News | April 01, 2008

ACC/AHA Respond to Grassley's Letter on ENHANCE

April 1, 2008 - The American College of Cardiology (ACC) and American Heart Association (AHA) responded to Senate Finance Committee's senior Republican, Charles Grassley of Iowa, regarding his concerns about reports that two pharmaceutical companies delayed the release of the results from the ENHANCE trial.

The ENHANCE study, which was presented at the American College of Cardiology's 57th Annual Scientific Session on Sunday, March 30, 2008, and published online in the New England Journal of Medicine, compared the effect on carotid artery thickening of simvastatin alone versus simvastatin plus ezetimibe in patients with a genetic condition that causes severe increases in serum cholesterol. The results of the trial showed no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone in terms of affecting the rate of atherosclerosis progression.

In a letter from Senator Grassley to the ACC, Grassley said that he was "troubled by reports that Merck and Schering Plough (M/SP) were delaying results of the ENHANCE trial," a study which examined whether Vytorin provides better health benefits than generic simvastatin-a drug that is far less expensive than Vytorin. The ENHANCE trial was completed in April 2006, but the results were not released for almost two years."

"Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government,"? he added.

Responding to Grassley's concerns, ACC CEO Jack Lewin, M.D., wrote a letter, in which the ACC/AHA Statement was enclosed, "We recognize the concerns regarding the delayed release of the data in the ENHANCE trial, and we were pleased to be able to provide a scientific venue to discuss the complete data from this study, and a forum to discuss the implications of the data on behalf of our members and their patients."

The ACC/AHA statement, which was issued on March 31, 2008, said, "While some of these data had been released previously, a complete peer-reviewed presentation had not been available." It added, "The study reinforces the need to adhere to current American College of Cardiology/American Heart Association Guidelines, which recommend statins to the maximally tolerated dose or to goal as first line treatment for patients with coronary artery disease. The data from the ENHANCE study should be considered as the NHLBI guidelines writing group is working on their update of the national cholesterol treatment guidelines in the coming months. Patients should speak with their physician before discontinuing any therapy."

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