Harvard Women's Health Watch

In February 2010, the FDA approved rosuvastatin (Crestor), a cholesterol-lowering drug, for the prevention of heart disease in people with normal cholesterol levels. A report in the March 9, 2010, issue of Circulation helps to explain why this decision makes sense.

Crestor is one of several statins -- drugs that reduce cholesterol in the blood by inhibiting its production in the liver. Statins lower total cholesterol, LDL (bad) cholesterol, and triglycerides; slightly raise HDL (good) cholesterol; and reduce C-reactive protein (CRP), a marker of inflammation. Crestor and other statins have already been approved to slow the progression of cardiovascular disease and to reduce elevated cholesterol in healthy people. Crestor is now approved for men ages 50 and over and women ages 60 and over who have normal LDL cholesterol but elevated CRP levels (as measured by a high-sensitivity test called hs-CRP) and one additional cardiac risk factor, such as high blood pressure, low HDL cholesterol, or smoking. The FDA's decision acknowledges the drug's ability to dampen inflammation, which is increasingly implicated in cardiovascular disease.

In expanding the uses of Crestor, the agency cited evidence from JUPITER, a trial involving nearly 18,000 healthy women and men with elevated CRP levels but normal levels of LDL cholesterol. In that study, published in November 2008, volunteers who used Crestor for almost two years were 44% less likely to suffer a major cardiovascular event, such as heart attack or stroke, compared with those taking a placebo.

In the Circulation report, a team led by researchers from Boston's Brigham and Women's Hospital analyzed data from the 6,800 women in the JUPITER trial and combined it with comparable information about 6,300 women in five prevention studies of various other statin drugs. In women, unstable angina was the "major cardiovascular event" most often prevented by statin use; in men, it was stroke.

The FDA and the study's authors are careful to point out that for some women, the risks of taking statins may outweigh the benefits. In JUPITER, the drugs increased the risk of developing diabetes by almost 50 percent in healthy women (though they reduced the risk of a cardiovascular event by 40 percent in those who had prediabetes). Statin users also have a 2 percent risk of liver damage and a 5 percent risk of muscle pain. There is no evidence that statins benefit individuals with elevated CRP but no other cardiovascular risk factors.

Funding for the Circulation study came from several statin manufacturers, and the patent on the hs-CRP test is held by Brigham and Women's Hospital and one of the study investigators, Dr. Paul M. Ridker. Dr. Ridker was the principal investigator of the JUPITER trial.


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