Patients on 20-mg maintenance doses of esomeprazole reported no more than mild symptom severity.
Current guidelines recommend only 2 options for patients who need long-term treatment for gastroesophageal reflux disease (GERD): acid suppression with a proton pump inhibitor (PPI) or anti-reflux surgery.
A new post hoc analysis of patients from the Long-Term Usage of Esomeprazole vs Surgery for Treatment of Chronic GERD (LOTUS) trial looked at the long-term effect of the esomeprazole 20-mg maintenance dose on symptoms and quality of life in participants with chronic, symptomatic GERD responsive to PPI treatment.
The results, published online on October 31, 2014, in Current Medical Research & Opinion, indicate that patients taking PPIs over 5 years report good quality of life and few adverse events.
The 2006 LOTUS study compared laparoscopic anti-reflux surgery with esomeprazole maintenance therapy and found that either option is effective for most patients. Follow-up at 5 years uncovered that most patients had sustained relief. The approach used in LOTUS’s PPI arm for patients whose symptoms were inadequately controlled with esomeprazole 20 mg once daily was to increase the dose to 40 mg once daily, then 20 mg twice daily. The 40 mg regimens were considered healing doses, and patients eventually returned to a 20-mg daily maintenance dose if possible.
Among 256 patients randomized to esomeprazole 20 mg once daily in LOTUS, approximately two-thirds (n = 157) remained on the maintenance dose until the end of follow-up or study discontinuation. Ninety-nine patients reported inadequate symptom control and required higher (healing) doses. Of those, 29 returned to the maintenance dose.
Certain patient characteristics were associated with the need for dose escalation: longer GERD duration, smoking, female sex, absence of Helicobacter pylori infection, and high supine baseline acid reflux into the esophagus.
Patients whose symptoms were controlled with esomeprazole 20 mg once daily reported good quality of life with no more than mild symptom severity. Serious adverse events were rare.
This is the first study to provide solid evidence supporting what the guidelines for GERD treatment already suggest: patients’ PPI doses can and should be down-titrated based on clinical symptom control.