Zetia now available as the generic ezetimibe first became available in 2002 as a cholesterol lowering drug. With its quite unique mechanism of action, Zetia reduces absorption of cholesterol from the small intestine. The more popular statin family including Zocor, Lipitor, Pravachol and Crestor works within the liver cell to halt cholesterol production.
Given its distinct activity, combinations of Zetia with a statin remain popular. As an example Vytorin combines Zetia with Zocor also known as simvastatin.
A large trial was conducted years after the drug received marketing approval. Surprisingly it demonstrated Zetia failed to provide any additional benefits when compared against simvastatin alone. It did not decrease the incidence of heart attacks or stroke and may have been associated with increased formation of cholesterol laden arterial plaque.
Even under intense pressure from the medical community, the drug company delayed publication of this information from their own sponsored study as long as possible. After release they feared their $4 billion franchise would tumble. Indeed it did. Especially when other studies confirmed the lack of benefit of Zetia in protecting against heart disease, stroke and cancer.
In 2015 another study was published. It also was funded by the company and is referred to as IMRROVE-IT. Involving 18,000 participants in 39 countries and 1147 different sites they once again tested Zetia alone or in combination with simvastatin among people within 10 days of a cardiac event.
Although heart disease remains the major cause of death in the United States, sponsors of the study conducted it not only here but also in Turkey, Ukraine, Slovakia, Malaysia, India, Ecuador, Colombia, Brazil, Estonia and Hungary among others. Such diverse patient locations create major problems for standardization and oversight.
While the headline claims of a 24% reduction in LDL and a 35% relative reduction in combined cardiovascular events sounds impressive, let’s dig deeper. The outcomes revealed the absolute reduction in events was only 2% after 7 years and the benefits were delayed until after the first year.
Additionally there was not statistically significant improvement in all cause mortality, cardiovascular related death, death from coronary heart disease, fatal heart attack, hemorrhagic stroke, hospitalization for unstable chest pain or need for revascularization.
And by the way the drug did not seem to provide benefits to men, those less than age 75, non-caucasians, diabetics, current smokers or those with normal blood pressure.
If you seem a little skeptical about Zetia, join the crowd.
Негізгі бет Zetia
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