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【drug-news】Vytorin临床对比试验失败,麻烦接二连三
January 14, 2008, 2:12 pm
Unenhanced Results for Zetia and Vytorin
Posted by Shirley S. Wang
Now that the findings of the Enhance study are out and show that the combination of Zetia and Zocor is no better than taking Zocor alone when it comes to a marker for atherosclerosis, what’s it all mean for Zetia and the combo pill Vytorin?
We talked to a couple of cardiologists to get their take. Robert Califf, vice chancellor for clinical research , at Duke University and co-principal investigator on Merck/Schering-Plough’s ongoing study of Zetia’s effect on heart attacks and strokes, known as the IMPROVE-IT study, wasn’t involved in the Enhance study. Linda Hemphill is a preventive cardiologist at Harvard who has worked on clinical trials with Merck before but gets no funding from the company now.
Both Califf and Hemphill told the Health Blog they were “disappointed” by the study results, but believe that it’s not a big deal that the results didn’t show a difference in the thickness of arterial walls, the study’s primary endpoint. (The thickness of the wall of the carotid artery, measured on ultrasound, is an indicator of the progression of atherosclerosis.) Rather, it’s the IMPROVE-IT study that will provide the definitive results on whether adding Zetia will actually reduce stroke, heart attacks and ultimately death better than Zocor alone, says Califf. Data from that trial won’t be available for at least two or three years.
Will these Enhance study results change the doctors’ clinical decisions? Hemphill says she’ll continuing prescribing Zetia in combination with a statin for patients with the inherited from of high cholesterol studied in Enhance because the combination reduces LDL more than Zocor alone. “Will I find Zocor alone acceptable in this patient population? No, I will go with the LDL level and get it as low as possible. The fact that [the study] doesn’t show a difference [in carotid artery thickness] isn’t going to change my practice.”
Califf has a slightly different take for the broader use of the Zetia. “I think in cases where people mistakenly thought it was proven this drug reduced vascular events, this will add more public knowledge that this is not the case. We don’t know that yet. I think in places where people were using it based on misimpressions, they’ll use it less,” he told the Health Blog.
“From my perspective, whenever you talk about a biomarker-like imaging study, it’s interesting but shouldn’t be the basis of clinical decisions,” he adds. “I think most thoughtful people won’t be much affected by the study because they’re waiting for the outcome trial.”
Califf, who takes Zetia alone himself, says that he will stick with it unless findings come out showing that the drug makes no difference on clinical events, such as heart attacks. (He doesn’t take simvastatin because of side effects.) Until that point, he says, “I’m only losing money.”
That’s for sure. A 30-day supply of the 10 milligram dose of Zetia costs $92.99 at drugstore.com. Vytorin (10 mg ezetimibe and 80 mg simvastatin) will set you back $100.99 for a month’s supply. Generic Zocor costs $32.33 for a month’s supply of 80 mg tablets. Will other patients, and their insurers, be as willing to bear the higher cost as Califf? January 14, 2008, 9:11 am
Zetia Doesn’t Enhance Zocor
Posted by Shirley S. Wang
The long-delayed and much-speculated-about data from Merck and Schering-Plough’s Enhance study comparing whether a combination of Zetia and Zocor works better than Zocor alone were finally released today.
Bottom line: Zetia, or ezetimibe generically, didn’t bring anything important to the cholesterol party. That’s bound to be a bummer for sales of Zetia and Vytorin, the drug that combines Zocor, now sold generically as simvastatin, and ezetimibe.
The telling detail: there was no statistically significant difference in the primary endpoint of the study, a marker of atherosclerotic changes in the arteries called intima-media thickness, according to a Schering-Plough press release. Important secondary endpoints, the fallbacks for worried study designers, also showed no statistical difference between treatment groups.
The results of this two-year-long trial of 720 people with heterozygous familial hypercholesterolemia (HeFH), a rare, inherited form of high cholesterol that affects about 0.2% of the population, have been eagerly anticipated. The study was finished in 2006, and the findings were expected to be disclosed finally in March at a meeting of heart doctors.
The delay in the release of the results led to suspicions, now confirmed, that Zetia wasn’t helping Zocor much in battling cardiovascular disease.
Three more large trials of Vytorin in high-risk patients are underway, including the 10,000-patient IMPROVE-IT trial. Thus far, there are no data that show that the combination of Zetia and Zocor are better than Zocor alone in reducing cardiovascular illness and mortality.
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作者:admin@医学,生命科学 2011-04-19 05:14
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