Anyone take Vytorin or Zetia???
[xx(], apparently it doesnt work as good as the company touted it.
http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm
3rd UPDATE: Vytorin Fails To Benefit Artery Vs. Statin Drug
January 14, 2008: 03:13 PM EST
(Adds comments from cardiologist beginning in fifth paragraph and updates stock prices.)
By Peter Loftus
Of DOW JONES NEWSWIRES
An eagerly awaited study suggested Vytorin, the blockbuster cholesterol drug from Merck & Co. (MRK) and Schering-Plough Corp. (SGP), didn't provide any significant benefit versus a statin drug in slowing down clogging of the arteries of people with hereditary high cholesterol.
The 720-patient study, however, also found that rates of side effects were generally similar between those on Vytorin and those taking the statin drug simvastatin, which is available generically. Some investors had feared the study would show a safety problem with Vytorin and its component drug Zetia. Vytorin combines simvastatin and Zetia in a single tablet.
The so-called "Enhance" study also showed that Vytorin reduced levels of bad cholesterol to a greater degree than simvastatin alone.
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.
Merck, Whitehouse Station, N.J., markets simvastatin under the brand Zocor, but it's also sold by generic manufacturers in a version that costs less than Vytorin. Generic simvastatin costs roughly $1 per pill, compared with about $3 per Vytorin tablet, according to drugstore.com.
Previous studies have proven that Vytorin and Zetia can lower bad cholesterol. Lowering bad cholesterol is believed to help slow artery clogging and thus help ward off heart attacks and strokes. But no clinical trials have proven specifically that Vytorin and Zetia can accomplish this. The Enhance trial is the first to measure Vytorin's effect on plaque buildup in the arteries, a process known as atherosclerosis.
Vytorin competes with Pfizer Inc.'s (PFE) Lipitor and AstraZeneca PLC's (AZN) Crestor in the cholesterol-drug market. Pfizer on Monday released a study suggesting new Lipitor users without cardiovascular disease had a lower risk of having a heart attack or other heart-related events versus those taking simvastatin, based on an analysis of a health-insurance claims database.
Results of the Enhance study could threaten sales of Vytorin and Zetia because the data suggest adding Zetia to simvastatin provides no significant benefit in slowing artery thickening, despite lowering bad cholesterol to a greater degree than simvastatin alone. Combined Vytorin and Zetia sales were about $3.7 billion for the nine months ended Sept. 30, up 33% from the year-earlier period.
The study failed to meet its primary goal, which was to show whether Vytorin was more effective than simvastatin alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. The study used imaging tests to measure artery thickness.
Merck spokesman Skip Irvine cautioned that the Enhance study was in a small, unique patient population: people with heterozygous familial hypercholesterolemia. This is a rare genetic disease in which people have severely high levels of low-density lipoprotein cholesterol, or LDL - the "bad" kind of cholesterol. It affects about 1 in 500 people, or 0.2% of the population.
Vytorin also is approved to treat non-hereditary high cholesterol - a broader population and one that wasn't part of the Enhance study.
Nissen, however, said the Enhance study population was the one "you'd most expect the drug to work in." He added: "If it doesn't work in this population it's not going to work in anyone" in slowing atherosclerosis.
Roger Blumenthal, a cardiologist and professor of medicine at Johns Hopkins in Baltimore, called the study "disappointing news," and suggested that some doctors might not prescribe Vytorin as early in the treatment process as they might have before.
But Blumenthal also said the study probably won't significantly affect prescribing patterns for the majority of doctors who were relatively conservative about prescribing Vytorin. "For the vast majority of people, it really won't change things," he said.
A more important test of Vytorin will come from three large "outcomes" studies of the drug, Blumenthal said. One study, titled "Improve-It," is measuring Vytorin's effect on heart attacks, strokes and cardiovascular deaths, but results aren't due out until 2011.
As for safety issues, the Enhance results may come as a relief to those who feared the study would show that Zetia and Vytorin significantly increased the risk for side effects such as liver problems. Merck and Schering-Plough said the rates of adverse events were generally similar between the Vytorin and simvastatin groups and generally consistent with each drug's existing product label.
