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By Herb Newborg

Merck's Muti Billion Dollar Drug Does Not Work
Study concludes blockbuster drug does not reduce clogged arteries.

Despite no evidence that Zetia’s cholesterol-lowering ability actually reduces the incidence of heart attack or stroke in patients who take the medication, it was approved by the US FDA in 2002. Zetia annual sales have topped out at over $ 5 billion.

A new study released on Sunday found that the drug DOES NOT reduce clogged arteries, the primary argument for artificially lowering cholesterol.



The new study showed Zetia was inferior to nutritional supplement Niacin which is inexpensive and available without a prescription, at clearing clogged arteries. But the study didn't show that Zetia worsened artery-clogging, on average, which some Merck investors had feared as a worst-case scenario.

The new study, titled "Arbiter 6," is the latest setback for Merck's blockbuster cholesterol-drug franchise, whose sales have fallen since early 2008 on separate studies that raised questions about the efficacy and safety of Zetia and Vytorin.

The study looked at patients who had already lowered their LDL cholesterol to the recommended level by taking a statin. Patients given Niacin had reductions in artery wall thickness, while those on Zetia had no change. Doctorss view artery thickness as a way of predicting heart attack and stroke risks. There were nine heart attacks among Zetia patients but just two in the Niaspan group.

Researchers enrolled 363 people with heart disease or a high risk for it who had been taking statins for six years on average, but it was stopped in June because one group was faring much better than the other. “Niacin is the clear winner and led to very clear reductions in the amount of atherosclerosis that patients had,” Allen Taylor, the lead investigator told Reuters while at the American Heart Association scientific meeting in Orlando, Florida.

Last year, a large study found that the combo pill Vytorin, which combimes Zocor and Zetia, was no more effective than Zocor alone, a statin now available as a cheap generic. In August, Merck and Schering-Plough agreed to pay $41.5 million to settle lawsuits claiming they delayed unfavorable study results on the drugs because they would hurt sales.

Vytorin had nearly $2 billion in sales in the United States in 2008.

Doctors do not seem unduly concerned about this latest setback, a clinical trial showing that the drug DOES NOT WORK or the increase in adverse heart events noted by one doctor. Reuters reports:

"I think Zetia sales will continue downward because physicians are not seeing anything positive from these trials," said Julie Johnson, chair of pharmacotherapy at the University of Florida.

"This new trial probably slightly diminishes the confidence of its role in terms of long-term effectiveness," she said.

Dr. Stephen Kopecky, professor of medicine and cardiovascular disease at the prestigious Mayo Clinic in Rochester, Minnesota, found data showing more serious adverse heart events with Zetia -- 9 vs 2 -- to be particularly worrisome, despite the small numbers. "It will push us more toward giving Niaspan (a Niacin based drug)," said Kopecky in a telephone interview.

"If Improve-It (a separate clinical trial funded by Merck) shows a big, big difference in mortality and major events with ezetimibe (Zetia) being better, then we would switch back," he said.

But given the new data, if patients are in need of additional cholesterol medicine on top of widely used and proven effective statins, his first choice "would clearly be a Niaspan type product."

Kopecky was not inclined to take patients off of Zetia, but if they show any real concern he would not hesitate to change their medication.

"I have a very low threshold for switching them off ezetimibe now," he said.