ORLANDO, Florida (Reuters) - The good news for Merck & Co’s Zetia cholesterol fighter is that doctors do not seem unduly concerned about its latest setback in a clinical trial. The bad news is they think patient anxiety will cause its sales to drop anyway.
Physicians interviewed after release of data from a small study in which Abbott Laboratories’ Niaspan appeared to be safer and more effective than Zetia, see more use of Niaspan and other long-acting niacins to boost good HDL cholesterol. And they feel more than ever that Zetia’s clinical value must still be proven even though it slashes levels of bad LDL cholesterol.
“I don’t think Zetia suffered a body blow today, but it was a cautionary warning. It will give doctors and patients a lot of temporary heartburn,” said Dr. Richard Walsh, of the University Hospitals of Cleveland, immediately after the data was formally presented at the American Heart Association (AHA) scientific meeting in Orlando on Monday.
“It certainly suggests the use of niacin is equal to or better than use of Zetia,” said Walsh, who expects sales of Zetia and a related cholesterol drug Vytorin to continue declining due to intense media coverage of a third study that has led to questions about its clinical value.
“I think so, because unfortunately we live in a life of sound bites,” he said.
Merck shares were up 2.4 percent after analysts played down the importance of the data and said editorials in the New England Journal of Medicine citing limitations of the study would help mute any negative impact.
But doctors said the profile of niacin had been raised as they await a new wave of patient concern over Zetia.
“Real outcomes studies are needed still for Zetia, but these results certainly strengthen the argument that niacin should be used more widely and underscore the fact that Zetia continues to be of uncertain clinical benefit,” said Dr. Nathaniel Reichek, director of cardiac imaging at St Francis Hospital, a prominent heart hospital on Long Island in New York.
“I think it’s unfortunate that studies that are not definitive actually receive as much attention as they do because it ends up causing immense anxiety and confusion that can be allayed only by really powerful, large scale studies that give really hard answers,” he added.
Merck is currently conducting a large study called Improve-It designed to determine whether Zetia can help prevent heart attacks, strokes and death, but those results may still be years away. Meanwhile patient anxiety over the latest trial has begun.
Dr. Paul Armstrong of the University of Alberta in Edmonton, a member of the AHA panel that discussed the new data before an audience of more than 7,000, said he received an email from a patient early Monday morning asking if she should stop taking Zetia even though it was having the intended effect on her LDL levels.
“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,” said Kopecky in a telephone interview.
“If Improve-It 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.
Reporting by Bill Berkrot and Ransdell Pierson; Editing by Tim Dobbyn
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