"This result reaffirms Vytorin's safety," Goldman Sachs analyst James Kelly wrote in a research note.
Fears of a negative safety signal were stoked by the apparent delay in releasing the results of the Enhance study. The trial was completed in 2006, and many people had expected the results to be released last year.
In November, Merck and Schering-Plough said analysis of the trial results had been time-consuming and that they would modify the primary goal of the study in order to accelerate release of the data. They later reversed that decision after criticism from scientists and politicians.
At the time, Merck and Schering-Plough said they didn't know the study's results and said they hoped to present the data at a medical conference in March. The companies said Monday that they have submitted an abstract of the study to the annual meeting of the American College of Cardiology, scheduled for late March.
Merck's and Schering-Plough's handling of the release of the Enhance data has attracted government scrutiny. In December, the House Committee on Energy and Commerce said it was investigating "the withholding of clinical trial data." The committee requested documents related to the study and sought interviews with trial investigators and company employees.
The marketing for Vytorin has been heavy on colorful television ads directed at consumers. "There are two sources of cholesterol: food and family," they say, emphasizing that Vytorin goes after both dietary absorption of cholesterol and cholesterol the body makes naturally. In 2005, some $155 million was spent on direct-to-consumer advertising for Vytorin, the third biggest amount for a drug behind AstraZeneca Nexium and Sepcracor Inc.'s (SEPR) Lunesta, according to a 2007 study in The New England Journal of Medicine.
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.
The incidence of adverse events was generally similar, the companies said. Some 2.8% of those Vytorin had elevated serum transaminases - a potential sign of liver disease - versus 2.2% in the simvastatin group.
The Vytorin group had an average reduction in LDL cholesterol of 58%, versus 41% in the simvastatin group.
The data have yet to undergo the peer-review process of a medical journal or medical conference.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
(END) Dow Jones Newswires
01-14-08 1513ET
Copyright (c) 2008 Dow Jones & Company, Inc.
http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm
3rd UPDATE: Vytorin Fails To Benefit Artery Vs. Statin Drug
January 14, 2008: 03:13 PM EST
(Adds comments from cardiologist beginning in fifth paragraph and updates stock prices.)
By Peter Loftus
Of DOW JONES NEWSWIRES
An eagerly awaited study suggested Vytorin, the blockbuster cholesterol drug from Merck & Co. (MRK) and Schering-Plough Corp. (SGP), didn't provide any significant benefit versus a statin drug in slowing down clogging of the arteries of people with hereditary high cholesterol.
The 720-patient study, however, also found that rates of side effects were generally similar between those on Vytorin and those taking the statin drug simvastatin, which is available generically. Some investors had feared the study would show a safety problem with Vytorin and its component drug Zetia. Vytorin combines simvastatin and Zetia in a single tablet.
The so-called "Enhance" study also showed that Vytorin reduced levels of bad cholesterol to a greater degree than simvastatin alone.
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.
Merck, Whitehouse Station, N.J., markets simvastatin under the brand Zocor, but it's also sold by generic manufacturers in a version that costs less than Vytorin. Generic simvastatin costs roughly $1 per pill, compared with about $3 per Vytorin tablet, according to drugstore.com.
Previous studies have proven that Vytorin and Zetia can lower bad cholesterol. Lowering bad cholesterol is believed to help slow artery clogging and thus help ward off heart attacks and strokes. But no clinical trials have proven specifically that Vytorin and Zetia can accomplish this. The Enhance trial is the first to measure Vytorin's effect on plaque buildup in the arteries, a process known as atherosclerosis.
Vytorin competes with Pfizer Inc.'s (PFE) Lipitor and AstraZeneca PLC's (AZN) Crestor in the cholesterol-drug market. Pfizer on Monday released a study suggesting new Lipitor users without cardiovascular disease had a lower risk of having a heart attack or other heart-related events versus those taking simvastatin, based on an analysis of a health-insurance claims database.
