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FDA Committee Agrees With Wider Use of Crestor – Is The Jupiter Study Data Creeps Up Once Again

Posted Dec 28 2009 6:15pm

We are back to the Jupiter study that came out not too long ago about expanding the use of cholesterol reducing drugs.  The study involved individuals taking Crestor that were within normal cholesterol ranges, but had some type of heart disease.

We only have a little over a year left until Lipitor from Pfizer comes off patent and then the cholesterol generics will flood the market.  Are we only looking at the report or are we getting the full story with side effects and all?  Crestor's patent is already scheduled in court cases to start in February. 

Last year on a post I quoted something from the Happy Hospitalist and his opinion and I think it is worth repeating about now:

The Jupiter Report with Crestor – What Side effects?

“What if we all took Crestor to reduce the chance of developing heart disease?  Happy Hospitalist does a pretty good job here on lining it all up!  Talk about side effects.  BD 

  • All Americans will now get Crestor to reduce their CRP to reduce their chances of developing heart disease. 
  • All Americans Will now get lisinopril to prevent the proteinuria they will get from their diabetes they get from Crestor
  • All Americans will now take metformin to treat the diabetes they developed while taking Crestor
  • All Americans will now take Lyrica to prophylax  for the the neuropathic pain they will get from developing diabetes while taking Crestor.
  • All Americans will now take an aspirin to reduce the risk of developing a stroke from the diabetes they got from taking Crestor.
  • All Americans will now take prilosec to reduce the risk of developing an ulcer from the aspirin they were taking to reduce the risk of stroke due to the diabetes they developed while taking Crestor to reduce their asymptomatic CRP level.
  • All Americans will now take carvedilol to reduce the risk of death from the coronary artery disease they developed as a result of the diabetes they developed as a result of the Crestor they were taking to reduce their CRP to reduce their chances of developing coronary artery disease. “

AstraZeneca (AZN) received a positive opinion from the US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) regarding the expanded use of Crestor. AstraZeneca is seeking approval for Crestor to treat patients with normal cholesterol levels but having other risks of heart disease. The committee voted 12-4 in favor of Crestor after analyzing its benefit against possible risk in some patients. However, the committee was concerned that Crestor should not be used at random in patients with low risk.

Following the recommendation, AstraZeneca has moved one step closer to FDA approval. Although the FDA is not required to follow the committee’s opinion, it generally does so.

FDA Backs Crestor's Wider Use - Analyst Blog | Benzinga.com

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