Abbott's new combination heart pill Simcor has positive effects on ‘good’ and ‘bad’ cholesterol as well as triglycerides and other key lipids that lead to coronary disease, according to results presented at the American Heart Association's Scientific Sessions in Orlando, Florida.

Simcor combines the firm’s Niaspan (extended-release niacin) and simvastatin, the active ingredient in Merck & Co’s Zocor which came off-patent last year. The drug, which targets high-density lipoprotein or ‘good’ cholesterol, as well as low-density lipoprotein ‘bad’ cholesterol plus triglycerides in a single pill, was filed with the US Food and Drug Administration in April 2007.

"These results indicate that Simcor can go beyond what simvastatin alone can provide," said lead investigator Dr Christie Ballantyne, medical director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center in Houston. "This type of combination approach could be an important tool in treating the increasing number of patients with complex lipid disorders, metabolic syndrome and heart disease."

Treatment of high cholesterol has historically centred on the use of statins, including simvastatin, to lower LDL cholesterol. However, "we now place more importance on comprehensive cholesterol management, including management of HDL levels, in impacting cardiovascular risk," Dr Ballantyne said. "Medications like Simcor can help patients address multiple problems with one pill."

The 24-week double-blind, randomised, controlled trial conducted at the Methodist DeBakey Heart Center and other sites across the US, compared simvastatin alone against Simcor in more than 600 patients with elevated non-HDL (type II hyperlipidaemia or mixed dyslipidaemia).

Patients in the study given a Simcor combination containing 20mg simvastatin had significantly better reductions in non-HDL (total cholesterol minus HDL) compared to 20mg simvastatin therapy alone, as well as significant improvements in HDL and triglyceride levels. Those receiving a Simcor combination with 40mg simvastatin experienced reductions in non-HDL comparable to 80mg high-dose simvastatin alone, and significant improvements in HDL and triglycerides.

Significantly, combination treatment resulted in improvements in HDL of between 15% and 25% compared to just 1% to 7% in those patients receiving simvastatin alone. The researchers say that Simcor met its primary endpoint of lowering non-HDL cholesterol and demonstrating improvements on LDL, HDL and triglycerides. Niacin is known to raise HDL and statins reduce LDL cholesterol and triglycerides.

Treatment with four different doses of Niaspan combined with simvastatin for 24 weeks was well tolerated. There was no evidence for increased risk of liver toxicity or muscle damage with the combination. <i>By Michael Day</i>