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Abbott’s Simcor achieves primary endpoint in Phase III study

Abbott Laboratories has presented new Phase III data showing that Simcor, the fixed-dose combination of its proprietary extended-release niacin, Niaspan, and simvastatin has met its primary endpoint of lowering plaque-promoting non-HDL cholesterol, while demonstrating improvements on other key lipids, LDL bad cholesterol, HDL good cholesterol and triglycerides.

Patients in the study treated with a Simcor combination containing 20mg simvastatin had significantly better reductions in non-HDL (total cholesterol minus HDL) cholesterol compared to 20mg simvastatin therapy alone, as well as significant improvements in HDL and triglyceride levels.

Patients receiving a Simcor combination with 40mg simvastatin experienced reductions in non-HDL comparable to 80mg simvastatin alone, and significantly better improvements in HDL and triglycerides compared with 80mg simvastatin alone. 6% of patients on the combination discontinued therapy due to flushing compared to 0.8% with simvastatin alone.

Christie Ballantyne, Baylor College of Medicine and Methodist DeBakey Heart Center, Houston, Texas, and lead investigator on the study, said: “Patients know that it’s important to manage the bad cholesterol, but it’s essential to control HDL and triglyceride levels as well. With the Phase III (SEACOAST) study, Simcor provided comparable LDL lowering to simvastatin with significant benefit in raising good cholesterol and lowering triglycerides. This type of combination approach could be an important tool in treating patients with complex lipid disorders.”