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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.

We did not prejudge age effects in study design because our purpose was not to prove an interaction between age and iron reduction. Patients older than 21 years were eligible for entry, and age was a prespecified . . . [Full Text of this Article]

Leo R. Zacharski, MD
leo.r.zacharski@dartmouth.edu
Research Service
Department of Veterans Affairs Medical Center
White River Junction, Vt

Bruce K. Chow, MS
Research Service
Department of Veterans Affairs Medical Center
Palo Alto, Calif

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RELATED LETTERS

Iron Reduction and Cardiovascular Outcomes
Jerome L. Sullivan and Stuart D. Katz
JAMA. 2007;297(19):2075.
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Iron Reduction and Cardiovascular Outcomes
Robert D. Allison, Barbara J. Bryant, Sumithira Vasu, and Susan F. Leitman
JAMA. 2007;297(19):2075-2076.
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Reduction of Iron Stores and Cardiovascular Outcomes in Patients With Peripheral Arterial Disease: A Randomized Controlled Trial
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