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Schering-Plough last week reported a 19% drop in second-quarter profit as Vytorin sales fell 9% to $1.2 billion.
The company, which markets ezetimibe as a solo agent (Zetia) and in combination with simvastatin (Vytorin), had been under pressure to release results from the trial, which ended in April 2006.
The letters come less than two weeks after the committee's health panel questioned lower-ranking executives from the drugmakers about aggressive marketing tactics for two cholesterol drugs - Pfizer's Lipitor and Merck and Schering-Plough's joint venture Vytorin. The committee also probed ads for J&J's anemia drug Procrit.
ATLANTA -- The ezetimibe/simvastatin combination pill Vytorin has a markedly greater anti-inflammatory effect, as reflected by reduction of C-reactive protein, than either agent alone, Dr.
The more stringent target of an LDL below 70 mg/dL plus a CRP of less than 2 mg/dL was met by 21.6% of the Vytorin group and 3.2% of patients on simvastatin alone.
Schering and Merck already jointly sell the cholesterol drugs Vytorin and Zetia.
A House committee investigating the safety and effectiveness of the popular cholesterol drug Vytorin and one of its components is turning up the heat on the drug's makers.
Is no longer on speakers' bureau of Merck (Zocor, Mevacor, Vytorin).James De Lemos, M.D., assistant professor of medicine, division of cardiology, University of Texas Southwestern Medical Center, Dallas.
58 Merck/Schering Vytorin 66582031331 $ 540,395,556
New products would help Schering-Plough reduce dependence on cholesterol medicines Vytorin and Zetia, which have seen a decline in prescriptions.
The Food and Drug Administration said that it is considering, but has not yet determined, whether data from the ENHANCE study of Vytorin warrants any regulatory action.
Merck already sells several blockbuster heart drugs, including blood pressure treatments Cozaar and Hyzaar and two cholesterol drugs that it sells with Schering-Plough Corp., Vytorin and Zetia.