What is the recommended use and dosage of Vonoprazan (Vonoprazan) for treating acid-related diseases such as Gastroesophageal Reflux Disease (GERD) and Peptic Ulcer Disease (PUD)?

Vonoprazan for Acid-Related Diseases: Recommended Use and Dosage

Vonoprazan should generally not be used as first-line therapy for GERD or peptic ulcer disease but should be reserved for patients who fail twice-daily PPI therapy. 1

Recommended Dosing

• For erosive esophagitis treatment: Vonoprazan 20 mg once daily 1, 2
• For maintenance of healed erosive esophagitis: Vonoprazan 10 mg once daily 1, 2
• For non-erosive GERD: Vonoprazan 10 mg once daily 2
• For peptic ulcer disease: Vonoprazan 20 mg once daily 1
• For ulcer prophylaxis in patients on low-dose aspirin or NSAIDs with history of PUD: Vonoprazan 10-20 mg once daily 1

Treatment Algorithm for GERD

1. First-line therapy: Standard PPI therapy 1
2. Second-line therapy: Escalate to twice-daily PPI if inadequate response 1
3. Third-line therapy: Consider vonoprazan 20 mg daily only after failure of twice-daily PPI therapy 1

Treatment Algorithm for Peptic Ulcer Disease

1. First-line therapy: Standard PPI therapy 1
2. Second-line therapy: Vonoprazan 20 mg daily for PPI treatment failures 1
3. Special consideration: Vonoprazan may be considered first-line for high-risk ulcer bleeding cases due to its rapid and potent acid inhibition 1

Clinical Efficacy

• Vonoprazan 20 mg is comparable to lansoprazole 30 mg for gastric ulcer healing (94% vs 94% at 8 weeks) and duodenal ulcers (96% vs 98% at 6 weeks) 1
• Vonoprazan demonstrates superior efficacy for maintenance of healing in severe erosive esophagitis (LA grade C/D) compared to lansoprazole, with healing rates of 75-77% vs 62% 1
• For PPI-resistant erosive esophagitis, vonoprazan 20 mg shows healing rates of 91.7% at 4 weeks and 88.5% at 8 weeks 3
• Maintenance rates for healed PPI-resistant erosive esophagitis with vonoprazan 10 mg are 82.6% at week 8,86.0% at week 24, and 93.8% at week 48 3

Pharmacokinetic Considerations

• Vonoprazan reaches steady state concentrations by Day 3-4 2
• Food has minimal effect on absorption (5% increase in Cmax, 15% increase in AUC) 2
• Dosage adjustments are needed for patients with:
  • Severe renal impairment (eGFR 15 to <30 mL/min/1.73 m²): Systemic exposure increases 2.4-fold 2
  • Moderate to severe hepatic impairment (Child-Pugh Class B or C): Systemic exposure increases 2.4-2.6 fold 2

Advantages Over Traditional PPIs

• Vonoprazan demonstrates superior and more consistent acid suppression than PPIs 4
• It provides rapid and sustained symptom relief and mucosal healing 4
• Particularly effective for PPI-resistant GERD, with symptom improvement rates of 88% 5
• More effective for erosive GERD (100% improvement) than non-erosive GERD (83% improvement) 5

Common Pitfalls to Avoid

• Avoid using vonoprazan as first-line therapy for mild GERD or PUD when PPIs would be more cost-effective 1
• Consider cost implications as vonoprazan is significantly more expensive than standard and double-dose PPIs in the United States 1
• Monitor gastrin levels as vonoprazan causes elevated serum gastrin levels during treatment (levels return to normal within 4 weeks after discontinuation) 2
• Be aware of potential false positive results in diagnostic investigations for neuroendocrine tumors due to increased CgA levels caused by vonoprazan 2
• Consider limited long-term safety data compared to PPIs, though short-term safety appears comparable 1

Special Populations

• Vonoprazan is particularly effective for H. pylori-associated ulcers compared to idiopathic or NSAID-related ulcers 1
• No clinically meaningful differences in pharmacokinetics are predicted in patients 65 years of age and older 2
• No clinically significant differences in pharmacokinetics based on sex or race/ethnicity 2