Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial)

Abstract

Introduction: Proton pump inhibitors (PPIs) are potent inhibitors of acid secretion and are the mainstay of therapy for gastroesophageal reflux disease (GERD). Initially designed to be taken 30 minutes before the first daily meal for optimal benefit, these agents are commonly used suboptimally, which adversely affects symptom relief. No study to date has, however, assessed whether correcting dosing regimens would improve symptom control. The objective of this study was to determine whether patients with persistent GERD symptoms on suboptimal omeprazole dosing experience symptomatic improvement when randomized to an optimal dosing regimen, and to evaluate the economic impact of suboptimal PPI dosing in GERD patients. Methods: Patients with heartburn symptoms ≥3 times per wk treated with omeprazole 20 mg were enrolled and observed for 2 wks on their current regimen. They were then randomized to optimal dosing (n=24) or continued suboptimal dosing (n=40) of omeprazole for 4 wks. Patients randomized to optimal dosing completed the study, while the remaining patients were further randomized to optimal (n=17) or continued suboptimal (n=23) dosing for an additional 4 wks. The primary endpoints were changes in symptom, frequency, and severity as determined using the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) at 6 and 10 wks. Baseline descriptive statistics were calculated and compared between study arms. The primary outcomes were changes in symptom, frequency, and severity, as determined using the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) 4 wks after the intervention was administered. In a secondary analysis, an alternative measure of symptom load was used to infer potential costs. Results: Sixty-four patients were enrolled with no differences in baseline demographic data (Table 1). GSAS symptom, frequency, and severity scores were significantly improved when dosing was optimized for overall and heartburn specific symptoms (P < 0.01 for all parameters) (Figure 1). Cost savings resulting from reduced medical care and workplace absenteeism were estimated to be $159.60 per treated patient, with cost savings potentially exceeding $4 billion annually in the U.S.Figure: Comparison of mean GSAS (a) symptom scores, (b) frequency scores, and (c) severity scores.Table: Baseline data.Conclusion: Patients administered a brief intervention to promote optimal PPI dosing demonstrated significant overall symptom improvement. Proper education and PPI dosing should serve to reduce the burden of persistent GERD symptoms and related healthcare costs of uncontrolled disease.