I'm switching from Vytorin to Lipitor.
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MONDAY, Jan. 14, 2008 (HealthDay News)-- The long-awaited results of a trial of Zetia, a cholesterol-lowering drug prescribed to about a million Americans, shows the drug confers no medical benefit to users.
In fact, the pace at which artery-clogging plaques formed within vessels almost doubled in patients taking Zetia (ezetimibe) along with another cholesterol-lowering drug, Zocor (simvastatin), compared to those taking Zocor alone, the study found.
The two medications -- ezetimibe plus simvastatin -- are also marketed in one prescription pill, called Vytorin. About 60 percent of U.S. patients who are taking Zetia now receive the drug as part of Vytorin.
But the new two-year trial of 720 patients sheds doubt on whether it makes any sense for people battling cholesterol to take Vytorin versus Zocor alone, experts said. The study was funded by the two companies that make Zetia, Merck and Schering-Plough.
"This wraps it up," said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic. "That's all there is. There just isn't any evidence that adding ezetimibe to simvastatin produces any advantage."
The study also noted that the speed at which arteries thickened with plaque almost doubled among those on the two-drug regimen compared to those taking Zocor alone.
Now that the results have arrived, Zetia and Vytorin should be viewed as "drugs of last resort," for patients not helped by standard statin therapy, Nissen said. Only if you can't tolerate full doses of simvastatin should you take ezetimibe, he said.
news.yahoo.com
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Nov 15, 2005
Researchers didn't find the main difference they sought — fewer "major coronary events" in the Lipitor group during an average follow-up of almost five years. That category lumped together cardiovascular deaths, nonfatal heart attacks and nonfatal cardiac arrest. These events totaled 463 in the Zocor patients and 411 in the Lipitor patients, a difference that was not statistically significant.
Other studies that have shown more aggressive lipid lowering results in fewer cardiovascular problems have also measured the incidence of stroke, which the most recent trial did not. The failure to measure stroke could be one reason the study failed to show a statistically significant difference, doctors said.
The study did show Lipitor reduced nonfatal heart attacks by 17 percent and angiograms and bypass surgery by 23 percent, said Dr. John Tsai, leader of Pfizer's worldwide Lipitor team. Tsai said the study's individual categories show Lipitor's ability to significantly lower cholesterol provides better results for patients.
The new ENHANCE trial -- which involved patients with a genetic condition that causes abnormally high levels of blood cholesterol -- found no such added benefit. According to a statement released by the two drug companies Monday, researchers found no statistically significant difference in heart attacks or stroke among trial participants who took Zetia plus Zocor, a widely used cholesterol-lower drug, versus those who got Zocor alone.
cbs2chicago.com
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June 10, 2006
At the recommended usual starting doses of both agents, VYTORIN 10/20 mg demonstrated a 53.6 mean percent reduction from baseline in LDL cholesterol as compared to a 38.3 percent reduction observed with Lipitor 10 mg and a 44.6 percent reduction with Lipitor 20 mg. At the alternative starting dose for patients requiring greater LDL lowering for the two agents (> 55 percent for VYTORIN and > 45 percent for Lipitor), VYTORIN 10/40 mg, decreased LDL cholesterol significantly more than Lipitor 40 mg -- 57.6 percent compared to 50.9 percent, respectively, (p<0.001 for all three comparisons).
schering-plough.com
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January 14, 2008: 03:13 PM EST
The results could prove to be a mixed blessing for Merck and Schering-Plough, which have a joint venture that markets both Vytorin and Zetia. Strong sales of the drugs have helped fuel both companies' rising profits and stock prices over the past couple of years, though the drugs' growth rates have slowed. The new study could jeopardize further sales growth.
"What a lot of people are going to conclude is there's just no reason to prescribe it when you get the same benefit from a drug that is much cheaper and has been around for a long time," said Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.
Merck shares recently fell $1, or 1.7%, to $59.55. Schering-Plough shares were off $1.97, or 7.1%, at $25.76. Schering-Plough, Kenilworth, N.J., also released results of a separate study Monday suggesting its regimen of hepatitis C drugs had similar effectiveness to a competing regimen from Roche Holding AG (RHHBY) of Switzerland.
In the Enhance study, patients took either Vytorin or simvastatin alone for two years. (Initially, patients took Zetia plus simvastatin as separate tablets but then took single-tablet Vytorin after it was approved by U.S. regulators in July 2004.) At conclusion, the study found that artery thickening had progressed by 0.0111 millimeters in those taking Vytorin, compared with an increased of 0.0058 millimeters for those on simvastatin alone.
money.cnn.com
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