Vytorin takes a big hit...

[J.R.E.]

That was the head lines in todays St. Petersburg times. Here's the article. Ed( my partner ) was just placed on Vytorin about 3 weeks ago. He's going to call his doctor and see whats up...

http://www.sptimes.com/2008/01/15/Worldandnation/Vytorin_takes_a_big_h.shtml


Vytorin takes a big hit
Study finds the cholesterol drug doesn't slow plaque growth.
By Washington Post
Published January 15, 2008


--------------------------------------------------------------------------------
 

 
WASHINGTON - A popular cholesterol-lowering drug failed to help slow the buildup of artery-clogging plaque in a long-awaited study, the companies that market the medication said Monday, raising questions about whether its use should be limited.

The drug, Vytorin (a combination of Zetia and Zocor), also did not reduce the thickness of plaque lining artery walls, a significant disappointment for the manufacturers. The results will add to the growing concern over Zetia and Vytorin.

"Obviously we would have preferred a more favorable result," said Skip Irvine, a spokesman for Merck/Schering-Plough Pharmaceuticals, a joint venture between the two companies that markets both Zetia and Vytorin.

Other experts said the findings mark a major blow for the medications.

"This is stunning," said Steven Nissen, a Cleveland Clinic cardiologist who was not involved in the research. "I do not believe it should be used as a first-line therapy. It should only be used as a last resort. That's a stunning reversal for what was previously one of the fastest-growing cholesterol-lowering medications being used."

The companies disputed Nissen's conclusions, saying the study showed again that Zetia was highly effective at lowering cholesterol levels, by 15 to 20 percent in most patients.

The companies are sponsoring another large study aimed at evaluating the drug's ability to prevent heart attacks and strokes. That study is expected to be completed in 2011, Irvine said.

After their approvals in 2002 and 2004, Zetia and Vytorin quickly became popular, and their use has continued to grow, according to IMS Health, a health care information company.

Previous studies have shown Zetia and Vytorin are effective at lowering cholesterol, but other medications that do this have been shown to have additional benefits, such as slowing the buildup of plaque or sometimes even shrinking it, as well as reducing the risk of heart attacks and strokes and lowering mortality rates.

The new company-sponsored study was the first attempt to demonstrate Vytorin's ability to slow the progression of heart disease. It involved 720 patients in Europe suffering from a genetic condition that causes very high cholesterol levels. About half of the patients received Vytorin, and the other half got Zocor alone.

After two years, ultrasound measurements of plaque build-up in neck arteries found no significant difference between the groups, and indicated that those receiving Vytorin may have experienced slightly more build up.

"This is as bad a result for the drug as anybody could have feared," Nissen said. Millions of patients may be taking a drug that has no benefits for them, raising their risk of heart attacks and exposing them to potential side effects, he said.

There were no signs that patients taking Vytorin were any likelier to suffer side effects or heart problems, but Nissen and others said the study suggests that the medications deny patients the additional benefits of drugs such as Lipitor and Crestor.

"Whenever you use an ineffective treatment it means you are denying them effective treatments," Nissen said.

The companies have come under criticism from cardiologists and members of Congress for failing to release the findings sooner. They completed the trial in April 2006 and planned to release the findings by March 2007.

Both companies' stocks were down in trading Monday, with Merck's shares down 77 cents to $59.78, and Schering-Plough's down nearly 8 percent to $25.52. Zetia and Vytorin are important contributors to both companies' profits, especially to Schering, which is smaller and less profitable than Merck.

Analysts estimate that 70 percent of Schering's earnings depend on the drugs, and Merck is trying to repair its reputation after withdrawing the painkiller Vioxx from the market in 2004.

Information from the New York Times was used in this report.

Fast facts:

What the findings mean

There were no signs that patients taking Vytorin were more likely to suffer side effects or problems, but Steven Nissen, a Cleveland Clinic cardiologist not involved in the research, and others said the study suggests that prescribing the drugs denies patients the benefits of drugs such as Lipitor, Zocor and Crestor. Patients should not be prescribed Zetia unless all other cholesterol drugs have failed, he said.

About the drugs

Vytorin and Zetia are among the most commonly prescribed cholesterol-lowering drugs.

Zetia: Approved in 2002, about 14-million prescriptions were written in 2006.

Vytorin: About 70 percent of patients who take Zetia do so in the form of Vytorin, which is a combination of Zetia and Zocor. Approved in 2004, about 18-million prescriptions were written in 2006


Ray

[Jody]

My doctor said Zocor conflicts with some HIV meds and so he doesn't prescribe it...He loves Lipitor for cholesterol lowering and mine has gone down to 156 total and triglycerides and HDL and LDL are good too...My cholesterol used to be anywhere from 225 to 275 at times even with exercise and some dietary modifications so I guess the Drano really does work. 

Jody

[J.R.E.]

