Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis

Abstract

SUMMARY AimTo assess the relationship between the percentage of time intragastric pH >4.0 and healing of erosive oesophagitis. MethodsIn this proof-of-concept study, adults with endoscopically verified Los Angeles grade C or grade D erosive oesophagitis were randomly assigned to oral esomeprazole 10 or 40 mg once daily for 4 weeks. On day 5, patients underwent 24-h pH monitoring. At 4 weeks, erosive oesophagitis healing status was endoscopically assessed. Investigators scored gastro-oesophageal reflux disease symptoms on a 4-point scale [none to severe (0-3)] before and 4 weeks after treatment. The percentage of time intragastric pH was >4.0 and healing status were correlated and tested for significance using a Spearman rank correlation (r).Results 103 patients had evaluable data (mean age, 48.7 years; 65% men). Mean percentages of time with intragastric pH >4.0 on day 5 in patients with healed and unhealed erosive oesophagitis were 61% and 42%, respectively (P ¼ 0.0002), indicating that erosive oesophagitis healing rates were positively related to the percentage of time intragastric pH was >4.0. Greater intragastric acid control correlated with lower final daytime and night-time heartburn and acid regurgitation symptom scores (r ¼ )0.029, )0.029 and )0.021; P ¼ 0.003, 0.003 and 0.032, respectively). ConclusionA positive relationship between intragastric acid control and erosive oesophagitis healing was demonstrated.

Management of reflux esophagitis: does the choice of proton pump inhibitor matter?

“…Healing rates in patients with RE receiving acid-suppressive therapy are directly related to the duration of time that intragastric pH > 4 can be maintained during treatment (21)(22)(23)(24). At the standard oral dose of 40 mg, esomeprazole has been shown to provide more effective acid control (intragastric pH > 4) than standard doses of lansoprazole (25)(26)(27)(28) or pantoprazole (25)(26)(27)29).…”

A model of healing of Los Angeles grades C and D reflux oesophagitis: is there an optimal time of acid suppression for maximal healing?

“…Full details of study methods are published elsewhere. 9 Briefly, men and women (aged 18-75 years) had to have oesophagogastroduodenoscopy (EGD)-diagnosed RO (LA grade C or D) within 7 days prior to study entry. Patients were excluded if they had clinically relevant gastrointestinal bleeding, non-acid-related oesophagitis, history of gastric or oesophageal surgery, bleeding disorders, abnormal laboratory values or the presence of any condition likely to compromise safety and efficacy assessments.…”

“…9 As part of an exploratory analysis, we sought to characterize this relationship further, in terms of whether there is an apparent optimal time of acid suppression for maximal probability of healing.…”

The effect of time‐of‐day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a Dual Delayed Release proton pump inhibitor

“…Although no firm target has been established, studies have suggested that there exists a clinically relevant relationship between the duration of sustained 24-h intragastric pH > 4 and healing of erosive oesophagitis. [32][33][34] In addition, we did not assess changes in acid volume produced after treatment with dexlansoprazole MR at different times of day, an observation that may have offered a correlate of clinical interest. As the previous food effect study with dexlansoprazole MR 26 concluded that the drug could be administered without regard to meals or the timing of meals, a possible limitation of the current study may be that each dose was administered 30 min before a meal.…”