FDA Panel Recommends Crestor to Prevent Heart Attacks in Healthy People

Noting that the panel's vote was a "somewhat courageous decision", Rubenfire said the "issue now is how the FDA, physicians, and insurers approach the results. That is, 'are all statins the same?' The robustness of the results are unique to Crestor."

But there were some risks associated with Crestor, including 13 deaths due to gastrointestinal disorders in study subjects taking rosuvastatin, and 18 patients reported a "confused state" while taking the drug.

The most troubling adverse event, however, was an uptick in investigator reported new onset diabetes mellitus in the treatment arm, 2.8 percent versus 2.5 percent, or an increased risk of 27 percent.

Although the advisory committee agreed that the benefit of rosuvastatin outweighed the risk, it said that patients should be carefully monitored for diabetes and they admonished the manufacturer to "carefully define the target population in marketing materials."

Crestor is marketed by AstraZeneca, which also sponsored the JUPITER trial.

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