Yeah, Ed's going to contact his doctor in a few days. Meanwhile there was this follow up article, also on the front page of the St. Pete Times this morning :

http://www.sptimes.com/2008/01/16/Southpinellas/Consult_doctor_about_.shtml


Consult doctor about Vytorin
Don't quit cholesterol drug Zetia or related Vytorin without your doctor's permission.
By CHANDRA BROADWATER, Times Staff Writer
Published January 16, 2008


--------------------------------------------------------------------------------

 
ST. PETERSBURG - Confused patients kept the phone lines busy Tuesday at the offices of local cardiologists.

Should I stop taking Vytorin? What about Zetia?

The confusion stems from the results of a long-awaited study that found that the widely popular Zetia, a cholesterol-lowering drug, failed to reduce the growth of artery-clogging plaque as thought. Simply put, the drug that is prescribed to about 1-million people a week doesn't work.

While the study brings into question the use of Zetia alone, it also raises concerns over the use of Vytorin, which combines Zetia with the statin Zocor.

What should patients do? Dr. Peter Wassmer, cardiologist and chief of staff at the Tampa Bay Heart Institute at Northside Hospital, urges people not to panic:

 

What are you hearing from patients?

Basically, whether they should stop taking the drugs or not. The answer is no. Continue taking your medications as prescribed and talk to your doctor.

 

Should patients taking Zetia be concerned?

It was thought that because Zetia lowers cholesterol, that it could be used as a stand-alone for patients with heart disease. The idea was that since it lowers cholesterol levels, then it could have a possible impact on the prevention of heart disease.

Unfortunately, A plus B does not equal C. Patients who are taking Zetia alone, with the idea that it will prevent future coronary events, might need to be on a statin. They should ask their doctors.

 

What is the difference between how a statin works and how Zetia works?

Statins are drugs that have been shown to stop coronary plaque and decrease the risk for heart attacks. They work by preventing the production of bad cholesterol LDL in the liver and stabilize the plaque or cholesterol that deposits in the heart vessels. Most heart attacks are caused by plaque ruptures that block the vessels, and statins make it less prone to ruptures.

While Zetia does lower cholesterol levels by preventing the absorption of cholesterol in the stomach, this study shows that it does not stabilize plaque like statins do. It appears that by itself, it does not lower future risks of coronary events.

 

What about those who are taking Vytorin?

The Zocor portion of Vytorin works fine. The Zetia portion is neutral. If a patient's lipid and cholesterol levels look fine, then I would leave them on it. But everyone's different. Some people can't handle higher doses of statins and complain of muscle aches and other side effects. That's one of the reasons why the Vytorin combination was promoted the way it was. They thought that it might be possible to get away with lower doses of Zocor. Again, talk to your doctor.

 

Does Zetia increase the risk of coronary disease?

No, the study did not show that there are any other side effects caused by its use. It just essentially shows that when it comes to preventing heart disease, it's a placebo. It's not harmful and does have benefits such as reducing cholesterol. This is nothing like the Vioxx deal, where people died.

 

Do you have any other suggestions for concerned patients?

Just make sure to call your physician and ask them any questions you might have. And the last thing anyone should do is stop taking medications.

Information from the New York Times was used in this report. Chandra Broadwater can be reached at cbroadwater@sptimes.com or (352) 848-1432.

 

About the study

A clinical trial of Zetia, a cholesterol-lowering drug used in combination with Zocor to create the drug Vytorin, failed to show that the drug reduces growth of fatty plaque in arteries that can cause heart problems, according to Merck and Schering-Plough Pharmaceuticals.

The trial, called Enhance, covered 720 European patients with a gene that causes them to produce very high levels of low-density lipoprotein, called LDL, or bad cholesterol. Patients in the trial had LDL levels that were three times the level cardiologists recommend.

Completed in 2006, the two-year study showed that patients who took Zocor alone reduced their LDL by 41 percent on average. Patients who took Vytorin reduced their cholesterol by 58 percent.

Yet despite the larger cholesterol reduction, patients taking Vytorin had more fatty plaque growth in their carotid arteries than those on Zocor




Ray

[BT65]

Ray, I've been on Lipitor for almost a year and it has worked wonders with my cholesterol.  My triglycerides remain elevated, but I'm also diabetic and the doctor said that's why they're still elevated.

[J.R.E.]

Ray, I've been on Lipitor for almost a year and it has worked wonders with my cholesterol.  My triglycerides remain elevated, but I'm also diabetic and the doctor said that's why they're still elevated.

Hello Betty,

Thats Great news !! You and Jody both, doing pretty good on Lipitor. I've been on Zocor, symvastatin, crestor and now finally Lipitor, so I am also hoping for those good results ! We'll find out next week ! I had some difficulties on all of them except lipitor...


Take care----Ray

[aztecan]

Vytorin was the drug that didn't play well with Crixivan and caused me no end of physical problems.

I still take Zetia and Pravastatin. I had too many side effects from Lipitor.

Good luck with it though.

HUGS,

Mark