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Fluticasone vs. Esomeprazole for Esophageal Eosinophilia

P =0.102

P =0.174

100

Table 1. Baseline patient characteristics

Fluticasone ( n =21)

Esomeprazole ( n =21)

Variables

P value

Mean age±s.d., years

37.0±11.1

38.0±8.8

0.771

Male, n (%)

19 (90.5)

1.000

Race, n (%)

0.766

Caucasian

17 (81.0)

—

Hispanic

3 (14.3)

2 (9.5)

—

African American

1 (4.7)

2 (9.5)

—

Coexisting allergies, n (%) Any atopic disease

Before After Esomeprazole ( n =21)

Before

After

Fluticasone ( n =21)

11 (52.4)

15 (71.4)

0.341

Seasonal allergies

7 (33.3)

1.000

Figure 1. There was no significant change in eosinophil count post treat- ment in either arm regardless of coexisting gastroesophageal reflux disease (GERD). Dashed lines indicate GERD-positive patients.

Asthma

2 (9.5)

1.000

Eczema

2 (9.5)

0 (0.0)

0.488

Food allergies

3 (14.3)

9 (42.9)

0.085

To further explore the relationshipbetween reflux andeosinophilia, we examined the association between impedance reflux episodes and eosinophil counts. There was no significant association between impedance reflux episodes and eosinophil counts in the proximal ( r s =0.263, P =0.116) or distal esophagus ( r s =0.162, P =0.359). In both treatment arms, adherence to therapy was very good. There was no significant difference in adherence to treatment in both groups (FP=86±24% vs. ESO=92±10%, P =0.977). Two patients randomized to the FP arm discontinued treatment during the study period. One patient had worsening of migraine headaches, which he attributed to FP. Another patient had bother- some GERD-related symptoms and discontinued the steroid, and began treatment with a PPIs. Both patients were analyzed as inten- tion to treat. One patient in the fluticasone arm developed esopha- geal candidiasis. He was asymptomatic during the study period and this was discovered on follow-up endoscopy and confirmed on esophageal biopsies. He was treated with a course of oral fluco- nazole. No adverse events occurred in the PPI arm. DISCUSSION This randomized controlled single-blinded study demonstrated a similar histological response between esomeprazole and flutica- sone treatment groups in patients with esophageal eosinophilia. With regard to clinical improvement, based on a validated symp- tom questionnaire, ESO was significantly better than FP regard- less of a concomitant GERD diagnosis. We defined our patient population who had clinical symptoms of esophageal dysfunction and elevated eosinophil counts on biop- sies as having esophageal eosinophilia rather than EoE, based on the most recent updated consensus statement (2). Although swal- lowed FP is commonly accepted as the first-line treatment for EoE, in this study we examined its efficacy in patients who had pheno- typic appearance of EoE and elevated eosinophil counts yet were PPI naive. Our data demonstrated a 19% histological response in patients treated with FP.

Concomitant use of allergy medications, n (%) Antihistamines 4 (19.0)

1.000

4 (19.0)

Nasal steroid spray

3 (14.3)

1 (4.7)

0.606

Leukotriene antagonist

1 (4.7)

1.000

GERD by pH score

4 (19.0)

1.000

3 (14.3)

4 (19.0)

1.000

Erosive esophagitis a

pH reflux episodes No. of episodes

45.8±40.6

25.5±19.3

0.045

% ( x / n ) abnormal patients

28.5% (6/21) 9.5% (2/21)

0.238

Impedance reflux episodes No. of episodes

63.6±23.1

44.8±21.4

0.012

% ( x / n ) abnormal patients

38% (8/21)

14.2% (3/21) 0.159

Mayo dysphagia score

17.1±17.8

19.5±20.7

0.691

Pretreatment eosinophil count Proximal biopsy

39.1±33.2

32.9±19.4

0.473

Distal biopsy

38.4±22.3

34.2±25.2

0.593

GERD, gastroesophageal reflux disease. a All cases of erosive esophagitis were Los Angeles Grade A.

With regard to resolution of endoscopic findings, no signifi- cant difference was seen between FP and ESO ( Table 2 ). Dilation was performed on 15 patients on index endoscopy pri- marily for a dominant stricture seen or a coexisting Schatzki ring (8 patients taking FP and 7 patients taking ESO). No dilations were performed during the treatment period or on follow-up endos- copy post therapy. There was significant improvement in clinical symptoms based on a mean decrease in the MDQ score seen in both treatment groups who underwent dilation (FP= −10.6±10.5, P =0.027 and ESO= −14.3±14.0, P =0.027). Among patients who did not undergo dilation ( n =27) on index endoscopy, there was a significant decrease in MDQ score in the ESO group (−20±24, P =0.005) but not in the FP group (−1.9±21.5, P =0.721).

The American Journal of GASTROENTEROLOGY

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