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

Abstract

Background: 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 min before the first daily meal, these agents are commonly used suboptimally, which adversely affects symptom relief. No study to date has 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 commonly recommended dosing regimen and to evaluate the economic impact of suboptimal PPI dosing in GERD patients. Methods: Patients with persistent heartburn symptoms ≥ 3 times per week treated with omeprazole 20 mg daily were enrolled and randomized to commonly recommended dosing or continued suboptimal dosing of omeprazole. The primary outcomes were changes in symptom, frequency, and severity, as determined using the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) 4 weeks after the intervention was administered. In secondary analysis, an alternative measure of symptom load was used to infer potential costs. Results: Sixty-four patients were enrolled. GSAS symptom, frequency, and severity scores were significantly better when dosing was optimized for overall and heartburn-specific symptoms (P < 0.01 for all parameters). 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 USA. Discussion: Low-cost efforts to promote commonly recommended PPI dosing can dramatically reduce GERD symptoms and related economic costs. ClinicalTrials.gov, number: NCT02623816.