Congress Reports

ESHonline Coverage, based on selected sessions at the:
American Heart Association 2004 Annual Scientific Sessions
November 7 - 10, 2004, New Orleans, Louisiana

This activity is not sanctioned by, nor a part of, the Americann Heart Association.



 
 


Niacin Plus Statins Slows Atherosclerotic Progression

November 10, 2004 (eshonline.org) - A 68% reduction in carotid artery atherosclerosis, measured as carotid intimal medial thickening, when adding prescription extended-release niacin to statin therapy in patients with coronary heart disease (CHD) on a statin with an LDL-cholesterol < 130 mg/dL and an HDL-cholesterol < 45 mg/dL. No change in this measure was seen in the statin only group. The ARBITER 2 (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol) study was reported today at the 2004 Scientific Sessions of the American Heart Association, and simultaneously published in Circulation . Niacin is known to raise HDL cholesterol in addition to lowering LDL cholesterol and this trial represents increasing recognition that the entire lipid profile, rather than just LDL, must be treated to reduce cardiovascular events. A 60% reduction of coronary events was also found with niacin plus statins compared to statins alone in the 167 study patients, on average 74 years and 68% male.

HDL was increased a significant 21% in the niacin plus statin patients (from 39 to 47 mg/dL). A significant difference between groups in the change in HDL was seen as early as 12 months in this 24-month study. Triglycerides were significantly improved with niacin plus statin versus statin alone at 12 months (134 mg/dL and 164 mg/dL, respectively). A post-hoc analysis comparing patients with diabetes/metabolic syndrome or no diabetes, showed progression in both placebo groups, lowest progression of intimal medial thickness in the niacin plus statin group, and a significantly lower progression in patients without diabetes/metabolic syndrome taking niacin.

Study withdrawal was the same in both groups (9 patients each). There was no increase in liver enzymes above 3x upper limits of normal. Fasting blood glucose increased similarly in both groups. Cutaneous flushing occurred in 13% of the statin only group and 69% of the niacin plus statin group. Study drug adherence was high, ranging from 90.3% and 94.5%, and not different between groups.

This is the first clinical trial to show that the combination of niacin and statin therapy is superior to statin therapy alone, and an incremental benefit of adding extended-release niacin to statin therapy. Niacin plus statin significantly improved HDL, triglycerides, and non-HDL cholesterol, and likely contributes to the observed stabilization of intimal medial thickening. ARBITER 2 provides strong preliminary support for the expanded present clinical use of prescription extended release niacin plus statin therapy for secondary prevention of CHD. The results may forecast the results of future statin-controlled clinical trials of combination therapy with niacin and other investigational agents.

 
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