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Vytorin: Yet Another Cholesterol Drug

Posted by medconsumers on February 1, 2006

Vytorin Ads Aimed at Keeping Profits High

“Pay no attention to direct-to-consumer ads for prescription drugs. These are meant to sell drugs, not educate consumers, and they only add to the prices you pay.” Even if you follow this wise advice offered by Marcia Angell, MD, in her acclaimed 2004 book, The Truth About Drug Companies, chances are you will have one of the following drugs prescribed by a physician. They are currently advertised heavily to doctors as well as the general public. Not surprisingly, the most aggressively promoted drugs wind up to be the most frequently prescribed…and the most frequently given out as free samples. In many cases, there are lower cost alternatives.

Vytorin to Lower Cholesterol

When a blockbuster drug is due to lose its patent protection—and blockbuster is usually defined as sales over a billion dollars a year—the drug company must find creative ways to keep the profits high. Vytorin illustrates one path commonly taken by drug companies. This drug is the creation of the pharmaceutical giant Merck, which will soon face competition from cost-cutting generic drug companies when its blockbuster cholesterol-lowering drug, Zocor, goes off patent this year.

Working with another drug company, Schering-Plough, Merck has come up with Vytorin.  Sometimes referred to as the newest statin, the top-selling class of cholesterol-lowering drugs in the world, Vytorin combines an older statin, Zocor (generic name: simvastatin), with a newer cholesterol-blocking drug called Zetia, made by Schering-Plough. To allow plenty of time to sell doctors the idea that they should prescribe a newer, more expensive drug, Vytorin came on the market in 2004—well before Zocor’s patent runs out. Its sales have risen steadily ever since.

How Long Did the Vytorin Studies Last?

People are usually on cholesterol therapy for life; yet the two FDA-required clinical trials lasted only 12 and 23 weeks, respectively. In both trials, participants were randomly assigned to take either Vytorin, a placebo (sugar pill), Zocor, or Zetia. The study participants taking Vytorin showed greater reductions in the so-called “bad cholesterol,” or low-density lipoproteins. Whether Vytorin is better than any other single-ingredient statin drug at reducing the risk of a heart attack or stroke has not been studied.

Cautions:

Statins are great at lowering cholesterol; but they are much less impressive at lowering the risk of heart attack and stroke in people without heart disease. Media reports usually refer to statins as safe or well tolerated. Rarely is it mentioned that virtually all the clinical trials involving statins were conducted by the drug’s manufacturer. And many of these drug trials have failed to release all the data involving adverse reactions. [See the review of primary prevention trials http://www.ti.ubc.ca, Letter #48.] Therefore, the safety of long-term statin use remains unknown. Even less is known about the safety of the other drug in Vytorin, called Zetia, which works by partially blocking the absorption of cholesterol in the small intestine. Zetia was approved by the FDA in 2002 based on its cholesterol-lowering ability, shown in two trials that lasted only two and eight weeks, respectively.

Alternatives:

Two statins, Zocor and Pravachol, will become available generically this year, and only one, lovastatin (brand name: Mevacor), is already available generically for $1.00 to $1.88 a day, compared with $4.00 a day for the top-selling statin, Lipitor. If you are taking an expensive statin, ask your doctor whether you can switch to generic lovastatin. No long-term head-to-head comparison trial of all six statin drugs has been conducted to determine whether Lipitor is superior to the others in reducing the risk of heart attack or stroke.

Maryann Napoli, Center for Medical Consumers ©
February 2006

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