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Vytorin ads Enhance warning language

Executive Summary

DTC print advertisements for Merck/Schering-Plough's Vytorin (ezetimibe/simvastatin) began carrying a bolded warning March 30 to highlight safety signals identified in the ENHANCE study. The print ad, "Do you have high LDL (bad) cholesterol," ran through April 6 and contained a statement that "Vytorin has not been shown to reduce heart attacks or strokes more than Zocor alone." The statement also will appear in broadcast ads for the drug, the firm tells "The Pink Sheet." The Vytorin buzz shares the DTC spotlight with Pfizer's ads for Lipitor, which gained attention for its celebrity endorsement by Robert Jarvick last month (1"The Pink Sheet," March 3, 2008, p. 10)

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Vytorin (correction)

Print DTC ads emphasizing the ability of Merck/Schering-Plough's Vytorin to reduce LDL-cholesterol levels began running on March 30. Following an FDA request in January, the ads carry the disclaimer that "Vytorin has not been shown to reduce heart attacks or strokes more than Zocor alone." A recent article mistakenly said the statement is being included in DTC ads as a result of safety signals identified in the ENHANCE trial (1"The Pink Sheet," April 14, 2008, In Brief). Furthermore, no new safety signals were associated with Vytorin treatment in the ENHANCE trial

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