<p>Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial</p>

Abstract

Purpose: Research comparing the clinical efficacy of dexlansoprazole and esomeprazole has been limited. This study aims to compare the clinical efficacy of single doses of dexlansoprazole (modified-release 60 mg) and esomeprazole (40 mg) after 24-week follow-up in patients with mild erosive esophagitis. Methods: We enrolled 86 adult GERD subjects, randomized in a 1:1 ratio to two sequence groups defining the order in which they received single doses of dexlansoprazole (n=43) and esomeprazole (n=43) for 8 weeks as initial treatment. Patients displaying complete symptom resolution (CSR) by the end of initial treatment (8 weeks) were switched to on-demand therapy until the end of 24 weeks. Follow-up endoscopy was performed either at the end of 24 weeks or when severe reflux symptoms occurred. Five patients were lost to follow-up, leaving 81 patients (dexlansoprazole, n=41; esomeprazole, n=40) in the per-protocol analysis. Results: The GERDQ scores at 4-, 8-, 12-, 16-, 20-, and 24-week posttreatment were less than the baseline score. The CSR, rate of symptom relapse, days to symptom resolution, sustained healing rate of erosive esophagitis, treatment failure rate, and the number of tablets taken in 24 weeks were similar in both groups. The esomeprazole group had more days with reflux symptoms than the dexlansoprazole group (37.3±37.8 vs 53.9±54.2; P =0.008). In the dexlansoprazole group, patients exhibited persistent improvement in the GERDQ score during the on-demand period (week 8 vs week 24; P <0.001) but not in the esomeprazole group (week 8 vs week 24; P =0.846). Conclusions: This study suggests that the symptom relief effect for GERD after 24 weeks was similar for dexlansoprazole and esomeprazole. Dexlansoprazole exhibited fewer days with reflux symptoms in the 24-week study period, with better persistent improvement in the GERDQ score in the on-demand period. (ClinicalTrials. gov number: NCT03128736)

<p>A comparison between dexlansoprazole modified release–based and lansoprazole-based nonbismuth quadruple (concomitant) therapy for first-line <em>Helicobacter pylori</em> eradication: a prospective randomized trial</p>

“…This was proven in a comparative trial, where dexlansoprazole taken once daily showed better control of esophageal pH than 30 mg of lansoprazole taken once daily. Another, single-day pH study comparing the pharmacokinetic effects of different PPIs at 12–24 hrs postdose in healthy adult subjects reported that the mean percentage of time with a pH of more than 4 and the average of the mean pH were higher for dexlansoprazole than esomeprazole (60% vs 42%, p <0.001 and 4.5 vs 3.5, p <0.001, respectively) 30,31. In theory, it should be able to maintain a steady optimal intragastric pH for H. pylori eradication.…”

Pharmacokinetics of Esomeprazole Magnesium After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects

“…9,18,19 Even though meal consumption decreases AUC and C max in pharmacokinetics, acid suppression is not significantly impacted, as measured by the percentage of time for which the stomach pH remained more than 4 (pH > 4). 17,20 Food interactions with esomeprazole pharmacodynamics were not well examined in these trials and should be evaluated in future investigations integrating clinical, physiological, and PK parameters. We only propose that esomeprazole be administered in the fasting condition according to the instructions.…”

“…The pharmacokinetics of esomeprazole magnesium were significantly influenced by the consumption of high‐fat meals, as shown by a mean drop in AUC and a delay in T max . Because of the positive correlation between the plasma AUC and the antisecretory effects of PPIs, inhibition of intragastric acid secretion by esomeprazole increases with higher exposure (AUC), 16,17 therefore it might be expected that administration of esomeprazole with food intake would decrease its PD effects. However, the food intake buffers gastric acid, which increases the therapeutic effect of esomeprazole 9 .…”

Correlation between Psychosomatic Assessment, Heart Rate Variability, and Refractory GERD: A Prospective Study in Patients with Acid Reflux Esophagitis

“…The PPI was titrated to twice-daily PPI in the 2nd month for the patients who exhibited incomplete or partial response to the standard PPI regimen (once daily) [ 15 , 16 , 17 , 18 ]. At the end of initial treatment (8 weeks), all patients were switched to an on-demand therapy, using 60 mg dexlansoprazole successively for 3 days if the GERD symptom relapsed [ 19 ]. “Refractory GERD” is classified as exhibiting less than a 50% improvement in symptom relief and life quality (as measured by the GERDQLQ), or achieving a score equal to or greater than 20, in response to treatment with PPIs [ 15 , 20 ].…”