FDA Panel Recommendation on Crestor Spurs Debate

The FDA is not obligated to follow the advisors recommendations, but it often does. If it did so this time, it would mark a first -- a drug normally used to lower dangerously high LDL (bad) cholesterol in people with a history of heart disease or risk factors to develop heart attacks or strokes would be approved for the prevention of heart attacks in healthy people.

The basis for the new indication was the JUPITER study of almost 18,000 men and women, average age 66. The JUPITER trial was sponsored by AstraZeneca, the company that markets Crestor.

All patients in the study had no history of heart disease, but did have an elevated CRP level.

Patients in the study took 20 mg of Crestor or a sugar pill placebo for 1.9 years. At the end of that time, the patients taking Crestor had an average LDL cholesterol of 55 mg/dL-- down from 109 mg/dL when they started the study.

And compared with patients who took the placebo, the Crestor patients had a 44 percent reduction in heart attacks, stroke, need for surgery or stenting to open clogged arteries, or death from heart disease.

For every 25 people treated with Crestor, a heart attack, stroke, or death was prevented.

Weighing Risks and Benefits of Crestor

Those results, according to Dr. Melvyn Rubenfire of the University of Michigan, were a "home run for JUPITER" but it is not clear if the results would be same with another statin.

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."

The debate once again raises the specter of a medical practice which some say does not have evidence to back its necessity – and may even be harmful – but which others say could be life-saving.

It is not the first recommendation to enter this realm. Recently, the debate over the necessity and balance of risks and benefits for mammograms ignited similar controversy with regard to breast cancer screening.

And though doctors' opinions were split largely according to their specialties, the lines between supporters and detractors were not completely clear-cut.

Dr. Merle Myerson, director of the Cardiovascular Disease Prevention Program at St. Luke's-Roosevelt Hospital in New York, disagreed with the conclusions of the panel.

"This is surprising," Myerson said. "The research on CRP is still not conclusive in terms of the benefit and specificity of CRP's predictive value. This approval would open up a huge new category for treatment. My feeling is that this is premature and not substantiated."

  • 1
  • |
  • 2
  • |
  • 3
Join the Discussion
blog comments powered by Disqus
You Might Also Like...