Oral Viscous Budesonide for Treatment of Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) has been increasingly recognized as a cause of food impactions and dysphagia. Short-term treatment goals include symptomatic and histological improvement, with the prevention of fibrostenosis the primary long-term goal. Topical steroids are first-line treatment agents for EoE. In a study cohort of 75 EoE patients at Walter Reed National Military Medical Center, with a median age of 33 years (range 2-64 years), overall histologic response rate to topical steroids was 51%, while 71% improved clinically. Reed et al. of the Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine noted that because no commercially available medications exist for the treatment of EoE, patients must use off-label or compounded medications.
The efficacy of a compounded budesonide suspension was assessed in a retrospective cohort study of 48 EoE patients (mean age 33.6; 69% male). After a mean length of follow-up of 17 months, there was a significant decrease in symptoms of dysphagia (95% vs. 32%), improvements in heartburn (37% vs. 11%) and global symptom response (81%). The median of the peak eosinophil counts decreased from 55 to 20 eos/hpf with 42% achieving a response of <15 eos/hpf. Esophageal candidiasis was rare (6%). In the 18 patients with prior non-response to corticosteroids or dietary elimination, 83% had symptomatic and 38% had histologic response. Compounded budesonide suspension produced a durable symptomatic, endoscopic, and histologic response in a cohort followed for more than a year. Many patients previously refractory to prior therapy responded to compounded budesonide.
Also at the University of North Carolina School of Medicine, a randomized clinical trial assessed whether oral viscous budesonide (OVB) was more effective than fluticasone MDI for initial treatment of patients with EoE. Patients with a new diagnosis of EoE were randomly assigned to groups given 8 weeks of either OVB (1 mg/4 mL) twice daily plus a placebo inhaler (n = 56) or fluticasone MDI (880 µg) twice daily plus a placebo slurry (n = 55). The subjects had baseline peak eosinophil counts of 73 and 77 eos/hpf in the OVB and MDI groups, respectively. Post-treatment eosinophil counts were 15 and 21 in the OVB and fluticasone MDI groups, respectively, with 71% and 64% achieving histologic response. Esophageal candidiasis developed in 12% of patients receiving OVB and 16% receiving fluticasone MDI; oral thrush was observed in 3% and 2%, respectively.
Aakash Goyal, MD, Assistant Professor in the Department of Pediatrics at UT Southwestern Medical Center, Dallas, who provides medical care at Children’s Medical Center Dallas, found that oral viscous budesonide (OVB) which has mucoadhesive properties, has been more effective than a fluticasone inhaler in achieving remission of EoE.
Maintenance therapy at a reduced dosage is typically required because relapse is common after discontinuation of therapy.
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Compounded Oral Viscous Budesonide is Effective and Provides a Durable Response in Eosinophilic Esophagitis
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A 12-Week Maintenance Therapy with a New Prepared Viscous Budesonide in Pediatric Eosinophilic Esophagitis
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Oral Viscous Budesonide (OVB) for Treatment of Eosinophilic Esophagitis
The treatment of EoE and GERD differs, it is important to distinguish between them. Swallowed topical steroids, such as fluticasone propionate, have been administered using a metered-dose inhaler (MDI) without a spacer, with instructions to not inhale, but to puff and swallow, thus delivering a topical antiinflammatory product to the esophageal mucosa. Although effective in lowering eosinophil levels, this technique of administering aerosolized corticosteroids, which are often bitter to taste, may be complicated for young children, and twice daily administration is necessary. However, this treatment is attractive because only 1% of the steroid is absorbed systemically and it undergoes rapid hepatic processing. The main potential side effect is oral/esophageal Candida infection that developed in 3 of 20 patients in one series.
- Budesonide is a corticosteroid with high topical anti-inflammatory activity but low systemic activity due to extensive hepatic metabolism. Aceves et al. of Children’s Hospital and the Department of Pediatrics, University of California, San Diego, reported the successful treatment of EoE using an oral viscous suspension of budesonide in 2 patients who were unable to utilize fluticasone propionate for developmental reasons.
- Researchers noted: “Our data suggest that OVB is an effective and safe treatment for young children with proven EoE. It may have advantages over other therapies in that it is palatable, its volume (8–12 ml) provides pan-esophageal mucosal coverage, and it requires only once daily administration.” The increased viscosity of OVB may prolong budesonide’s contact time with the esophageal mucosa. No significant adverse events were reported. Morning cortisol levels were within normal limits.
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