2017-08-07 18:50:29 UTC

White Paper Provides Insight Into Drug Development for Gastroesophageal Reflux Disease (GERD)

Aug. 8, 2017

Future GERD drug trials must move away from traditional therapeutic endpoints and toward a more holistic approach that includes patient-reported outcomes.

The introduction of proton pump inhibitors (PPIs) more than 20 years ago revolutionized the management of gastroesophageal reflux disease (GERD). However, it is all too obvious to those physicians who care for these patients that PPIs do not address all symptoms in all patients who carry the diagnosis of GERD. The AGA Center for Diagnostics and Therapeutics has released a new white paper outlining next steps in improving treatment options for patients with GERD. The white paper, Optimal Strategies to Define and Diagnose Gastroesophageal Reflux Disease, is available in the August issue of Clinical Gastroenterology and Hepatology.

Key takeaways from the white paper:

1. Diagnosis of GERD may be complicated by overlap with other conditions, including functional dyspepsia, gastroparesis and eosinophilic esophagitis. Neither heartburn nor regurgitation is highly specific or sensitive for the diagnosis.

2. While PPIs heal erosive esophagitis (EE), not all GERD patients have EE and many patients remain dissatisfied with their response to PPI treatment. PPI partial responders now comprise a major proportion of patients seen by gastroenterologists in the clinical setting.

3. Clinical trials of combination therapy with a PPI and a motility modifying agent have produced disappointing result, perhaps partly due to enrollment of patients without the most appropriate symptom profile. Multiple patient-reported outcomes (PROs) instruments have now been developed.

4. Future intervention trials in GERD should target patients with objective criteria for GERD and incomplete response to PPI treatment. Endpoints must include objective assessment of PROs and quality of life.

Key message for your patients with GERD: the pharmaceutical industry is beginning to put patients first in new drug trials — therapies are being evaluated with consideration for patients’ perceptions of the efficacy of the treatment on their symptoms. We’re hopeful that this new focus will lead to the development of new treatment options. For resources to help you talk to your patients with GERD and educate them on their condition, visit www.gastro.org/GERD.

This white paper was developed based on expert discussion at the 2016 AGA Drug Development Conference, sponsored by the AGA Center for Diagnostics and Therapeutics. Learn more in this editorial by conference co-chairs Colin Howden, MD, AGAF, and Nimish Vakil, MD, AGAF, or view the related white papers on functional dyspepsia, eosinophilic esophagitis (EoE) and gastroparesis.

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