Results of the Enhance study could threaten sales of Vytorin and Zetia because the data suggest adding Zetia to simvastatin provides no significant benefit in slowing artery thickening, despite lowering bad cholesterol to a greater degree than simvastatin alone. Combined Vytorin and Zetia sales were about $3.7 billion for the nine months ended Sept. 30, up 33% from the year-earlier period.
The study failed to meet its primary goal, which was to show whether Vytorin was more effective than simvastatin alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. The study used imaging tests to measure artery thickness.
Merck spokesman Skip Irvine cautioned that the Enhance study was in a small, unique patient population: people with heterozygous familial hypercholesterolemia. This is a rare genetic disease in which people have severely high levels of low-density lipoprotein cholesterol, or LDL - the "bad" kind of cholesterol. It affects about 1 in 500 people, or 0.2% of the population.
Vytorin also is approved to treat non-hereditary high cholesterol - a broader population and one that wasn't part of the Enhance study.
Nissen, however, said the Enhance study population was the one "you'd most expect the drug to work in." He added: "If it doesn't work in this population it's not going to work in anyone" in slowing atherosclerosis.
Roger Blumenthal, a cardiologist and professor of medicine at Johns Hopkins in Baltimore, called the study "disappointing news," and suggested that some doctors might not prescribe Vytorin as early in the treatment process as they might have before.
But Blumenthal also said the study probably won't significantly affect prescribing patterns for the majority of doctors who were relatively conservative about prescribing Vytorin. "For the vast majority of people, it really won't change things," he said.
A more important test of Vytorin will come from three large "outcomes" studies of the drug, Blumenthal said. One study, titled "Improve-It," is measuring Vytorin's effect on heart attacks, strokes and cardiovascular deaths, but results aren't due out until 2011.
As for safety issues, the Enhance results may come as a relief to those who feared the study would show that Zetia and Vytorin significantly increased the risk for side effects such as liver problems. Merck and Schering-Plough said the rates of adverse events were generally similar between the Vytorin and simvastatin groups and generally consistent with each drug's existing product label.
"This result reaffirms Vytorin's safety," Goldman Sachs analyst James Kelly wrote in a research note.
Fears of a negative safety signal were stoked by the apparent delay in releasing the results of the Enhance study. The trial was completed in 2006, and many people had expected the results to be released last year.
In November, Merck and Schering-Plough said analysis of the trial results had been time-consuming and that they would modify the primary goal of the study in order to accelerate release of the data. They later reversed that decision after criticism from scientists and politicians.
At the time, Merck and Schering-Plough said they didn't know the study's results and said they hoped to present the data at a medical conference in March. The companies said Monday that they have submitted an abstract of the study to the annual meeting of the American College of Cardiology, scheduled for late March.
Merck's and Schering-Plough's handling of the release of the Enhance data has attracted government scrutiny. In December, the House Committee on Energy and Commerce said it was investigating "the withholding of clinical trial data." The committee requested documents related to the study and sought interviews with trial investigators and company employees.
The marketing for Vytorin has been heavy on colorful television ads directed at consumers. "There are two sources of cholesterol: food and family," they say, emphasizing that Vytorin goes after both dietary absorption of cholesterol and cholesterol the body makes naturally. In 2005, some $155 million was spent on direct-to-consumer advertising for Vytorin, the third biggest amount for a drug behind AstraZeneca Nexium and Sepcracor Inc.'s (SEPR) Lunesta, according to a 2007 study in The New England Journal of Medicine.
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.
The incidence of adverse events was generally similar, the companies said. Some 2.8% of those Vytorin had elevated serum transaminases - a potential sign of liver disease - versus 2.2% in the simvastatin group.
The Vytorin group had an average reduction in LDL cholesterol of 58%, versus 41% in the simvastatin group.
The data have yet to undergo the peer-review process of a medical journal or medical conference.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
(END) Dow Jones Newswires
01-14-08 1513ET
Copyright (c) 2008 Dow Jones & Company, Inc.
0
Please sign in to leave a comment.
Comments
0 comments