For millions suffering from chronic acid reflux, finding lasting relief can be difficult. A new clinical trial will investigate whether genotype-guided treatment can improve results.
The study, led by UF Health Jacksonville and the University of Florida College of Pharmacy, will be the first to examine whether genotype-guided dosing of proton pump inhibitor medications, or PPIs, can improve treatment outcomes for erosive esophagitis. Researchers plan to enroll 200 patients over the next year.
Erosive esophagitis occurs when chronic acid reflux irritates and wears away the inner lining of the esophagus. Symptoms include persistent heartburn, painful or difficult swallowing and regurgitation. The condition is diagnosed through an upper endoscopy and typically requires eight to 12 weeks of medication to heal.
PPIs are commonly prescribed to block stomach acid production and allow the esophagus to recover. However, researchers say genetic differences can affect how quickly patients metabolize the medications, potentially altering their effectiveness.
“Pharmacogenetic testing can identify patients who metabolize PPIs too quickly and require a higher dose for relief, as well as patients who metabolize the drug slowly and may obtain relief with lower doses,” said Ruchir Puri, M.D., M.S., an associate professor of surgery and a board-certified gastrointestinal surgeon at UF Health Jacksonville. “Long-term use of PPIs can increase a patient’s risk of infections, bone fractures and possible kidney disease.”
The study will evaluate differences in healing rates between patients whose PPI doses are guided by genetic testing and those treated with standard dosing. Investigators hope the findings will provide strong evidence for pharmacogenetic testing in patients with erosive esophagitis.
“We want to see if genotype-guided dosing improves the healing rates of erosive esophagitis,” said Larisa Cavallari, Pharm.D., chair and a professor of pharmacotherapy and translational research in the UF College of Pharmacy and co-director of the UF Center for Pharmacogenomics and Precision Medicine. “If it does, then this could become the standard of care for treating patients with erosive esophagitis at UF Health.”
Gastroesophageal reflux disease, or GERD, is one of the most common gastrointestinal disorders worldwide. Researchers estimate erosive esophagitis affects 6% to 15% of patients with GERD and up to 30% of patients who undergo an upper endoscopy.
“GERD is an extremely common disorder, and the fact that one simple test could potentially help us better treat millions of people who suffer from this disease is the most exciting aspect of our research,” Puri said.
According to Cavallari, current pharmacogenetic guidelines recommend increasing PPI doses by 50% to 100% for patients with erosive esophagitis who metabolize the medications more rapidly than usual. Even patients considered normal metabolizers may benefit from higher PPI doses. However, no clinical trials have evaluated whether these recommendations improve patient outcomes.
The study — funded by UF’s University Research Initiative — also reflects broader efforts across UF Health to expand pharmacogenetic testing and precision medicine initiatives in Jacksonville. “At UF Health, we are doing the research and moving it into patient care, and it’s offering a novel way to optimize drug therapy,” said Cavallari, the Debbie DeSantis Excellence Professor in the college. “GERD can be really debilitating, but if genotype-guided treatment proves effective, then the opportunity exists to really improve the quality of life for patients treated at UF Health and beyond.”