Vytorin study to continue after review; Merck shares jump

Tue Mar 12, 2013 11:13am EDT

A view of the Merck & Co. campus in Linden, New Jersey March 9, 2009. REUTERS/Jeff Zelevansky

A view of the Merck & Co. campus in Linden, New Jersey March 9, 2009.

Credit: Reuters/Jeff Zelevansky

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(Reuters) - An independent monitoring board said a large trial of Merck & Co's Vytorin cholesterol drug can continue, suggesting no major safety issues have yet been seen with the pill.

The news eased investor concerns that a safety issue could arise and further hurt sales of already struggling Vytorin. Merck shares were up 3.7 percent in Tuesday morning trading.

"We believe it is increasingly difficult to suggest any safety issues with (Vytorin)," JPMorgan analyst Chris Schott said, in view of the panel's green light to continue with the study.

Such panels of medical experts, which are allowed to examine confidential clinical trial data, are routinely used to assess whether drug studies should continue or be halted because they have already proven a drug is effective, ineffective or has safety problems.

Investors have been avidly awaiting an update from the panel on the study of Vytorin, called IMPROVE-IT, which began in 2005 and involves more than 18,000 patients with well-controlled cholesterol who had heart attacks or the kind of chest pain that can precede heart attacks.

The study will now continue until its planned conclusion in September 2014, Merck said on Tuesday. The study aims to prove conclusively whether Vytorin, whose annual sales total $1.75 billion, can significantly reduce heart attacks, strokes and heart-related deaths compared with Merck's older, generically-available Zocor (simvastatin) cholesterol fighter.

"Getting this interim look out of the way is a positive, given where investor sentiment has been," Sanford Bernstein analyst Tim Anderson said in a research note. He said "a surprising number of investors" have been worried about potential safety issues with Vytorin.

Doubts about the true worth of Vytorin and a related Merck drug called Zetia, and debates about their safety, have hurt sales of the medicines since 2008, after a pair of smaller studies showed unfavorable trends.

Vytorin combines Zocor with Zetia, a $2.6 billion-a-year product that Merck also sells as a standalone treatment. Zetia and Zocor block "bad" LDL cholesterol through different mechanisms, the reason they are paired in Vytorin.

The IMPROVE-IT study was begun in 2005, a year after Vytorin was introduced, to get a far better picture of the combo drug's worth and safety than could be seen in earlier trials that led to its approval.

Merck investors are hoping the final IMPROVE-IT results next year will establish Vytorin's clear effectiveness and safety, and thereby spark revived sales of Vytorin and Zetia.

Merck shares were up $1.60 to $45.26 in morning trading on the New York Stock Exchange.

(Reporting By Ransdell Pierson and Caroline Humer; editing by John Wallace)

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Comments (1)
Paul5 wrote:
This article is bunk. I was doing fine with Lipitor until an unscrupulous cardiologist insisted that I use Vytorin. This was following a successful open heart surgery. A few weeks following the initial ingestion of the Vytorin, I was realizing all sorts of major muscular pain all over my body. I immediately went to my primary care physician who proceeded with several tests as no one at that time knew of the bad side effects of Vytorin and I was taking a slew of prescriptions to help bring me out of the heart attack problem. This apparently threw all of the physicians a curve ball as none of them were able to diagnose the Vytorin as the culprit. Not until January of 2008 was the cause of my excruciating muscular pain defined and it was by my pharmacist who explained that the manufacturer of Vytorin had just released a study that was completed back in April 2006. I immediately quit taking Vytorin and my upper body began to resolve. However, no matter how long I waited, and no matter what I did to mitigate the problem, my lower body never followed and to this day the Vytorin induced muscular pain remains in my entire lower body. In addition to this, a condition called Rhabdomyolysis has taken effect and is a condition directly linked to the Vytorin.
I’ve met all sorts of people who have experienced the same thing, but the Big Pharma companies don’t want to admit to their failure. Those that were on Vytorin only a short period, perhaps up to 12 weeks may have had their bodies resolve, but those who were on the drug longer, perhaps a half a year or longer still have residual effects, and yes, even death which occurred to a friend who had been on the drug since its release in 2004. A release which should not have happened as the drug had not been tested. The study that did occur, called ENHANCE, was a short term study of only 12 weeks and involved about 3400 persons. Those persons who showed negative side effects during the study were dropped so that they were not included in the final results. Since that time, to the best of anyone’s knowledge that I have discussed this case with, there has been no long term study except informally by those of us who continue to suffer from the Vytorin induced side effects. This IMPROVE-IT study supposedly started in 2005 before their ENHANCE study was even completed is a crock. Don’t ever agree to take Vytorin as you will be just rolling the dice with your life. See other studies on-line studied and published concerning the problems with this drug.

Mar 13, 2013 10:02am EDT  --  Report as abuse
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