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CLINICAL NEWS
87.1% vs. 78.2%, respectively; p values
not reported). However, the following
AEs were more frequently reported in the
L-glutamine group: low-grade nausea,
fatigue, noncardiac chest pain, and mus-
culoskeletal pain (p values not reported).
Two patients died during treatment with
L-glutamine, but the authors noted that
both of these patients presented with a
prolonged history of organ failure and
additional co-existing medical conditions
that may have contributed to mortality.
The benefits of oral L-glutamine pow-
der were seen regardless of hydroxyurea
use, the authors reported, with a consistent
treatment effect across subgroups; the rate
ratio (i.e., the ratio of the recurrent event
rates in each trial group) was 0.77 for par-
ticipants with prior hydroxyurea use and
0.78 for those without hydroxyurea use (p
value not reported).
These findings also suggest that the
effect of L-glutamine may be additive
to hydroxyurea therapy, the researchers
concluded, “to lower the incidence of pain
crises for those who may have suboptimal
response to hydroxyurea.”
The results from this phase III trial sup-
ported the U.S. Food and Drug Administra-
tion’s approval of oral L-glutamine powder
to reduce the acute complications of SCD in
children and adults. However, the authors
noted that, because the maximum age of
In the INO-VATE ALL study