Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
In Reply: In response to Dr Kaisers and colleagues,
there had been only 2 other large published studies of inhaled nitric oxide
in patients with ARDS.1,2 The
first of these studies was halted early. It enrolled only patients who increased
their oxygenation status when challenged with inhaled nitric oxide prior to
enrollment. In that trial, the number of patients with improved signs of acute
lung injury was not statistically different between the 2 treatment groups,
the primary end point of the trial. The design of our 2 trials was different
in that all patients were randomized and response status was not established.
Our first study was a phase 2 study that was designed to ascertain safety
and potentially link a dose effect to clinical outcome in patients with ARDS.
A post-hoc analysis suggested that there was a clinical benefit of inhaled
nitric oxide at 5 ppm among this group of patients. To test this hypothesis,
our phase 3 study was completed, which we believe was appropriate and needed.
Dellinger RP, Taylor RW, Zimmerman JL, Straube RC. Inhaled Nitric Oxide in Acute Lung Injury—Reply. JAMA. 2004;292(3):327. doi:10.1001/jama.292.3.327-b