| ARBITER 6-HALTS: A Surprise Knockout |
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| Posted by Dr. Johanne Perez M.D |
| Wednesday, 18 November 2009 16:55 |
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Niacin's clear win over ezetimibe as an adjunct to statin therapy challenges assumptions about lipid management.
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. — Harlan M. Krumholz, MD, SM Published in Journal Watch Cardiology November 15, 2009
Citation(s): |
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.