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May 16, 2007

Iron Reduction and Cardiovascular Outcomes—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2007;297(19):2075-2076. doi:10.1001/jama.297.19.2076-a

In Reply: Drs Sullivan and Katz identify key limitations of our study, including that it was a secondary prevention trial and that full iron reduction was not achieved. Trade-offs in clinical trial design, including the population selected for intervention, were recognized in planning. New insights on adherence and toxicity from our intent-to-treat analysis should enhance the design of more focused tests of the iron hypothesis in the future.

Dr Allison and colleagues are concerned that “conclusions of the post hoc analyses were misleading” because “age was not described in the initial study plan” and because subgroup analyses have limitations. They did not suggest how age effects should have been described, if at all.

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