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FDA Approves New Use for Crestor

New indication for people 50 and older

By James Limbach
ConsumerAffairs.com

February 9, 2010

The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

This applies mainly to 50 years of age and older and women 60 and older who have an elevated amount of a substance known as high sensitivity C-reactive protein in their blood and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of HDL cholesterol, the so-called "good cholesterol."

This new indication does not support the use of Crestor in those who have an elevated high sensitivity C-reactive protein but no traditional cardiovascular risk factors.

Crestor is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. High amounts of LDL cholesterol, the so-called "bad cholesterol," is a known risk factor for heart attacks, strokes, and heart disease.

"This expanded indication for Crestor will provide health care providers with a new therapeutic option to help appropriately-identified people lower their risk for a cardiac event," said Eric Colman M.D., deputy director, Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.

The new application is based on results from a study called the JUPITER trial, which compared 8,901 patients who received Crestor for two years with the same number of patients who received a placebo.

Those who took Crestor had fewer heart attacks, strokes and other so-called cardiac events, and underwent fewer procedures such as coronary angioplasty or coronary artery bypass surgery to treat or revascularize their arteries.

High sensitivity C-reactive protein is a nonspecific indicator of inflammation, which is associated with the buildup of cholesterol and other fatty material in the coronary arteries.

Crestor is already approved for use in combination with diet and exercise to lower LDL cholesterol and a related substance known as triglycerides in patients with a high amount of these substances in their blood.

The medication is also approved to slow the progression of atherosclerosis -- a thickening of the artery wall due to the buildup of cholesterol and other fatty materials.

Although Crestor is widely used, the drug is not without its problems.

Michele of Saint Petersburg, FL, tells ConsumerAffairs.com that she was told side effects with Crestor are rare, but "I began experiencing side effect symptoms (muscle weakness, stomach pain and more). The proper CPK level blood test was taken and discovered I had Rhabdomyolysis (skeletal muscle breakdown). I missed a week's worth of work and paid for many doctor visits, CAT Scans and Ultra Sounds which were unlikely necessary if CPK level had been tested first."

Wayne of Seffner, FL, wrote us, "My doctor has prescribed about every statin product from Crestor to Vitorin and I strongly recommend everyone avoid them all. Change your diet. I had such severe muscle problems and pain my doctor took me off all of them. That was six months ago and I am still on muscle relaxers just to maintain a normal lifestyle. The muscle damage is still a problem and I will never take a statin again."

In fact, questions have been raided about Crestor's safety since the drug was introduced in 2003.

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