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In Reply: The letters by Dr Burger and by Drs Gortney and Porter raise concerns about imbalances between groups in VMAC.¹ Although some of these may be relevant, with 19 comparisons made in baseline characteristics in VMAC, it is not surprising that there would be differences noted. However, our analysis accounts for differences in the use of dobutamine as a concomitant therapy within VMAC, where its use was not a significant predictor of survival. Dobutamine was not permitted during the placebo-controlled phase of either PROACTION or NSGET.²

Analyzing only patients who did not receive inotropic agents, as suggested by Burger, would introduce bias, since patients who received an inotrope are different from those who did not. Nevertheless, even after eliminating all patients in VMAC who received dobutamine (the inotrope identified explicitly in the FDA files), patients in VMAC randomized to nesiritide remained at higher risk of death (21 deaths in . . . [Full Text of this Article]

Jonathan D. Sackner-Bernstein, MD
jonathansb@yahoo.com
Division of Cardiology
North Shore University Hospital
Manhasset, NY

Keith Aaronson, MD, MS
Division of Cardiovascular Medicine
University of Michigan
Ann Arbor

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