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Comparative effects of an omeprazole antacid complex-immediate release (OAC-IR) and omeprazole-delayed release (OME-DR) on omeprazole pharmacokinetics (PK) and gastric pH in healthy subjects

2003; Elsevier BV; Volume: 124; Issue: 4 Linguagem: Inglês

10.1016/s0016-5085(03)81144-7

1528-0012

Bonnie Hepburn, Barry Goldlust,

Eosinophilic Esophagitis

Aim: To compare the efficacy of 2 weeks versus 4 weeks of RAB treatment for the relief of GERD in patients with mild-to-moderate esophagitis.Methods: Patients aged 18 years and older with GERD symptoms and mild-to-moderate esophagitis who had received -< 1 antisecretory or prokinetic treatment course during the past 6 months were randomized to 2 groups: group 1 received RAB 20 mg qd for 14 days, followed by placebo qd for 14 days; group 2 received RAB 20 qd for 28 days.Symptoms were rated on the DeMeester and Johnson scale (0 to 10), evaluating the intensity, frequency, occurrence, and duration of symptoms.Enrolled patients had a score :>6 for their predominant symptom.Therapeutic success was defined as a score -<4.Heartburn and acid regurgitation were evaluated on days 0, 7, 14, and 28.The primary endpoint was the change in symptom score between day 0 and the last visit on treatment (day 14, group l ; day 28, group 2).Statistical equivalence was defined as the upper bound of the 95% confidence interval (CI) for the difference between the 2 groups < 1. Results: Of the intern-to-treat population (N = 260; 55% men; mean age, 48 yr), 73% were diagnosed with grade I esophagins (Savary-Moniner) and 27% with grade 2. No significant difference in change of symptom score was seen between groups 1 and 2 at treatment endpoint (6.93 vs 6.49, respectively; upper bound of CI=0.063) (table).Furthermore, there was no difference between the 2 groups in therapeutic success: 91.2% at day 14 (group 1) and 89.3% at day 28 (group 2) (p = 0.62).Only 9 patients discontinued the study due to adverse events (5, group 1; 4, group 2) Conclusions: Two weeks of RAB 20-rag treatment is as effective as 4 weeks' RAB 20-rag treatment for GERD symptom relief in patients with mild-to-moderate esophagitis, thereby demonstrating a significantly faster onset of symptom resolution compared with the standard treatment length.