1152 Distinguishing the Impact of Dexlansoprazole on Heartburn Versus Regurgitation in Patients With NERD or EE

Abstract

Purpose: To determine the impact of dexlansoprazole MR (DEX) on heartburn (HB) and regurgitation severity in nonerosive gastroesphophageal reflux disease (NERD) and erosive esophagitis (EE) patients. Methods: This was a post hoc analysis of patients enrolled in phase 3 studies either assessing the efficacy and safety of DEX vs placebo (PLB) for 24-hour HB relief in NERD or DEX vs lansoprazole (LAN) in EE healing. DEX 30 mg, DEX 60 mg, and PLB were administered to 315, 315, and 317 endoscopically confirmed NERD patients, respectively, in a randomized, double-blind, 4-week study. NERD patients were to have a ≥6 month history of HB. In two 8-week, double-blind, randomized healing studies, 2737 endoscopically confirmed EE patients received DEX 60 mg or LAN 30 mg. In all studies, the Patient Assessment of Upper Gastrointestinal-Symptom Severity questionnaire (PAGISYM) was administered at baseline to assess symptom severity. The PAGI-SYM was also completed at Weeks 2 and 4 of the NERD study, and at Weeks 4 and 8 during the EE healing trials. The PAGI-SYM, a validated questionnaire, includes items assessing severity of HB and regurgitation on a scale of 0 to 5 (no symptoms, mild, moderate, severe and very severe symptoms) yielding a HB/regurgitation subscale. Using the PAGI-SYM questions included in this subscale, we defined separate subscales for HB and regurgitation. Among patients who had both symptoms at baseline (defined as at least mild HB and at least mild regurgitation in the individual subscales), we looked at the change from baseline (CFB) in individual HB and regurgitation subscales along with the original combined HB/regurgitation subscale. Negative CFBs indicate symptom improvement. A CFB of ≥0.55 was considered the minimally important difference for the HB/regurgitation subscale score. Results: In the NERD study, 661 patients had both HB and regurgitation at baseline, as did 1909 patients in the EE study. Table 1 and Table 2 provide the mean CFB in the subscale scores for the NERD and EE patients, respectively. NERD patients receiving DEX 30 and 60 mg experienced significantly greater improvements in symptom severity for both HB and regurgitation compared to PLB. EE patients receiving DEX 60 mg had significantly greater improvements in HB/regurgitation and HB-only subscales at Week 4 compared to those receiving LAN. Conclusions: DEX appears to be effective in improving both the mechanical (regurgitation) and chemical (HB) aspects of GERD symptoms and this improvement is maintained for the duration of treatment. Table 1. NERD