Editorials |
From the Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa.
Correspondence to Lewis H. Kuller, MD, DrPH, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto St, Pittsburgh, PA 15261.
The article by Cheung et al,1 "Antioxidant supplements block the response of HDL to simvastatin-niacin therapy in patients with coronary artery disease and low HDL" in this issue of Arteriosclerosis, Thrombosis, and Vascular Biology, demonstrates a possibly important and troubling observation. The addition of an antioxidant "cocktail," comprising vitamins E and C, ß-carotene, and selenium, for participants on simvastatin and niacin (SNA) therapy, resulted in a significant blunting of the apoA1 and HDL2c response compared with those on lipid-lowering drugs alone (SN). None of the HDL-related changes for the antioxidant group only were different from those for placebo.
See page 1320
The unexplained results in a clinical trial are often chance findings, given the numerous possible analyses. The statistical test of significance is not meaningful in such an analysis because there was no prior hypothesis before the data were reviewed. It is probably better to provide a point estimate of the effect and the confidence limits. The unusual findings should not, however, be swept under the rug because they were not part of the planned analysis. The results should be presented so that other investigators can either substantiate or refute these observations with different data sets. The authors did not provide the results of the clinical trial for the primary end points. At the March 2001 American College of Cardiology meeting, the research group from Seattle (Zhao and colleagues2) presented preliminary results of the trial that showed that the combination of antioxidants and lipid-lowering drugs (SNA) not only
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