What is the best next step in management for a patient with persistent heartburn despite Proton Pump Inhibitor (PPI) therapy?

From the Guidelines

For a patient with persistent heartburn despite PPI therapy, the best next step is to perform 24-hour pH/impedance testing on PPI, as recommended by the most recent and highest quality study 1. This approach allows for the determination of the mechanism of persisting esophageal symptoms despite therapy and can help identify the presence of non-acid reflux, which is common in patients with persistent symptoms despite PPI therapy 1. The use of pH/impedance monitoring can also help to diagnose increased acid exposure, association between symptoms and acid or non-acid reflux, and identification of phenotypes such as non-erosive reflux disease, hypersensitive oesophagus, and functional heartburn 1. Key considerations in the management of PPI-refractory heartburn include:

• Optimizing the current PPI regimen by increasing the dose, splitting it to twice daily, or ensuring it's taken 30-60 minutes before meals
• Adding an H2 receptor antagonist, such as famotidine 20-40mg at bedtime, to control nighttime symptoms
• Considering lifestyle modifications, including weight loss, avoiding meals 2-3 hours before bedtime, elevating the head of the bed, and eliminating trigger foods and beverages
• Evaluating for alternative diagnoses, such as functional heartburn, eosinophilic esophagitis, or non-GERD causes like cardiac issues, which may require specific testing such as pH monitoring or impedance testing 1. It is essential to prioritize the single most recent and highest quality study, which in this case is the 2022 AGA clinical practice update on the personalized approach to the evaluation and management of GERD 1.

From the FDA Drug Label

As shown in Table 6, patients treated with Famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo The U. S. trial comparing orally-administered Famotidine 40 mg twice daily to placebo and orally administered Famotidine 20 mg twice daily showed a significantly greater percentage of healing of erosive esophagitis for Famotidine 40 mg tablets twice daily at Weeks 6 and 12

The best next step in management for a patient with persistent heartburn despite Proton Pump Inhibitor (PPI) therapy is B) 24-hour pH/impedance testing on PPI. This is because the patient has already failed a 2-month trial of PPI twice daily, and further evaluation is needed to determine the cause of persistent symptoms. The provided drug label information does not directly address the management of patients with persistent heartburn despite PPI therapy, but it does provide information on the efficacy of Famotidine in treating symptomatic GERD and erosive esophagitis. However, the most appropriate next step would be to conduct further diagnostic testing, such as 24-hour pH/impedance testing, to guide future management decisions 2.

From the Research

Next Steps in Management

The patient presents with persistent heartburn despite Proton Pump Inhibitor (PPI) therapy, which necessitates further investigation to determine the best course of action. Considering the patient's symptoms and the results of the upper endoscopy, the following options are available:

• 24-hour pH/impedance testing on PPI: This test can help assess the relationship between symptoms and reflux episodes while the patient is on PPI therapy 3, 4, 5.
• 48-hour wireless pH testing after stopping PPI for 7 days: This test can help determine if the patient has gastroesophageal reflux disease (GERD) and assess the severity of acid reflux 3, 4.
• Add famotidine 40 mg before bed: Adding an H2 receptor antagonist (H2RA) like famotidine may help alleviate symptoms, but its effectiveness in this scenario is unclear.
• Sucralfate 1,000 mg 4 times daily: Sucralfate is a medication that can help protect the esophagus from acid reflux, but its use in this scenario is not supported by the available evidence.

Rationale for Choosing the Best Next Step

The best next step in management would be to perform 24-hour pH/impedance testing on PPI or 48-hour wireless pH testing after stopping PPI for 7 days. These tests can help determine if the patient has GERD and assess the severity of acid reflux, which is essential in guiding further treatment decisions 3, 4, 5. The choice between these two tests depends on the clinical scenario and the availability of resources.

Key Considerations

• The patient's symptoms and medical history should be taken into account when choosing the best next step in management.
• The results of the upper endoscopy and any previous tests should be considered when interpreting the results of further testing.
• The patient's response to PPI therapy and any other treatments should be monitored and adjusted as necessary.
• Studies have shown that pH impedance monitoring off PPI can be useful in unproven GERD, and on-PPI pH impedance monitoring may not provide additional value in this scenario 4.
• The proton pump inhibitor test has been shown to be a sensitive but less specific test for diagnosing GERD, with an optimal duration of 1 week and a cutoff value of a decrease of heartburn score of more than 75% 6.