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Advisory panel votes on Crestor as heart attack prevention

Jenny Decker RN's picture

In what has been called a significant vote, an advisory panel for the FDA voted to approve AstraZeneca's Crestor as a preventive for heart attack. It important to understand that these panels only make recommendations to the FDA. The FDA does not always do what the advisory panels suggest. However, it almost always does. Crestor is categorized as a statin, which is a group of drugs that work to lower cholesterol in the body. The advisory panel voted as a response to AstraZeneca's bid to prevent heart attack in healthy people. This bid is a result of the study on Crestor called JUPITER.

The JUPITER study showed compelling evidence of the ability of Crestor, or rosuvastatin, to decrease the incidence of heart attack, stroke, the need for surgery that opens clogged arteries, and even preventing death from heart attack. In the study, it was shown that even deaths from both heart attack and stroke were prevented.

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The study was only focused on the effects of the specific drug, Crestor. It is not clear whether other statins have the same effect. There is need for more study in this area, especially the concerning the fact that Lipitor will be available as a generic medicine in about 18 months, writes ABC news. Lipitor is another statin, has high potency, and may have the same effects as Crestor, but only study will be able to answer the question as to whether all statins have the ability to prevent heart attack.

As with any drug, there are concerns as well benefits. Crestor is no different. Reuter's writes that along with new suggestions and guidelines for use of Crestor that physicians will use the drug too broadly in patients that are at lower risk and may not actually need the drug. However, AstraZeneca has made it clear that it's goal is not to treat those at very low risk. It remains to be seen whether prevention with statins could possibly pull heart attack down from the leading cause of death in the United States.

Another concern with Crestor is that it increases the risk of developing diabetes mellitus by 27 percent. This is a very high number considering that diabetes mellitus is on the rise worldwide. In turn, diabetes is linked closely with heart disease. It may be possible that Crestor could increase the chances of heart disease with the increased chance of developing diabetes mellitus. With information from the JUPITER study however, the advisory panel felt that the benefit of Crestor in preventing heart attack and possibly death outweighs the risk of the diabetes.

Global sales of Crestor are already $3.6 billion. The 2010 consensus forecast shows sales to reach $6.75 billion and in 2013 that number will rise to $6.75 billion. With the release of the JUPITER study last November, Crestor has boosted sales for AstraZeneca. This forecast is certainly positive, but it has been overshadowed by generic manufacturers challenging the drug. Release of a generic formula is possible for 2016 unless a case goes to trial in February of 2010. Even with the potential trial, Crestor has been a major driver for AstraZeneca. If the FDA approves it for prevention of heart attack in healthy people, an additional 6.5 million Americans will meet criteria from the JUPITER study.