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Abbott's Investigational SIMCOR(R) Offers Comparable LDL Lowering to Simvastatin and Significantly Raises HDL and Lowers Triglycerides in Phase III Study
Date:11/4/2007

In the high-dose group, patients treated with SIMCOR combination therapy showed similar (non-inferior) improvements in non-HDL of 11 percent (1000 mg/40 mg) and 17 percent (2000 mg/40 mg) compared to a 10 percent improvement with 80 mg simvastatin therapy alone. Additionally, the high-dose combination group demonstrated significant improvements in HDL of 15 percent (1000 mg/40 mg) and 22 percent (2000 mg/40 mg) compared to a 1 percent decrease among those receiving 80 mg simvastatin monotherapy. Triglyceride levels among the high-dose combinations groups dropped 23 percent and 32 percent, respectively, in contrast to a 0.3 percent increase in those randomized to 80 mg simvastatin monotherapy.

Treatment with the four different doses of Niaspan combined with simvastatin for 24 weeks was well tolerated. There was no evidence for increased risk of hepatotoxicity or myopathy with the combination.

Treating Beyond LDL

Treatment of high cholesterol has long centered on the use of statins, including simvastatin, to lower LDL cholesterol, which has been the primary target of therapy. Clinical consensus now also emphasizes the importance of comprehensive cholesterol management, including management of HDL levels, in impacting cardiovascular risk.

In fact, a recent post-hoc analysis of 9,770 patients from the Treating to New Targets study, published in the New England Journal of Medicine, concluded HDL levels were predictive of major cardiovascular events in patients treated with statins, and also observed in patients with LDL levels below the National Cholesterol Education Program's most aggressive target of 70 mg/dL.

"We hope to make comprehensive cholesterol treatment more effective, more tolerable and more convenient for patients at risk for cardiovascular disease," said Eugene Sun, M.D., vice president of Global Clinical Development, Abbott.

About Niaspan

Available since 1997, Niaspan is the only FDA-approved, once-daily extended-r
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SOURCE Abbott
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