MSD and Schering-Plough announce Enhance panel meeting

Merck, Sharp and Dohme (MSD) and Schering-Plough have announced the meeting of an independent clinical and biostatistics panel to provide an update on the Enhance study comparing the use of Inegy with simvastatin in patients with heterozygous familial hypercholesterolemia (HeFH).

The panel has recommended that the primary endpoint of the trial, whose clinical portion is now complete, be focused on the common carotid artery to speed up the reporting of the study findings.

MSD and Schering-Plough expressed the hope that the full results of the trial will be presented at the annual meeting of the American College of Cardiology in March 2008.

The main goal of the Enhance trial is to measure changes in the intima media thickness at the internal carotid, the carotid bulb and the common carotid at the start of the study and at two years using an innovative non-invasive methodology.

John Kastelein, professor of medicine and chairman of the Department of Vascular Medicine at the Academic Medical Centre in Amsterdam, said: “We view the experts panel’s recommendation to narrow the primary endpoint to the common carotid artery as helpful, and we will continue to expedite the completion of Enhance and reporting of its results, while ensuring the integrity of the data.

He added that the Enhance study is complex and is being carried out with great diligence.

In June 2006, Schering-Plough reported that Inegy is “significantly more effective” at reducing levels of LDL-cholesterol when compared to Crestor, the statin from AstraZeneca.