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ARBITER 6-HALTS: A Surprise Knockout
Niacin's clear win over ezetimibe as an adjunct to statin therapy challenges assumptions about lipid management.
To compare the effects of niacin versus ezetimibe when added to statin treatment, investigators conducted a randomized, open-label trial with blinded adjudication of endpoints. All patients were already taking a statin and had LDL levels <100 mg/dL, HDL levels <55 mg/dL, and coronary heart disease or a risk equivalent (e.g., diabetes or a 10-year Framingham risk score of 
20%). The primary endpoint was change in carotid intima–media thickness (CIMT) after 14 months. The industry-funded, investigator-initiated trial was terminated early on the basis of results from a prespecified interim analysis.
A total of 208 participants (mean age, 65; 80% men) had 14-month endpoint data. At baseline, mean levels of LDL and HDL were 82 mg/dL and 42 mg/dL, respectively. At 14 months, the mean LDL level had decreased by 18 mg/dL in the ezetimibe group and by 10 mg/dL in the niacin group. The mean HDL level decreased by 3 mg/dL in the ezetimibe group and increased by 8 mg/dL in the niacin group.
Niacin, but not ezetimibe, was associated with a significant reduction in CIMT thickness. In the ezetimibe group, paradoxically, greater decreases in LDL levels were associated with greater increases in CIMT thickness. The rate of major cardiovascular events was higher in the ezetimibe group than in the niacin group (5% vs. 1%; P=0.04).
Comment: In this small trial, niacin was superior to ezetimibe in high-risk patients on statin monotherapy. These findings do not deliver a final verdict on ezetimibe. (Nor do they prove that the niacin-statin combination confers clinical benefit beyond statin monotherapy in this patient population.) However, they add to concerns about a medication that continues to be quite popular, despite a lack of evidence that its ability to reduce LDL levels translates into patient benefits. Unfortunately, patient-important outcomes of large trials of ezetimibe will not be available for many years. In the meantime, ezetimibe should be a drug of last resort, if it is used at all.
Published in Journal Watch Cardiology November 15, 2009
Citation(s):
Taylor AJ et al. Extended-release niacin or ezetimibe and carotid intima–media thickness. N Engl J Med 2009 Nov 16; 361: [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa0907569)
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- ARBITER 6 Widely Misinterpreted
Eliot A Brinton, University of Utah, 17 Nov 2009 2:08 PM EST
ARBITER 6 gives needed encouragement for use of niacin in patients with low HDL, with and LDL-C already at or... [more] - ARBITER 6-HALTS trial
Ronald E. Habros MD, 18 Nov 2009 10:50 AM EST
Once again an underpowered study using serrogate endpointes. Your wasting our time. Lets wait until we get some real data... [more] - ARBITER 6-HALTS trial
Rudy Robinson, 24 Nov 2009 3:45 PM EST
Has anyone done a trial comparing niacin with statins in the first place? Or is that dangerous for one's career?... [more] - niacin dose
randy k minion, 8 Jan 2010 10:48 AM EST
can anyone get patients up to 2000 mg of Niacin a day as was used in the trial? - This Trial re- opens the 'possibility' for Niacin
Pichakacheri sureshkumar, P.V.S hospital, Kozhikkode, India, 11 Jan 2010 10:53 AM EST
As shown in this trial, I had a strong gut feeling that, ezetimibe either in combination with statin, or alone... [more] - ARBITER 6 zetia vs niacin
LW Martin, 27 Jan 2010 12:13 PM EST
This study looks at CIMT over a year's time in a small group of patients on zetia vs niacin, in... [more]
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