WASHINGTON, Dec. 16 (UPI) -- 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.