How can a drug’s study results involving just over 200 or so participants shake up healthcare policy? If the name of that drug is Zetia, there’s already enough political baggage that is making that happen. Statements like the following from the study’s lead investigator are pretty definitive — and to Merck, pretty damning:

“The results are very clear,” says lead investigator Allen Taylor of the Medstar Research Institute. “Niacin was superior.”

You read right. Niacin, a commonly used (and cheap) B vitamin did a significantly better job of shrinking artery plaque than the billion-dollar blockbuster ezetimibe (Zetia), also a component in the top-selling agent, Vytorin. Critics may claim — and rightly so — that this trial, involving just 208 people — is just too small to have a significant impact on clinicians who prescribe Zetia and/or Vytorin to treat this country’s number one killer — heart disease. However, there is no denying that the impact beyond this result is huge and is based upon the fact that ezetimibe’s lackluster trial data was the third iteration in two years^[1] to challenge the effectiveness of one of the world’s most popular heart drugs, with $21B in sales since it was introduced in 2003.

The result was so pronounced that the study was stopped in 14 months. Although the use of ezetimibe, an expensive branded drug not automatically covered on all drug plans, was not found to be superior to the much, much insanely cheaper niacin, it does represent a niche for doctors treating patients who have yet to reach cholesterol goals and who cannot tolerate some of the more bothersome adverse effects^[2] of niacin. Of course, Merck “stands by” Zetia, but they have to be preparing themselves for the inevitable onslaught of patient concern of paying in a major way for a drug found to be no better than a lowly B vitamin in the treatment and secondary prevention of heart disease. | LINK

1. Last year, the ENHANCE trial showed Vytorin, made of ezetimibe (Zetia) and simvastatin (Zocor), did no better job of treating clogged arteries than simvastatin alone. [↩]
2. These include diarrhea; dry skin; headache; itching; stomach upset; temporary skin redness, tingling or feelings of warmth and flushing. [↩]

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