Standard and High-Dose PPIs Provide Comparable Efficacy for Sustained Resolution of Heartburn: Confirmation of GERD Treatment Guidelines for Lowest Effective Dose

Purpose: A diagnosis of GERD can be made based on typical symptoms of heartburn and regurgitation, and empiric use of a proton pump inhibitor (PPI) is recommended. While data support the use of higher than standard doses of a PPI for 8 weeks to achieve healing of erosive esophagitis, data do not support the use of these ‘double' doses for long-term control of symptoms beyond 8 weeks, or in non-erosive disease (NERD) despite current prescribing behavior. Methods: For example, a clinical study compared the 2-week and 4-week efficacy of esomeprazole (40 mg and 20 mg) and omeprazole (20 mg) in 1,282 patients with NERD1. Results: The percentage of patients (pts) with complete resolution of heartburn (HRT) for the 2- and 4-week treatment periods is listed in the table below. There was no significant difference between any of the treatment groups for resolution of HRT (p>0.05). In contrast, a clinical study comparing the efficacy of omeprazole 10 and 20 mg in a similar NERD population showed a clear dose-response: complete resolution of heartburn (last 7 days of a 4-week treatment) was significantly (p<0.002) higher in the omeprazole 20 mg group (48%) versus the omeprazole10 mg (27%) or placebo (5%) 2. Taken together, these data support that the apparent lack of a PPI dose-response in NERD is limited to doses >20 mg, and that a standard PPI dose is effective for complete resolution of heartburn in patients with uncomplicated heartburn. ACG guidelines for treatment of GERD recommend administering the lowest effective dose for patients who require long-term PPI therapy, yet the vast majority of prescriptions over the past 12 months (May, 2012 to April, 2013) were for a higher than standard dose (esomprazole 40 g - 94%; lansoprazole 30 mg - 94%; dexlansoprazole 60 mg - 93%; pantoprazole 40 mg - 96%; omeprazole 40 mg - 27%)3. Only rabeprazole 20 mg (100%) and omeprazole 20 mg (72%) were predominantly prescribed for a standard dose. Conclusion: In conclusion, these data support that a standard and double-dose of a PPI provide comparable efficacy for complete resolution of heartburn in patients who require long-term PPI therapy, and that a change in prescribing behavior will be needed for the cost effective treatment of patients with GERD.Table: PTS with COMPLETE RESOLUTION OF HRT (last 7days) 1