From the Guidelines
Vonoprazan is recommended at a dose of 20 mg once daily for the treatment of GERD and peptic ulcer disease, with therapy duration of 4-8 weeks for healing erosive esophagitis and gastric ulcers, and 4 weeks for duodenal ulcers, as supported by the most recent study 1. The treatment regimen for vonoprazan in patients with acid-related diseases such as Gastroesophageal Reflux Disease (GERD) and Peptic Ulcer Disease (PUD) should be based on the latest clinical practice updates.
- For GERD, vonoprazan is typically prescribed at 20 mg once daily, with a therapy duration of 4-8 weeks for healing erosive esophagitis, followed by maintenance therapy of 10-20 mg daily for patients requiring long-term acid suppression 1.
- For peptic ulcer disease, the standard regimen is 20 mg once daily for 4-8 weeks for gastric ulcers and 4 weeks for duodenal ulcers, as demonstrated by a Japanese randomized trial that showed the noninferiority of vonoprazan 20 mg compared with lansoprazole 30 mg once daily after breakfast for gastric ulcer healing and duodenal ulcers 1. Key considerations for the use of vonoprazan include:
- The medication should be taken without regard to meals.
- Patients should be monitored for potential side effects including headache, constipation, and diarrhea.
- Dose adjustments may be necessary for patients with severe hepatic impairment, though no adjustment is typically needed for renal impairment. It is essential to note that while vonoprazan offers advantages over traditional PPIs, its use as first-line therapy is generally not recommended due to higher costs and limited availability, as stated in the clinical practice update 1. However, vonoprazan may be useful in PPI treatment failures of ulcers, assuming such ulcers are not secondary to processes that can cause ulcers even without acid.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Treatment Regimen for Vonoprazan
The recommended treatment regimen for vonoprazan in patients with acid-related diseases such as Gastroesophageal Reflux Disease (GERD) and Peptic Ulcer Disease (PUD) is as follows:
- For GERD, vonoprazan has been shown to be effective in healing and maintaining healing of erosive esophagitis, as well as relieving heartburn in adult patients with erosive esophagitis and non-erosive GERD 2.
- The typical dosage of vonoprazan for GERD is 20 mg once daily, with no requirement to be taken in relation to timing of meals for optimal efficacy 2.
- For PPI-resistant GERD, vonoprazan has been shown to have high efficacy in healing and maintaining healing of erosive esophagitis, with healing rates of 91.7% and 88.5% at weeks 4 and 8, respectively 3.
- For peptic ulcer disease, vonoprazan has been shown to be effective in healing gastric ulcers, with a healing rate of more than 90% 4.
Efficacy and Safety of Vonoprazan
The efficacy and safety of vonoprazan have been evaluated in several studies, including:
- A comprehensive review of clinical trials and studies, which found that vonoprazan demonstrates superior and more consistent acid suppression than PPIs, resulting in rapid and sustained symptom relief and mucosal healing 5.
- A systematic review and meta-analysis, which found that vonoprazan has high efficacy in the healing and maintenance of PPI-resistant erosive esophagitis, and moderate efficacy for the improvement of symptoms in non-erosive reflux disease 3.
- A study, which found that vonoprazan is generally well tolerated, with the most common adverse events including abdominal pain, constipation, diarrhea, nausea, and dyspepsia 2.
Comparison to Proton Pump Inhibitors (PPIs)
Vonoprazan has been compared to PPIs in several studies, including:
- A study, which found that vonoprazan provides more potent gastric acid suppression, more effective esophageal acid exposure control, enhanced symptom improvement, and better esophagitis healing than PPIs in patients with PPI-refractory GERD 6.
- A review, which found that vonoprazan has a favorable safety profile, with fewer adverse effects and drug interactions compared to PPIs 5.