INDIANAPOLIS, Feb. 29 -- Swallowed fluticasone spray (Flovent) may be a better choice for allergic eosinophilic esophagitis in children, researchers here said.
Fluticasone and oral prednisone were equally effective in reducing symptoms of the disease, but fewer side effects were seen with fluticasone, reported Sandeep K. Gupta, M.D., of Indiana University School of Medicine and Riley Hospital for Children, in the February issue of Clinical Gastroenterology and Hepatology.
Action Points
- Explain to interested patients that the study found swallowed fluticasone spray eliminated symptoms of eosinophilic esophagitis in most children and was less likely to cause adverse effects than oral prednisone.
- Point out that fluticasone is not approved for this indication.
- Point out that long-term effects of swallowed fluticasone have not been studied in this population.
Their study is the first randomized, head-to-head comparison of different steroid formulations in eosinophilic esophagitis, the researchers said.
Dr. Gupta said in an interview that he now prescribes inhaled fluticasone -- approved only for treatment of asthma -- as first-line drug treatment for eosinophilic esophagitis, when dietary modifications are not effective.
Eosinophilic esophagitis is increasingly seen as a cause of discomfort, food impaction, recurrent vomiting, and refusal to eat. The symptoms are similar to gastroesophageal reflux but it is marked by substantially higher eosinophil counts in the esophageal epithelium.
Since the condition was first recognized as a distinct entity in the 1990s, most patients have been treated with oral or topical steroids in addition to dietary modifications.
Dr. Gupta and colleagues recruited 80 children (mean age 7.1) and assigned them to receive either oral prednisone at 1 mg/kg twice daily, to a maximum of 30 mg per dose, or fluticasone spray.
The fluticasone was delivered via a metered-dose inhaler, but the children were told to swallow the medication rather than inhale it.
Patients received two puffs four times a day, with 110 micrograms per puff for children less than 11 years old and 220 micrograms per puff for those 11 or older.
Treatment lasted four weeks. Patients were then weaned from the drugs over an eight-week period, and followed for an additional 12 weeks.
All participants underwent food allergy testing at baseline, with about 58% showing positive responses. Those patients were encouraged to avoid foods identified as allergenic.
At the end of the full-dose treatment period, all 32 evaluable patients in the prednisone arm and 35 of 36 evaluable patients receiving fluticasone were symptom-free.
Histologic improvement was seen in 30 of 32 children receiving prednisone and in 34 of 36 patients in the fluticasone group. The degree of improvement was greater with prednisone (P=0.044).
None of the patients on fluticasone experienced systemic adverse effects. Symptoms such as hyperphagia, weight gain, and development of cushingoid features occurred in 40% of the prednisone group.
Candidal overgrowth in the esophagus was seen in 15% of patients receiving fluticasone, with complete resolution by week 4. None of the patients in the prednisone group had this problem.
At week 18, six weeks after discontinuing treatment, 36% of patients in the prednisone group and 22% of those receiving fluticasone again showed symptoms of eosinophilic esophagitis. By week 24, about 45% of patients in both groups had symptom recurrence.
Among those with symptom recurrence, mean time to relapse was 5.5 weeks (SD 4.0) in the prednisone group and 8 weeks (SD 6.1) in the fluticasone group.
The researchers said their results were generally in keeping with earlier studies of the two drugs individually.
They cited as limitations the lack of a double-blind design and placebo control, reliance on patient diaries for symptom assessment, and the use of allergy testing and food elimination in addition to the study drugs.
The latter did not appear to confound the results, the researchers said, since there was no difference in relapse rates between participants with positive and negative allergy test results.
Dr. Gupta said it would be important to conduct longer-term studies. In particular, the chronic effects of swallowed fluticasone need to be researched more fully, he said.
Another need is to identify the best maintenance protocols, in view of the high relapse rate following full medication withdrawal, the researchers said.
| The study was supported by Clarian Health Partners Inc.
No potential conflicts of interest were disclosed. |
Secondary Source
Clinical Gastroenterology and Hepatology
Schaefer E, et al Clinical Gastroenterology and Hepatology 2008; 6: 165-73.