The drug Vytorin, used to reduce LDL (bad) cholesterol in people at risk of heart disease, does not provide any clinical benefit according to the results of the ENHANCE study - a large, multi-year investigation whose results were recently published in the New England Journal of Medicine.

Researchers found that the drug, which is a combination of two other medicines, lowered bad choleserol, but did not lower the long term risk/effects of heart disease. Those taking Vytorin had the same rate of heart disease progression and showed the same number of related complications as those not taking Vytorin.

The findings have already ignited strong debate within the medical and research communities. Many doctors are urging a return to time tested medicines, like statins, that have proved their effectiveness with many clinical trials. Researchers, on the other hand, are asking questions that may be fundamental to the issue as a whole. Namely, is it the drug that failed, or should we re-evaluate what we know about the links between various heart disease risk factors and actual clinical disease?

Researchers highlight the idea that Vytorin does lower LDL, and is actually more effective at this task than older drugs. Even with this, though, the drug did not produce the diminishing of artery plaque size associated with reduction in real heart risk. The question is then, do we really have a firm understanding of how LDL and real heart risk are related?

On the consumer protection front, some are asking questions about the business practices of large drug companies, and again questioning the rationale of direct-to-consumer drug advertising. Vytorin, which is heavily marketed in the US (at a cost of more than $200 million) has logged over $5 billion worth of sales here, but sales in Canada, where similar advertising is prohibited, are 400% lower. Merck, which manufactures Vytorin, is already the subject of Congressional inquiries about why it has taken so long for these contrary results to come to light, when the drug has been on the market for more than five years and has charted billions of dollars worth of sales.

Patients with high blood pressure are at increased risk of arterial plaque build up and heart attack because of the damage that increased pressure causes to the walls of blood vessels.

Read More:
Media Coverage of the Vytorin Debate
ENHANCE Study from the New England Journal of Medicine
Response to ENHANCE Study That Questions our Real Understanding of Heart Risk