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The
American Journal
of
GASTROENTEROLOGY
nature publishing group
INTRODUCTION
Eosinophilic esophagitis (EoE) is a chronic inflammatory
immune-mediated condition characterized by symptoms of
esophageal dysfunction and the presence of dense eosinophilia
on esophageal biopsies (1). Management, most often with topical
steroids, is aimed at improving clinical symptoms and reversing
the inflammatory changes within the esophagus to prevent tissue
remodeling and formation of fibrosis (2).
Randomized Controlled Trial Comparing Aerosolized
Swallowed Fluticasone to Esomeprazole for Esophageal
Eosinophilia
Fouad J. Moawad, MD
1,2
, Ganesh R. Veerappan, MD
1,2
, Johnny A. Dias, DO
1
, Thomas P. Baker, MD
3
, Corinne L. Maydonovitch, BS
1
and Roy K.H. Wong, MD
1,2
OBJECTIVES:
Patients with clinical symptoms of esophageal dysfunction and dense eosinophilic infiltration of the
esophageal mucosa are suspected to have eosinophilic esophagitis (EoE). Topical steroids are often
used as first-line therapy for EoE, although some patients respond clinically to proton pump inhibitors
(PPIs). The purpose of this study was to compare the histological and clinical response of patients with
esophageal eosinophilia treated with aerosolized swallowed fluticasone propionate vs. esomeprazole.
METHODS:
This prospective single-blinded randomized controlled trial enrolled newly diagnosed patients with
suspected EoE, defined as having clinical symptoms related to esophageal dysfunction with at least
15eosinophils/high power field (hpf). Patients underwent 24-h pH/impedance monitoring to establish gas-
troesophageal reflux disease (GERD). Patients were stratified by the presence of GERD and randomized to
receive fluticasone 440mcg twice daily or esomeprazole 40mg once daily for 8 weeks followed by repeat
endoscopy with biopsies. The primary outcome was histological response of esophageal eosinophilia, de-
fined as <7eosinophils/hpf. Secondary outcomes included clinical change in symptoms using the validat-
ed Mayo dysphagia questionnaire (MDQ) and interval change in endoscopic findings following treatment.
RESULTS:
Forty-two patients (90% male, 81% white, mean age 38±10 years) were randomized into fluticasone
(
n
=21) and esomeprazole (
n
=21) treatment arms. In all, 19% (8/42) of patients had coexisting
GERD and were equally stratified into each arm (
n
=4). Overall, there was no significant difference in
resolution of esophageal eosinophilia between fluticasone and esomeprazole (19 vs. 33%,
P
=0.484).
In patients with established GERD, resolution of esophageal eosinophilia was noted in 0% (0/4) of
the fluticasone group compared with 100% (4/4) of the esomeprazole group (
P
=0.029). In GERD-
negative patients, there was no significant difference in resolution of esophageal eosinophilia between
treatment arms with fluticasone and esomeprazole (24 vs.18%,
P
=1.00). The MDQ score signifi-
cantly decreased after treatment with esomeprazole (19±21 vs. 1.4±4.5,
P
<0.001), but not with
fluticasone (17±18 vs. 12±16,
P
=0.162). Improvement in endoscopic findings and other histological
markers were similar between treatment groups.
CONCLUSIONS:
Fluticasone and esomeprazole provide a similar histological response for esophageal eosinophilia.
With regard to clinical response, esomeprazole was superior to fluticasone, particularly in patients
with established GERD.
SUPPLEMENTARY MATERIAL
is linked to the online version of the paper at
http://www.nature.com/ajgAm J Gastroenterol
2013; 108:366–372; doi:10.1038/ajg.2012.443; published online 12 February 2013
1
Department of Medicine, Walter Reed National Military Medical Center, Gastroenterology Service, Bethesda, Maryland, USA;
2
Uniformed Services University
of the Health Sciences, Bethesda, Maryland, USA;
3
Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.
Correspondence:
Fouad J. Moawad, MD, Department of Medicine, Walter Reed National Military Medical Center, Gastroenterology Service, 8901 Rockville Pike,
Bethesda, Maryland 20889, USA. E-mail:
Fouad.Moawad@us.army.milReceived 16 May 2012; accepted 16 September 2012
Reprinted by permission of Am J Gastroenterol. 2013; 108(3):366-372.
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