More Information Sought on Cholesterol Drug Vytorin

Members of a Congressional panel investigating the cholesterol-fighting drug Vytorin want more information about clinical trials of the drug, which has been linked to an increased risk of heart attacks and strokes.

Vytorin, marketed by Merck and Co. and Schering-Plough Corp., is a cocktail containing the drugs Zetia and Zocor. However, some studies have found the drug can lead to heart-related deaths.

This week, Congressman Henry Waxman (D-Cal.), who is chairman of the Energy and Commerce Committee, sent a letter to the two companies seeking additional documents about clinical trials currently underway. Specifically, Waxman requested more information about patient safety monitoring boards, which are charged with overseeing several clinical trials.

The committee investigation into Vytorin is ongoing and the companies reportedly plan to comply with the request for documents.

Effectiveness of Vytorin Questioned

The effectiveness of Vytorin as a cholesterol fighter has been questioned recently. The drug is approved for the treatment of high cholesterol, but some studies have found the drug is no better than Zocor, a cheaper generic drug, taken alone.

There have also been questions about the handling of data from a clinical trial of the drug, called Enhance, and accusations that the release of the results has been intentionally delayed by the companies.

Data from another Vytorin clinical trial, called Seas, and two other trials – known as Sharp and Improve It — should be released soon, officials said.

No related posts.