Results from the investigator-initiated Arbiter 6 - Halts study showed patients at high cardiovascular risk had significant regression of atherosclerosis after eight 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, (or MACE, a composite endpoint consisting of heart attack, myocardial revascularization, admission to the hospital for an acute coronary syndrome, and death from coronary heart disease), as compared to ezetimibe plus a statin.
The study was stopped early after a pre-specified interim analysis was conducted on 208 patients who had completed treatment and had undergone final ultrasound imaging of the carotid artery to measure the impact of treatment on atherosclerosis. Atherosclerosis is fat build-up in the arteries and in the early stages it can be found inside the lining of the arteries, known as intima media thickness (IMT). Halts measured IMT in the carotid artery.
"The Arbiter 6 - Halts study is the first study showing that HDL-raising with Abbott's Niaspan on top of statin regresses atherosclerosis compared to an LDL-lowering strategy," said Eugene Sun, vice president, Global Pharmaceutical Development, Abbott. "These data reinforce the importance of looking beyond LDL treatment targets to address other lipid parameters."
Niaspan is not indicated to promote regression of atherosclerosis in combination with a statin. In patients taking Niaspan, the most commonly reported adverse event was flushing of the skin, a transient effect associated with niacin therapy. Adverse drug effects were cited as the reason for withdrawal in three ezetimibe patients and 17 niacin patients. The difference between treatment groups was not statistically significant.
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.