Study: Combo Cholesterol Drug No Better than Generic
An AP story recently reported a clinical trial has shown that the combination cholesterol drug Vytorin is no more effective than a high dose of one of its components available generically. This information was released by Vytorin's makers Monday, January 14, 2008.
Vytorin, developed by Merck & Co. and Schering-Plough Corp., is a combination of Zetia and Merck's Zocor, which lost patent protection in 2006. Merck and Schering-Plough market Zetia and Vytorin jointly and split the profits. In the quarter ended September 30, sales of Zetia and Vytorin hit $1.3 billion, up 26 percent from the year-ago period.
The study measured the amount of artery-clogging plaque in three areas in a group of 720 patients with a rare condition heterozygous familial hypercholesterolemia, predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of generic Zocor, known as simvastatin.
The condition affects less than 1 percent of the population.
In December, a congressional committee requested more information on the study. The results were delayed, the companies maintained, because of the complexity of the data. Merck and Schering-Plough are conducting three additional studies, involving more than 20,000 high-risk patients.
Results raised several questions about Vytorin's effectiveness, which will likely go unanswered until the company presents the data at the annual American College of Cardiology meeting in March.
Questions include:
The possibly too short duration of the study in comparision to the time needed to develop plaque in the arteries;
Does this effect apply to the patients who do not have heterozygous familial hypercholesterolemia;
Does the effect change the preventative effect of lipid lowering agents (careful to analyze absolute improvement vs relative improvement) in the development of CV diseases; and
No harm was seen – no difference was noted in plaque formation thereby questioning the efficacy of adding Zetia to Zocor – and no more or new morbidities or mortalities were uncovered.
Vytorin, developed by Merck & Co. and Schering-Plough Corp., is a combination of Zetia and Merck's Zocor, which lost patent protection in 2006. Merck and Schering-Plough market Zetia and Vytorin jointly and split the profits. In the quarter ended September 30, sales of Zetia and Vytorin hit $1.3 billion, up 26 percent from the year-ago period.
The study measured the amount of artery-clogging plaque in three areas in a group of 720 patients with a rare condition heterozygous familial hypercholesterolemia, predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of generic Zocor, known as simvastatin.
The condition affects less than 1 percent of the population.
In December, a congressional committee requested more information on the study. The results were delayed, the companies maintained, because of the complexity of the data. Merck and Schering-Plough are conducting three additional studies, involving more than 20,000 high-risk patients.
Results raised several questions about Vytorin's effectiveness, which will likely go unanswered until the company presents the data at the annual American College of Cardiology meeting in March.
Questions include:
The possibly too short duration of the study in comparision to the time needed to develop plaque in the arteries;
Does this effect apply to the patients who do not have heterozygous familial hypercholesterolemia;
Does the effect change the preventative effect of lipid lowering agents (careful to analyze absolute improvement vs relative improvement) in the development of CV diseases; and
No harm was seen – no difference was noted in plaque formation thereby questioning the efficacy of adding Zetia to Zocor – and no more or new morbidities or mortalities were uncovered.
Labels: In the News
posted by George W. Shannon, MD at
12:44 PM
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