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Home Industry News MSD and Schering-Plough respond to Enhance trial concerns

MSD and Schering-Plough respond to Enhance trial concerns

28th January 2008

Merck, Sharp and Dohme (MSD) and Schering-Plough have responded to concerns raised regarding the Enhance trial that assessed the combination of ezetimibe and high-dose simvastatin compared to simvastatin alone on the atherosclerotic process in heterozygous familial hypercholesterolemia patients.

The companies report that – though time-consuming and taking longer than originally forecast to complete – both firms acted in good faith and with integrity regarding the trial, taking a number of actions to ensure the quality of the reading of ultrasound images in the study.

MSD said that Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe) have both been extensively studied in patients with high cholesterol and have been shown, in conjunction with a healthy diet, to reduce LDL cholesterol in these patients.

Thomas Koestler, president, Schering-Plough Research Institute, said: “Vytorin and Zeita are important treatment options that can help appropriate patients lower their LDL cholesterol.”

He added that over two decades of clinical research have shown that, combined with therapeutic lifestyle changes and a more healthy diet, lowering LDL cholesterol is the foundation of lipid treatment for patients at risk of heart disease.

In November 2007, MSD and Schering-Plough expressed the hope that the full results of the Enhance study will be presented by at the annual meeting of the American College of Cardiology in March 2008.

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