An interim analysis for one of Merck's ($MRK) top pipeline programs has been delayed by several months. Originally slated for late 2011, Merck now says the second interim analysis of IMPROVE-IT, which is testing its closely-watched cholesterol drug Vytorin as a tonic for cardio risks, will be pushed back to early 2012. But company officials say the delay won't affect Merck's plans to wrap the study in 2013, according to a report from Reuters.
Vytorin is a combination of Zocor (simvastatin) and Zetia (ezetimibe). The IMPROVE-IT trial is designed to demonstrate the drug's ability to reduce the risk of heart problems--including chest pains and angina--in patients with acute coronary syndrome. Investigators will conduct an interim analysis for efficacy when about 75% of the pre-specified primary clinical endpoints have occurred, Merck said in a release. Roughly 70% of its pre-specified events have been reported so far.
Merck surprised some analysts in the fourth quarter of last year when it announced the results of the SHARP trial, which showed Vytorin "significantly reduced major vascular events in patients with chronic kidney disease."
- here's the Merck release
- read the story from Reuters