Earlier this week, AstraZeneca's (AZN) widely used cholesterol-lowering drug Crestor was approved by the U.S. Food and Drug Administration for use in people with normal cholesterol to prevent heart attacks and strokes. The approval could lead to a much bigger market for Crestor, but has also led to a number of critics questioning the decision.Crestor, along with Pfizer's (PFE) Lipitor and Merck's (MRK) Zocor, or its generic version simvastatin, belongs to a class of drugs called statins that work by stopping an enzyme from making cholesterol. High levels of LDL cholesterol, the so-called "bad cholesterol," can lead to clogged arteries is a known risk factor for heart attacks, strokes, and heart disease. These medicines generated $33.8 billion in 2008 global sales, according to IMS Health, a health care research firm.

Until now, statins have been prescribed to reduce high levels of cholesterol, but now Crestor will be also prescribed to reduce the risk of heart attack in people with these risk factors:
  • Men age 50 and older or women age 60 and older
  • Elevated high-sensitivity C-reactive protein level (CRP) of more than 2 milligrams per liter
  • Another risk factor for cardiovascular disease, such as high blood pressure, low levels of "good cholesterol," smoking or a family history of early heart disease
FDA Approval is a Boon to AstraZeneca

No doubt, the FDA approval is a boon for AstraZeneca. Already, Crestor sales in 2009 amounted to $4.5 billion. The FDA had previously said that up to 6.5 million Americans meet the new criteria. At $4 a day, this can give a significant boost to Crestor sales. Also, since it is also not clear whether the results would be the same with other statins, this differentiation is important to AstraZeneca, especially in light of Lipitor losing its patent protection in 2011. Generic simvastatin can be had for $4 a month.

But while the potential market for Crestor is now much bigger, sales growth will depend on significant changes in doctor behavior to scan for CRP -- or C Reactive Protein -- which can, in high quantities, signal the presence of inflammation in the body, a problem linked to heart disease. Currently, few doctors test their patients for CRP. Also, not every person with high CRP levels should use Crestor, the FDA cautions, only those with other risk factors for heart disease.

The approval is based on clinical trials known as the "Jupiter " study of about 18,000 people and funded by AstraZeneca. The study shows that Crestor lowers the risk of heart attacks by 44%. And, the study results were so strong that it was stopped early.

Critics Point to Flaws in the Study

But not everybody agrees that Crestor should be used by more people. "The Jupiter study had several significant weaknesses in design," The Health Care Channel points out in an interview with Dr. Gordon Guyatt, a professor in the Department of Clinical Epidemiology & Biostatistics at the McMaster University in Ontario, Canada. For example, the data was skewed because the study was stopped early. Also, in his analysis of the unpublished data, Guyatt determined that there was no reduction in deaths caused by the heart related events.

The FDA also cautioned that more people receiving Crestor in the Jupiter study developed diabetes than those taking placebo. But MedPage Today adds that there were other risks associated with Crestor, including 13 deaths due to gastrointestinal disorders in the Crestor arm and 18 patients reported experiencing a "confused state" while taking the drug.

Heart disease caused 425,425 deaths in 2006 and is the single leading cause of death in America today, according to the American Heart Association. More than half of patients who suffer heart attacks or other cardiovascular problems have normal cholesterol levels.

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