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news.Primary endpoint was to compare the effect on atherosclerosis of raising good HDL cholesterol with the addition of Niaspanto
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Abbott has reported results from the ARBITER 6 – HALTS study showed patients at high cardiovascular risk had significant regression of atherosclerosis after 8 and 14 months of therapy with Abbott’s Niaspan(niacin extended-release tablets) plus a statin, the study’s primary endpoint.
In a pre-specified secondary endpoint of the study, treatment with Niaspan plus statin also resulted in significantly fewer major adverse cardiac events, as compared to ezetimibe plus a statin.
Niaspan is not indicated to promote regression of atherosclerosis in combination with a statin.
ARBITER 6 – HALTS is a prospective, randomised, 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 100mg/dL and HDL less than 50 for men or 55mg/dL for women receiving chronic statin therapy. Baseline mean HDL in the study was 43mg/dL and mean LDL was 82mg/dL. At the time of the pre-specified interim analysis, the 208 patients who completed treatment and final imaging were included in the analysis.
This 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 Niaspanto a statin versus LDL-lowering with the addition of ezetimibe.
There were four secondary endpoints like change in lipid values as a composite endpoint consisting of MACE, drug discontinuation due to adverse effects and health-related quality of life.
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.
Eugene Sun, vice president of global pharmaceutical development at Abbott, said: “The ARBITER 6 – HALTS study is the first study showing that HDL-raising with Abbott’s Niaspanon top of statin regresses atherosclerosis compared to an LDL-lowering strategy. These data reinforce the importance of looking beyond LDL treatment targets to address other lipid parameters.”