What is the role of Vonoprazon (proton pump inhibitor) in the treatment of peptic ulcer disease in children?

Role of Vonoprazan in Pediatric Peptic Ulcer Disease

Vonoprazan should not be used as first-line therapy for peptic ulcer disease in children due to lack of pediatric-specific safety and efficacy data, higher costs, and limited availability. 1, 2

Current Evidence and Recommendations

The American Gastroenterological Association (AGA) clinical practice guidelines specifically recommend against using potassium-competitive acid blockers (P-CABs) like vonoprazan as first-line therapy for peptic ulcer disease (PUD) treatment or prophylaxis 1. This recommendation applies even more strongly to the pediatric population, where safety data is extremely limited.

Efficacy in Adults

In adult studies, vonoprazan has shown:

• Noninferiority to lansoprazole for gastric ulcer healing (94% vs 94%) 1, 3
• Noninferiority to lansoprazole for duodenal ulcer healing (96% vs 98%) 1, 3
• Similar efficacy to PPIs for artificial ulcers after endoscopic procedures 4, 5

Pediatric Considerations

The 2013 American Academy of Pediatrics guidelines for gastroesophageal reflux management in children do not mention vonoprazan, as it was not widely available at that time 1. These guidelines emphasize caution even with established acid suppressants like PPIs in children, noting:

• Concerns about overuse of PPIs in infants and children 1
• Potential increased risk of lower respiratory tract infections with acid suppression 1
• Risk of community-acquired pneumonia, gastroenteritis, and other infections with acid suppression therapy 1

Potential Niche Applications in Pediatric PUD

While not recommended as first-line therapy, vonoprazan might be considered in specific pediatric scenarios:

1. PPI Treatment Failures: For children with PUD refractory to standard PPI therapy, vonoprazan might be considered as a second-line option 1, 2

2. H. pylori Eradication: In regions with high clarithromycin resistance, vonoprazan-based regimens have shown superior H. pylori eradication rates compared to PPI-based regimens in adults (92% vs 80%) 1, 2. This might be relevant for adolescents with H. pylori-associated PUD who have failed standard therapy.

3. Severe Ulcer Cases: For severe or complicated PUD cases where rapid and potent acid suppression is critical 1

Pharmacological Advantages and Disadvantages

Advantages of Vonoprazan

• Does not require activation in acidic environment (unlike PPIs) 2
• Not metabolized by CYP2C19, leading to less variability in therapeutic outcomes 2, 6
• More rapid onset of action and longer duration of effect 1, 6

Disadvantages and Safety Concerns

• Elevates serum gastrin levels higher than PPIs 2, 6
• Common adverse events include constipation and diarrhea (8-17% incidence) 2, 6
• Limited long-term safety data, especially in children 1, 2
• Higher cost compared to established PPIs 1, 2

Clinical Algorithm for Considering Vonoprazan in Pediatric PUD

1. First-line therapy: Standard PPI therapy at appropriate pediatric dosing
2. Assessment of response: Evaluate after 4-8 weeks of PPI therapy
3. Consider vonoprazan only if:
   • Documented PPI failure despite adequate dosing and compliance
   • H. pylori eradication failure with standard regimens
   • Severe or complicated PUD requiring rapid and potent acid suppression
4. Monitoring if vonoprazan is used:
   • Regular assessment of symptoms and healing
   • Monitor for adverse effects (particularly GI symptoms)
   • Consider serum electrolyte monitoring (potassium, magnesium, calcium)
   • Limit duration of therapy to minimize potential long-term effects

Conclusion

The current evidence does not support vonoprazan as first-line therapy for pediatric PUD. Standard PPIs remain the preferred acid-suppressive therapy for children with PUD, with vonoprazan potentially reserved for specific cases of treatment failure or H. pylori eradication. More pediatric-specific research is needed before broader recommendations can be made for vonoprazan use in children.