Purpose: To compare rates of GERD symptom resolution in patients with and without EE at baseline after 4 weeks of treatment with oral esomeprazole 40 mg daily.
Methods: Adults aged 18–70 y with a history of frequent heartburn (≥2 d/wk for the past week and on average for the past 3 months) were eligible for this multicenter, open-label study (D9612L00083). Baseline endoscopy established presence and severity of EE (Los Angeles [LA] grades A–D; patient-blinded). After stratification by presence or absence of EE, all patients received oral esomeprazole 40 mg daily for 4 weeks. When a stratum reached its predetermined quota of ∼175 patients, additional patients received no treatment, but endoscopy results were retained for prevalence estimates. GERD symptoms were reassessed at 2 and 4 weeks by questionnaire; symptom resolution was defined as patients recording ‘none’ on a scale of ‘none’, ‘mild’, ‘moderate’ or ‘severe’. χ2 Tests were performed to compare symptom resolution rates in patients with and without EE.
Results: Of 399 patients who underwent endoscopy, 205 had EE, for an EE prevalence of 51.4%. Of those with EE, 29%, 38%, 26%, and 7% had LA grades A, B, C, and D, respectively. The intention-to-treat population was composed of 356 patients (men, 42%; white, 81%; mean age, 44 y; mean BMI, 30.1 kg/m2). After 2 and 4 weeks of esomeprazole treatment, heartburn resolution rates were higher in patients with EE (N = 179) than without EE (N = 177) at baseline (table). At baseline, all patients had heartburn and most had acid regurgitation (87%) and epigastric pain (79%). Only 47% had dysphagia at baseline, which likely decreased the power to detect between-group differences in dysphagia resolution rates.
Conclusions: GERD symptom resolution rates were higher in patients with EE than those without EE after 4 weeks of daily esomeprazole 40-mg treatment. Given this observation, GERD symptom resolution should not be accepted as an indicator of benign esophageal mucosal pathology. Supported by AstraZeneca LP