has given a clear-cut answer whether lipid lowering will influence the cause of aortic stenosis and we can conclude it does not," Pedersen said...

(Excerpt) Read more at news.yahoo.com ...


TOPICS: News/Current Events
KEYWORDS: atherosclerosis; health; medicine; vytorin

1 posted on 07/21/2008 9:32:09 PM PDT by neverdem
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To: El Gato; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; Dianna; ...
BBC: Drug for deadly prostate cancer ( Limited Trials so far...but promising )

Scientists Figure Out How the Immune System and Brain Communicate to Control Disease

Poor children are more at risk for diabetes (Vote for a Marxist utopia.)

FReepmail me if you want on or off my health and science ping list.

2 posted on 07/21/2008 9:59:50 PM PDT by neverdem (I'm praying for a Divine Intervention.)
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To: neverdem

Vytorin was at the center of two seizures, my uncle and my father in law. Both are off the drug now, doesn’t matter how low your cholesterol levels are when you are dead.


3 posted on 07/21/2008 10:02:33 PM PDT by SFC Chromey (We are at war with Islamofascists inside and outside our borders, now ACT LIKE IT!)
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To: neverdem
I don't understand why it was ever postulated that a statin and Zetia would ameliorate the valve thickening in the first place. What is causing the thickening?

Most patients, of course, are not put on a statin for valve stenosis but for prevention and treatment of plaque blockages in the arteries, where statins continue to be effective including in this study.

Zetia is the suspect in the increaed cancer incidence, if it is not an artifact.

4 posted on 07/21/2008 10:11:20 PM PDT by steve86 (Acerbic by nature, not nurture™)
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To: SFC Chromey
Interesting, did either of their docs or anyone report the seizures to the FDA?

Reporting Adverse Experiences to FDA

5 posted on 07/21/2008 10:23:09 PM PDT by neverdem (I'm praying for a Divine Intervention.)
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To: steve86
I don't understand why it was ever postulated that a statin and Zetia would ameliorate the valve thickening in the first place. What is causing the thickening?

It's been 20 years since pathology for me, but my guess is that they were hoping that when you have calcific aortic stenosis from dystrophic calcification in the valve, that it is not unlike the dystrophic calcification in atherosclerotic arteries, which they are still blaming and betting on lowering the LDL-cholesterol.

6 posted on 07/21/2008 10:50:37 PM PDT by neverdem (I'm praying for a Divine Intervention.)
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To: neverdem

Sorry, anyone who takes these drugs should be also taking a “drug” that will grow braincells. Food is your medicine.


7 posted on 07/22/2008 2:47:36 AM PDT by AmericaUnited
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To: AmericaUnited

Yeah. Sure.

The objective of my switching from Lipitor to Vytorin (10:80) is to reduce LDL below 70 which coronary heart disease researchers consider life extending for those who have had a heart attack..

I had a damaging heart attack (LAD totally blocked) and coronary artery disease in 1974 at age 47. Then had six coronary bypass grafts in 1981.

I’m now 82 and functioning very well, thank you. Think I’ll stick with my cardiologist’s and electrophysiologist’s recommendations.

FMCDH!


8 posted on 07/22/2008 6:46:15 AM PDT by Ole Okie (Who are you going to believe anyway, Gore or your lyin' eyes?)
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To: Ole Okie

And let me guess... you didn’t make any other changes in diet or exercise, your body was just deficient in Vytorin?


9 posted on 07/22/2008 8:29:09 AM PDT by AmericaUnited
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