A panel of the Food and Drug Administration said that the cholesterol-lowering drug Crestor ought to be offered to more people because it could help save lives and prevent heart attacks and strokes even among people who don’t have high cholesterol.
That recommendation is based on the findings of a study funded by drugmaker AstraZeneca involving almost 18,000 people, which found that patients with normal or slightly elevated cholesterol and high levels of C-reactive protein could benefit from taking the drug. C-reactive protein is a marker of inflammation in the body, which could indicate an increased risk of heart disease.
What the study showed
The study found that, among those patients who got the pill instead of a placebo, there was a 44 percent reduction in adverse incidents including death, heart attack and stroke. The research showed a 20 percent reduction in deaths from heart attacks among those who took the pill.
The drug company wants the FDA to approve marketing the drug to a much wider segment of the population. An estimated six million people would fall into the category of having normal cholesterol levels but high C-reactive protein measures. The drug, one of the most expensive in the category of statin drugs on the market — already reached $3.6 billion in sales last year. It’s thought adding these new patients would boost sales by about $500 million a year.
Crestor caveats
The FDA noted, however, that the increase in the number of study participants on the drug who developed diabetes was statistically significant, and 13 people in the study died from gastrointestinal ailments while on the drug. In addition, 18 patients reported being in a confused state while on the drug, compared to four taking the placebo, but it wasn’t thought that was connected to the drug.
Another potential problem with giving people with high C-reactive protein levels but healthy cholesterol a cholesterol-lowering drug is that C-reactive protein is a general measure of inflammation in the body, not a specific measure of heart disease risk. Inflammation could be caused by a host of other health problems. It’s not now a commonly used test, either, but that’s likely to change if the FDA goes ahead with the panel’s recommendation.
(By Sarah E. White for CalorieLab Calorie Counter News)
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Panel says cholesterol drug could help more people