WASHINGTON, Dec 16, 2009 (UPI via COMTEX) -- A panel of the U.S. Food and Drug
Administration voted to recommend the cholesterol lowering drug Crestor be
approved for those with inflammation.
If the FDA follows the panel's recommendation -- which came on a vote of 12-4 --
rosuvastatin, or Crestor, would be approved for patients with no history of
heart disease but who had elevated levels of the inflammatory biomarker
C-reactive protein, Medpage Today reported Wednesday.
A study comparing patients on rosuvastatin to patients receiving a placebo found
the number of cardiovascular events -- death, stroke, heart attacks,
hospitalization for heart problems and surgery to treat clogged arteries --
dropped by 44 percent among those on the drug.
However, there was a statistically significant increase in study subjects who
developed diabetes in the Crestor group compared to the placebo group. In
addition, 13 died due to gastrointestinal disorders in the Crestor group and 18
patients reported a "confused state" while taking the drug.
The panel said the benefit of rosuvastatin outweighed the risk but patients
should be carefully monitored for diabetes and it directed the manufacturer
AstraZeneca to "carefully define the target population in marketing materials."
The randomized, placebo-controlled trial of 17,802 men and women had a mean age
of 66, no history of atherosclerosis, low-density lipoprotein of less than 130
mg/dL and a highly sensitive C-reactive protein concentration of 2 mg/L or
higher.
URL: www.upi.com
Copyright 2009 by United Press International