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Abbott Statement on ARBITER 6 - HALTS Results and Abbott's Niaspan (niacin extended-release)
Date:11/15/2009

not statistically significant.

ARBITER 6 - HALTS

The ARBITER 6 - HALTS study explored treatment approaches in patients at high cardiovascular risk already taking statins to control bad LDL cholesterol. The primary endpoint of the study compared the effect on atherosclerosis of raising good HDL cholesterol with the addition of Abbott's Niaspan to a statin versus LDL-lowering with the addition of ezetimibe. There were four secondary endpoints: change in lipid values; a composite endpoint consisting of MACE; drug discontinuation due to adverse effects; and health-related quality of life. ARBITER 6 - HALTS, led by Allen Taylor, M.D., of Washington Hospital Center, was conducted and analyzed independent of Abbott. Abbott provided funding and medication to support the study.

ARBITER 6 - HALTS Study Design and Patient Population

ARBITER 6 - HALTS is a prospective, randomized, parallel group, open-label, blinded endpoint study, which means the treatment was not blinded to patients or the investigators, but the analyses of scans were blinded. The study included 362 patients with coronary heart disease or risk equivalents, LDL less than 100 mg/dL and HDL less than 50 for men or 55 mg/dL for women receiving chronic statin therapy. Baseline mean HDL in the study was 43 mg/dL and mean LDL was 82 mg/dL. At the time of the pre-specified interim analysis, the 208 patients who completed treatment and final imaging were included in the analysis.

NIASPAN Indications

NIASPAN is a prescription medication, used along with diet and exercise, to improve cholesterol levels. NIASPAN raises HDL ("good") cholesterol and lowers LDL ("bad") cholesterol and triglycerides. Niacin is also used to reduce the risk of recurrent heart attacks in patients with high cholesterol. In patients with coronary artery disease and high cholesterol, niacin, in combination with a bile acid binding resin, has b
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