(Circulation. 1998;98:1829-1830.)
© 1998 American Heart Association, Inc.
Cardiovascular News |
Safety and Effectiveness of Inhaled Nitric Oxide and Tirofiban for Acute Coronary Syndromes
A Report From the Cardiovascular and Renal Advisory Panel of the Food and Drug Administration
Correspondence to JoAnn Lindenfeld, MD, University of Colorado Health Sciences Center, Campus Box B-130, 4200 E Ninth Ave, Denver, CO 80262.
The Cardiovascular and Renal Advisory Panel of the Food and Drug Administration (FDA) met April 9 to 10, 1998, to discuss the safety and effectiveness of inhaled nitric oxide and the platelet IIb/IIIa inhibitor tirofiban.
Inhaled Nitric Oxide
Because there are currently a large number of individual
investigator Investigational New Drug studies (INDs) for the use
of inhaled nitric oxide (INO) in both neonates and adults, the panel
met to review what is known about the safety and effectiveness of INO,
to discuss the need for further clinical trials, and to consider the
goals and designs of any future trials. The panel had recommended in
1995 that the efficacy of INO should be measured by clinical outcomes
such as death, use of extracorporeal membrane
oxygenation (ECMO), neurological status, and
bronchopulmonary dysplasia rather than by improvements in
systemic oxygenation. At the last meeting, it was
generally agreed that similar standards for drug approval should be
used in children and adults, although studies using only mortality as
an outcome may currently not be feasible in children on the basis of
both the large number needed for a definitive mortality trial and
current practice. However, the committee thought that mortality should
be included as an outcome along with the use of ECMO and measures of
neurological status and bronchopulmonary dysplasia. Trials were
presented that showed a marked improvement in
oxygenation in the majority of neonates with hypoxic
respiratory failure but no benefit on mortality. Although there was a
decrease in the use of ECMO in the