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Why was the Niaspan vs. Zetia trial stopped?
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Yes, folks, we have another cholesterol-drug trial mystery on our hands. A study comparing Abbott's Niaspan drug with Merck/Schering-Plough's Zetia was terminated by an independent steering committee. All we know at this point is what's posted on the NIH clinical trial registry: It wasn't stopped for safety reasons, but based on results of a "pre-specified, blinded interim analysis." The trial's lead investigator wouldn't tell Dow Jones any more about the trial's halt, and the companies themselves said they didn't know.
Obviously someone knows, but for some reason those people aren't talking. Presumably some people at Abbott and Merck/Schering-Plough know, too--just not the PR staff that's talking to the press. And the results could be significant; if one or another of the drugs proved clearly superior, scrips could grow by 5 percent to 20 percent over the next year, analyst Jon LeCroy told the news service. Or shrink by that much, depending.
So here's the skinny on the stopped trial, known as ARBITER 6 HALTS. Begun in November 2006, it tracked 400 patients at risk for heart attacks who were already taking statin meds. One group got Niaspan added to its regimen; the other, Zetia. Each drug takes a different tack on cholesterol, with Niaspan boosting "good" cholesterol and Zetia primarily lowering the "bad" sort. Researchers then looked at artery thickness to see how each drug fared, using the same ultrasound technique that proved so troublesome in the now-infamous Enhance study that compared Zocor/simvastatin with Vytorin, the Merck/Schering-Plough combo drug that mixes Zocor with Zetia.
Some analysts are speculating that Niaspan was the study victor. "We think Niaspan likely performed better than Zetia in the HALTS study," Wells Fargo analyst Larry Biegelsen told Bloomberg. "A positive result for Niaspan and Simcor in HALTS could represent upside potential to our Abbott estimates." But though LeCroy also suspected Niaspan worked better, he said he wouldn't rule out a Zetia victory, or a tie.
- get the scoop from Dow Jones
- read the Bloomberg piece
Related Article:
Where Merck loses, Abbott gains
Comments
By Anonymous | Posted 11:51am | July 9, 2009
If Niaspan was the winner, then why would a NIH trial funded by Abbott be terminated? Could it be that since these patients were already on a statin, that neither drug showed "significant" efficacy to reduce CIMT as measured by ultrasound technique. The efficacy of add on molecules to statins are minute as compared to the efficacy of statins in treatment naive patients. CIMT results using ultrasound technology as designed in these trials is useless. While each molecule may provide protective results, the technology isn't senistive enough to showit. Other CIMT trials using ultrasound technique have been terminated over the past 6 months due to the same problems.
Ultrasound techniques only work on treatment naive patients.
By Anonymous | Posted 10:30pm | September 20, 2009
I agree witht he second comment you should not speak on matters you know nothing about. Zetia has had three failed trials the SEAS trial witch showed no better than statin alone, ENHANCE trial which showed NO regression, and the SANDS trial that showed no better than statin alone. Niaspan however has shown 70-90% event reduction in over 4 different trials (HATS, FATS, CLAS, and ARBITER II). Niaspan/Niacin has also showed DISEASE REGRESSION in 4 different trials (HATS, FATS, CLAS, and ARBITER II). Niaspan is the most uderutilized drug in the cholesterol market. Physicians should be ashamed for not using more of this life saver.
By Anonymous | Posted 11:11am | July 10, 2009
You should not speak about things you know nothing about. Read the studies before you make uninformed, ignorant comments (and try using spell check too). Arbiter 2, using CIMT, showed very significant additional benefits beyond statin therapy, to patients that were not treatment naive and were pretty close to if not controlled on a statin alone.
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