Heartburn severity does not predict disease severity in patients with erosive esophagitis

Abstract

Background: For patients with gastroesophageal reflux disease (GERD), it is often assumed by treating physicians that the severity of heartburn correlates with the severity of erosive esophagitis (EE).

Objective: This is a post hoc analysis of data from 5 clinical trials that investigate the relationship between the baseline severity of heartburn and the baseline severity of EE.

Methods: Patients with endoscopically confirmed EE were assessed for heartburn symptoms with a 4-point scale at baseline and during treatment for 8 weeks with various proton pump inhibitors in 5 double-blind trials in which esomeprazole was the common comparator. EE was graded with the Los Angeles (LA) classification system. In these trials, healing and symptom response were evaluated by endoscopy and questionnaire after 4 weeks of treatment. Patients who were not healed were treated for an additional 4 weeks and reevaluated.

Results: A total of 11,945 patients with endoscopically confirmed EE participated in the 5 trials, with patients receiving esomeprazole 40 mg (n = 5068), esomeprazole 20 mg (n = 1243), omeprazole 20 mg (n = 3018), or lansoprazole 30 mg (n = 2616). Approximately one quarter of the 11,945 GERD patients in these 5 trials had severe EE (defined as LA grades C or D), regardless of their baseline heartburn severity.

Conclusion: The severity of GERD symptoms does not correlate well with disease severity. These findings indicate that endoscopy may have value in GERD patients in identifying those with EE, and if empirical therapy is chosen, then longer courses (4-8 weeks) of antisecretory therapy may be necessary to ensure healing of unrecognized esophagitis.

Figure 1

Severe erosive esophagitis (EE; Los Angeles grades C and D) was observed in a similar percentage of patients, regardless of the baseline severity of heartburn. The observed rates of 22% to 31% mean that 25% of patients had moderate-to-severe EE, regardless of their heartburn status (odds ratio, 1.2; 95% confidence interval, 0.8-1.7).

Figure 2

Percentage of patients with both healed erosive esophagitis and resolution of heartburn symptoms after 4 weeks of treatment.