What is the recommended management for a 69-year-old female with gastroesophageal reflux disease (GERD) controlled with Dexilant (dexlansoprazole) once daily, a small type I paraesophageal hernia, a history of pulmonary disease flare-up associated with COVID-19, mild fibrosis, osteoporosis, and improved GERD quality of life (QOL) symptom score?

From the Guidelines

The recommendation to continue medical therapy with Dexilant once daily for GERD management in this 69-year-old female patient with a small type I paraesophageal hernia is appropriate and guideline-concordant. The patient's GERD symptoms are well-controlled on current therapy, as evidenced by the significant improvement in her GERD-QOL score from 12 to 3 (on a scale where 50 represents severe symptoms) 1. Given her comorbidities, including mild pulmonary fibrosis, osteoporosis requiring injectable therapy, and previous COVID-related pulmonary issues, the conservative approach of maintaining medical management is reasonable. Some key points to consider in this decision include:

• The use of upper endoscopy in chronic GERD is generally not recommended for patients without alarm symptoms, such as dysphagia, bleeding, or weight loss 1.
• The patient's current symptom control and lack of alarm symptoms support the continuation of medical therapy.
• The decision to defer surgical intervention (fundoplication) unless she experiences another symptomatic flare-up appropriately weighs the risks of surgery (dysphagia, other GI complications) against the benefits, especially since her symptoms are currently well-controlled 1. This approach follows the principle of using the least invasive effective treatment and reserving surgery for cases where medical management fails or complications develop. Regular follow-up would be advisable to monitor symptom control and reassess if her condition changes.

From the FDA Drug Label

The provided drug labels do not directly address the question of whether continuing medical therapy with Dexilant for a 69-year-old female patient with GERD and a small type I paraesophageal hernia is guideline-concordant.

The patient's GERD is currently controlled with Dexilant once per day, and the GERD QOL returns a symptom score of 3, which is improved from 12 prior to PPI therapy.

• The decision to continue medical therapy seems reasonable given the patient's stable condition and the potential risks associated with surgical interventions like fundoplication, such as dysphagia and other lower GI concerns.
• However, without direct information from the drug labels regarding the management of GERD in patients with type I paraesophageal hernia, it's challenging to determine if this approach is strictly guideline-concordant.
• The provided drug labels primarily discuss the efficacy and safety of dexlansoprazole in treating erosive esophagitis and symptomatic non-erosive GERD, but do not specifically address the scenario of a patient with a small type I paraesophageal hernia 2 2.
• Given the lack of direct evidence, a conservative clinical decision would be to continue monitoring the patient's condition and adjust the treatment plan as necessary, considering the potential benefits and risks of ongoing medical therapy versus surgical intervention.

From the Research

Summary of Recommendation

The patient has gastroesophageal reflux disease (GERD) with a small type I paraesophageal hernia, and their symptoms are controlled with Dexilant once per day. The patient also has a history of pulmonary disease flareup and osteoporosis. The recommendation is to continue medical therapy for now, as all medications have reversible issues. If the patient has another flareup, a fundoplication may be considered, but the risk/benefit ratio is not favorable due to potential complications such as dysphagia and other lower GI concerns.

Guideline Concordance

The recommendation is guideline-concordant with the study by 3, which states that medication with a proton pump inhibitor (PPI) is the most common treatment for GERD, and that surgery with laparoscopic fundoplication is an invasive treatment alternative in select patients after thorough and objective assessments. The study by 4 also supports the use of Dexilant (dexlansoprazole) for the treatment of heartburn associated with nonerosive GERD and healing and maintenance of healing of all grades of erosive esophagitis.

Considerations

• The patient's GERD symptoms are well-controlled with Dexilant, with a symptom score of 3, which is improved from 12 prior to PPI therapy 3.
• The patient has a history of pulmonary disease flareup, but has been stable since then, and has some osteoporosis, for which they have just started injectable therapy 5.
• The risk of osteoporosis is increased with PPI use, but the overall incidence of hip fracture is not different between GERD patients with PPI use and the control cohorts 5.
• Dexlansoprazole has a unique dual delayed-release formulation, which releases drug at 2 points in time, and has been shown to be effective in the healing and maintenance of erosive esophagitis, and symptomatic non-erosive GERD 4, 6, 7.

Key Points

• Continue medical therapy with Dexilant for now, as all medications have reversible issues.
• Consider fundoplication if the patient has another flareup, but weigh the risk/benefit ratio due to potential complications.
• Monitor the patient's osteoporosis and adjust treatment as needed.
• Consider the unique formulation and efficacy of Dexilant in the treatment of GERD.