SIMCOR Is a New Single-Pill Combination of Two Proven Therapies that
Significantly Raises HDL "Good" Cholesterol and Lowers LDL "Bad"
ABBOTT PARK, Ill., Feb. 15 /PRNewswire-FirstCall/ -- Today, Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.
"Managing cholesterol encompasses many factors, not just lowering LDL. There is a clear need for medicines that both raise good and comprehensively lower the bad components of cholesterol," said Christie Ballantyne, M.D., the Methodist DeBakey Heart and Vascular Center, Houston, and lead SIMCOR investigator. "SIMCOR represents an important new option to help patients reach healthy lipid levels."
An estimated 80 million Americans have high levels of the bad LDL cholesterol, and more than 44 million have low levels of the good HDL cholesterol, which the body uses to remove bad cholesterol from the bloodstream. Studies have shown that along with diet, SIMCOR can help patients with lipid disorders reach their treatment goals by addressing more than just bad cholesterol, targeting multiple lipids with one pill.
The FDA's approval was based on SIMCOR safety and efficacy trial data
from more than 640 patients with mixed dyslipidemia and type II
hyperlipidemia. In the SEACOAST clinical trial, patients receiving SIMCOR
1000/20mg achieved significant cholesterol improvements over and above what
simvastatin 20mg alone provided. Patients treated with SIMCOR 1000/20mg had
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