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【drug-news】默克再度喊停降血脂药临床试验
Once Bitten, Merck Halts Cholesterol Drug Study
Posted by Jacob Goldstein
Imagine a clinical trial of a experimental cholesterol drug that looked an awful lot like a study of a top-selling cholesterol fighter that just turned into a widely publicized debacle for your company. Now throw in the fact that the unapproved cholesterol drug you’re testing in the trial was recently rejected by the FDA. What would you do? Probably pull the plug, right?
That’s just what Merck did today, halting its ‘Achieve’ trial of the experimental cholesterol drug Cordaptive.
The trial enrolled patients with a genetic predisposition to high cholesterol, and used the thickness of the walls of the carotid artery (a measure known as cIMT) as a measure of coronary health. That may sound familiar: It’s the same setup researchers used in the Enhance trial, which compared the effects of Vytorin (sold by Merck and Schering Plough) to a statin and failed to show improvement.
“It was clear from the Steering Committee’s review of pooled data from recently completed cIMT studies of other medicines that the patient population being studied in ACHIEVE was no longer the correct population to test the primary study hypothesis of IMT progression,” John Kastelein, chair of the study’s steering committee, said in Merck’s statement. Kastelein, loyal Health Blog readers will recall, also ran the Enhance study.
Merck said the FDA’s recent rejection of Cordaptive had nothing to do with the decision to halt the Achieve study, and preliminary data didn’t suggest any safety concerns. The company said this 20,000 patient study of the drug will continue unchanged.
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作者:admin@医学,生命科学 2010-11-05 17:11
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