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Web Date: April 1, 2008

Stay With Statins

Companies respond to panel's suggestion that patients avoid some cholesterol-lowering drugs
Department: Science & Technology

Merck & Co. and Schering-Plough are firing back after a panel of five medical experts suggested at an American College of Cardiology (ACC) meeting on Sunday that doctors should not prescribe the companies' Zetia (ezetimibe) and Vytorin (simvastatin and ezetimibe) cholesterol-lowering drugs.

The ACC recommendation came after the release of clinical trial results that showed the two products, while safe, were no more effective for lowering cholesterol than statin-based drugs alone. Several other doctors echoed this conclusion in editorials published on Sunday along with the trial results on the New England Journal of Medicine website (DOI:10.1056/NEJMoa0800742).

Although the trial results were not a complete surprise???preliminary results were released in January???the ACC panel's conclusion was. Stock prices for Merck and Schering-Plough fell 15% and 26%, respectively, on March 31. Meanwhile, shares rose in companies such as Pfizer and AstraZeneca that market competing statin drugs.

The trial was called Enhance, for Ezetimibe aNd simvastatin in Hypercholesterolemia enhANces atherosClerosis rEgression.

Merck and Schering-Plough are defending the products. Patients may be "questioning the benefit of these medicines ??? on the basis of a single study that has generated a lot of confusion," the joint venture says in a message posted on its website. "All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of Zetia and Vytorin."

The companies emphasize that multiple clinical trials involving thousands of patients have shown that the drugs, along with diet, lower LDL (bad) cholesterol. They also point out that the Enhance study looked only at patients with a rare genetic condition that causes very high LDL levels and increases the risk of premature coronary artery disease. Although LDL levels declined, the companies are uncertain as to why other main goals of the trial—changes in artery wall thickness, for example—were not achieved.

ACC said in a statement that the Enhance study results reinforce "current American College of Cardiology/American Heart Association guidelines, which recommend statins as first-line treatment for patients with coronary artery disease." Additional clinical trial data on ezetimibe alone may be available by 2012.

Merck and Schering-Plough have been strongly criticized for taking more than a year to release the study results. "While the Enhance trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial," said Thomas Koestler, president of the Schering-Plough Research Institute, when preliminary results were disclosed in January.

Merck and Schering-Plough formed a joint venture in 2000 to develop cholesterol-lowering drugs. Merck had sold simvastatin for years as the blockbuster Zocor. The drug reached peak annual sales of $5.2 billion in 2004 but lost patent protection in 2006. Merck hoped to extend the franchise by combining the drug with Schering-Plough's ezetimibe, which was approved in 2002. Vytorin was approved in 2004; the joint venture's combined sales of Zetia and Vytorin were $5.2 billion in 2007.

 
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