Crestor Problems Mount for AstraZeneca As Drug Fails to Outdo Lipitor In Study

According to a new study funded by AstraZeneca, their cholesterol drug Crestor does not appear to provide any benefit over Lipitor, which should become available as a generic later this year, adding to the potential problems the drug maker faces with their blockbuster medication. 

Although AstraZeneca hoped that the results of the clinical trial would provide Crestor a boost when facing competition from generic Lipitor, the results released on Friday failed to show that patients taking Crestor received any significant benefit.

The clinical trial, known as Saturn, found that there was no statistically significant difference between the amount of artery-clogging plague in patients who were given Crestor and Lipitor. The findings are particularly important because Lipitor’s patent is preparing to expire in October, meaning that Lipitor will become significantly cheaper than Crestor, leaving doctors with little reason to prescribe the more expensive drug.

AstraZeneca researchers pitted Crestor against Lipitor in the clinical trial with the hopes to show that the drug outshined its rival ahead of the expected Lipitor price drop. However, the clinical trial’s results were likely not what the company wanted to see.

The study also comes amid building momentum for potential Crestor lawsuits being investigated by a number of lawyers throughout the United States on behalf of users who developed heart problems like cardiomyopathy, diabetes and other injuries that may have been caused by side effects of Crestor.

Earlier this year, at the annual convention for the American Association for Justice, a Crestor litigation group was formed by a group of lawyers representing plaintiffs, so that they could meet and coordinate strategy against AstraZeneca regarding the possible cardiomyopathy lawsuits over Crestor.

In 2005, the non-profit consumer advocacy group, Public Citizen, filed a petition with the FDA calling for a Crestor recall to be issued due to the potential risk of health problems with Crestor and because there appear to be safer alternatives on the market. The FDA has not heeded the request, and Crestor has not been removed from the market.

Crestor (rosuvastatin) was approved by the FDA in 2003. The FDA has twice issued warnings that Crestor could cause heart, muscle and kidney problems. Crestor belongs to a group of cholesterol drugs known as statins, which includes Lipitor, Zocor, Vytorin and a number of other drugs.

The complete results of the Saturn clinical trials will be released November 15 at the annual American Heart Association meeting.