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First-week Clinical Responses to Dexlansoprazole 60 Mg and Esomeprazole 40 Mg for the Treatment of Grades A and B Gastroesophageal Reflux Disease

Abstract

Aim: To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.

Methods: We enrolled 175 adult patients with gastroesophageal reflux disease (GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole ( = 88) and esomeprazole ( = 87) for an intention-to-treat analysis. The primary end-points were the complete symptom resolution (CSR) rates at days 1, 3, and 7 after drug administration.

Results: Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3 (38.3% 18.4%, = 0.046). An increasing trend toward a higher CSR was observed in the dexlansoprazole group at day 7 (55.3% 36.8%, = 0.09). In the esomeprazole group, female sex was a negative predictive factor for CSR on post-administration day 1 [OR = -1.249 ± 0.543; 95%CI: 0.287 (0.099-0.832), = 0.022] and day 3 [OR = -1.254 ± 0.519; 95%CI: 0.285 (0.103-0.789), = 0.016]. Patients with spicy food eating habits achieved lower CSRs on day 1 [37.3% 21.4%, OR = -0.969 ± 0.438; 95%CI: 0.380 (0.161-0.896), = 0.027].

Conclusion: The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.

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