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Cleveland Clinic plans head-to-head study to see which is better
By Tracy Wheeler
Beacon Journal
Published on Thursday, Jan 17, 2008
Lipitor and Crestor both claim to lower bad cholesterol, while boosting good cholesterol.
But which drug is better? More specifically, which one does a better job of stopping — or even reversing — plaque build-up in arteries and, ultimately, reducing heart attacks and strokes?
The Cleveland Clinic plans to answer those questions with an international head-to-head study of the two powerhouse drugs.
While other trials have examined the effectiveness of Lipitor and Crestor separately, ''it's difficult to compare different studies,'' said Dr. Stephen J. Nicholls, director of the intravascular ultrasound lab at the Cleveland Clinic. ''The ideal way to do this is a very large, direct, head-to-head comparison to see if one therapy has a direct result that's above and beyond the other.''
The SATURN trial — the full title is Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin — will enroll 1,300 patients at about 175 hospitals in 20 countries.
Results of the trial, which are not expected until 2011, will help doctors decide which drug is best for patients.
Both Lipitor (atorvastatin) and Crestor (rosuvastatin) work by blocking cholesterol production in the liver, thereby reducing the amount of cholesterol in the bloodstream.
Once in the blood, ''bad'' cholesterol — low-density lipoprotein, or LDL — forms plaque inside arteries in a process known as atherosclerosis. Over
time, this plaque can become dislodged, causing blockages that lead to heart attacks or strokes.
While both drugs have been shown to reduce bad cholesterol, they also increase the production of ''good'' cholesterol — high-density lipoprotein, or HDL — which sweep plaque out of the arteries and back to the liver for disposal.
The trial, Nicholls said, will monitor changes in patients' HDL, changes in patients' LDL, and how those changes affect plaque formation in those patients. Such information will provide ''much greater insight into how these therapies work,'' while answering the important question of ''what is the effect of these therapies on actual disease that causes heart attacks and strokes?''
The Cleveland Clinic's announcement comes just one day after Merck and Schering-Plough announced that their cholesterol-lowering drug Vytorin — which combines the cholesterol drug Zetia with the statin drug simvastatin — did no better job of reducing plaque build-up in arteries than simvastatin alone. In fact, patients taking Vytorin showed more plaque build-up than those taking simvastatin alone.
Considering that heart disease is the nation's No. 1 killer — taking the lives of 2,400 Americans a day, or one death every 37 seconds — the effectiveness of cholesterol drugs is not just an academic question.
And there's always an undeniable economic angle attached to such head-to-head trials. Lipitor is currently the top-selling statin, earning Pfizer $12.9 billion worldwide in 2006, compared to the $2 billion Crestor brought in for AstraZeneca. (Vytorin and Zetia earned about $5 billion each in 2007.)
The Cleveland Clinic undertook a similar head-to-head comparison that resulted in 2004's findings that Lipitor did a better job of preventing heart disease than Pravachol (pravastatin).
''When we analyzed the results . . . we realized that we had found an approach to coronary disease treatment that could literally stop heart disease in its tracks,'' Dr. Steven Nissen said at the time. ''The results were striking, demonstrating a complete halting of coronary disease progression in the atorvastatin-treated patients and continued progression of disease in the pravastatin-treated group.''
The SATURN trial will be funded by AstraZeneca, the maker of Crestor, though Nicholls pointed out that the Cleveland Clinic will design the study, conduct the trial and publish the data in full, whatever the results.
Tracy Wheeler can be reached at 330-996-3721 or tawheeler@thebeaconjournal.com.
Lipitor and Crestor both claim to lower bad cholesterol, while boosting good cholesterol.
Get the full article here.
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