Final results of the eagerly-awaited and hugely controversial IMPROVE-IT trial are last but not least going to be revealed. The American Heart Association has announced that the trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions . IMPROVE-IT compared the impact on cardiovascular outcomes of the statin simvastatin with Vytorin (the mixture of simvastatin and ezetimibe, manufactured by Merck) in more than 18,000 individuals with acute coronary syndromes.
Both Vytorin and Improve-IT have been the topic of significant controversy. The drug was approved, and widely employed, regardless of the absence of clinical trials demonstrating benefit. The Improve-IT trial, which was developed to assess the result of clinical outcomes, has taken several years to attain completion. Some observers have pointed out that the trial’s length has closely paralleled the patent daily life of the drug.
But Boost-IT might have critical implications beyond our knowing of ezetimibe. It is extensively believed that the trial will provide a substantial contribution to the debate about the reliability of surrogate endpoints in general and the independent relevance of lowering LDL cholesterol in distinct. I have argued in the past that the fate of the new PCSK9 inhibitors may possibly depend on the outcomes of Improve-IT:
If Boost-IT meets its primary endpoint then the FDA will be far much more inclined to accept LDL-lowering as a surrogate endpoint and the PCSK9 inhibitors may possibly well achieve early approval (if all else goes properly, of program, however this is by no means assured). On the other hand, if Boost-IT does not meet its principal endpoint then the FDA will be significantly significantly less most likely to approve a new class of cholesterol-reducing medicines with out evidence of substantial clinical positive aspects.
Increase-IT Trial Scheduled For Presentation In November
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