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IS THERE A NEW CHOLESTEROL DRUG
ON THE HORIZON?

Merck has been testing a new drug to help lower cholesterol. It's called Cordaptive, and its active ingredient is niacin (vitamin B3). Until now, niacin has been available without a prescription from pharmacies and health food stores. Doctors routinely recommend it for patients with a high cholesterol level because it has been shown to lower the levels of both total cholesterol and low-density lipoprotein (LDL), or “bad cholesterol.” However, Cordaptive also contains the experimental new drug laropiprant, which was supposedly added to reduce the redness and warming of the face and neck that are often caused by niacin. 

Cordaptive has not yet been approved by the US Food and Drug Administration (FDA), but that approval will probably be granted soon. Is this good news or not? Merck has been losing sales because that company’s trade-name anticholesterol drug, Zocor, has experienced significantly lower sales since its generic version (simvastatin) was introduced in 2006. If Cordaptive is successful, it can help bolster those sagging sales figures. 

If you agree that a drug like Cordaptive will benefit your health, you must first believe that even a mildly elevated cholesterol level can lead to a medical problem such as heart disease. Although it is true that patients with a heart problem often have elevated cholesterol levels, it is not perfectly clear that a high level of cholesterol causes heart disease. The presumed cause-and-effect relationship between high cholesterol and cardiovascular disease is widely held, so it seems reasonable to find drugs that will lower cholesterol levels. Merck and other pharmaceutical manufacturers are ever on the lookout for drugs they can patent. It makes good business sense for Merck to identify and market such a drug. Does it make other sense? 

I'm concerned about the addition of laropiprant to Cordaptive. The articles I've read indicate that laropiprant is an experimental drug. Its only use in Cordaptive is to reduce the flushing (redness, burning, and tingling of the face) that might be caused by the dose of niacin. You are thus using one drug (an experimental agent in this case) to counteract the effects of another drug (niacin). Although that might be a logical approach, is it good medicine?  

The concept of using a medication to treat the adverse effects caused by another medication is fairly common these days, though I recall a time in the past when that would have been seriously frowned upon. I also recall numerous approved over-the-counter products (such as the cold medication Dimetapp) that were removed from the US market because they contained combinations of drugs, one of which was eventually proven to adversely affect health. Although I think that permitting a rational mixture of drugs in a single product is a better plan than banning drug combinations altogether, I'm a bit confused about the FDA’s focus on the matter of drug combinations. It seems like the rules are changing during the game.  

Why is it necessary to introduce another version of niacin? There is a slow-release version of niacin (Niaspan, made by Abbott Laboratories) that is already on the market. When asked about the "problem" of flushing that can be caused by niacin, a spokesperson from Abbott reportedly said that facial flushing is usually a temporary effect that can be easily managed with aspirin. The question of whether laropiprant is safer than aspirin then arises. Nobody has an answer for that one — yet. I wonder, though, how long it will take — after FDA approval — before we notice some problems with Cordaptive.  

I don't have the confidence in drug manufacturers that I had when I started in this field back in the 1960s. It seems that more and more drugs hit the market and then are discovered to be harmful. If I was prescribing drugs and I decided that niacin would be needed to lower someone's cholesterol levels, I’m sure that I wouldn't be prescribing Cordaptive for many years. My dad told me never to buy a new-model car until it had been on the road for a few years. Let them work out the kinks on the other guy, not me! I think that advice applies to using prescription drugs as well. 

You hear it all the time: "Ask your doctor if OUR DRUG is right for you." If my doctor were to prescribe Cordaptive for me, I'd promptly ask, "Is this really necessary for me?" 

You may also be interested in our article from 2006, STATIN DRUGS CAN KILL YOU

    

Simvastatin is a hypolipidemic drug belonging to the class of pharmaceuticals called "statins". It is used to control hypercholesterolemia (elevated cholesterol levels) and to prevent cardiovascular disease. RETURN