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To the Editor: We commend Dr Hulley and colleagues¹ on a well-designed, first-ever randomized trial to evaluate continuous estrogen-progestin hormone replacement therapy (HRT) for the secondary prevention of coronary heart disease (CHD). Surprisingly and disturbingly, the results do not support the beneficial effects of HRT found in observational studies.

Despite the appropriate randomization, blinding, and intention-to-treat analysis, we are concerned that, during the trial, subjects in the control and HRT groups were differently exposed to agents that could affect the primary study outcomes. For example, the authors noted that more women in the control group began treatment with lipid-lowering agents (primarily statins) during the trial, and they astutely adjusted for low-density lipoprotein levels during their analysis. However, since statin use over an average of 5 years decreases coronary events and coronary deaths in patients with CHD who have high and normal cholesterol levels,^2-4 this differential utilization could still bias the . . . [Full Text of this Article]