Onset of relief of symptoms of gastroesophageal reflux disease: post hoc analysis of two previously published studies comparing pantoprazole 20 mg once daily with nizatidine or ranitidine 150 mg twice daily.

Background: Systematic assessments of the onset of symptom relief in the treatment of gastroesophageal reflux disease (GERD) are lacking.

Objective: This work evaluated the time interval until complete symptom relief from heartburn (including both daytime and nighttime heartburn) and acid regurgitation in patients with GERD or endoscopy-negative GERD (NERD) during the first 7 days of treatment with pantoprazole, nizatidine, or ranitidine.

Methods: This was a post hoc reanalysis of data from 2 previously published, multicenter, randomized, double-blind, active-controlled, parallel-group studies. Male and female patients aged >or=18 years with endoscopically proven GERD or NERD (Hetzel-Dent grade >or= [trial 1] or Savary-Miller grade 0 or 1 [trial 2]) were enrolled. Patients were required to have had reflux symptoms for the previous >or=3 months, with >or=1 symptom (ie, daytime heartburn, nighttime heartburn, or acid regurgitation) for >or=4 of the past 7 days in trial 1 or >or=1 symptom (ie, heartburn, acid eructation, or painful swallowing) of at least moderate intensity for the past 3 days in trial 2. The treatments were pantoprazole 20 mg once daily in both trials, nizatidine 150 mg BID in trial 1, or ranitidine 150 mg BID in trial 2. Presence and severity of symptoms were recorded on daily diary cards using a 4-point Likert-type scale.

Results: In total, 114 patients from trial 1 and 307 patients from trial 2 were evaluable for heartburn, and 58 patients from trial l and 271 patients from trial 2 were evaluable for acid regurgitation. In both studies, there were no significant differences in baseline characteristics between pantoprazole recipients and nizatidine or ranitidine recipients, with the exception of more men than women in trial 1 compared with trial 2 (P < 0.001). On day 2 of trial 1, 23 (39.0%) and 8 (14.5%) of pantoprazole and nizatidine recipients, respectively, experienced complete relief from heartburn (P < 0.01). The differences between groups remained statistically significant through day 7, when 28 (47.5%) and 8 (14.5 %) of pantoprazole and nizatidine recipients had no heartburn (P < 0.001). There were no differences in control of acid regurgitation over 7 days with pantoprazole compared with nizatidine or ranitidine, except at days 2 and 4 of trial 1, when significantly more patients receiving pantoprazole experienced relief from acid regurgitation than those receiving nizatidine (day 2: 60.6% [n = 20] vs 20.0% [n = 5], P < 0.01; day 4: 48.5% [n =16] vs 24.0% [n = 6], P < 0.05).

Conclusion: In this post hoc reanalysis of data from 2 previously published clinical trials, use of pantoprazole 20 mg once daily was associated with effective early relief from heartburn and acid regurgitation among these patients with GERD and NERD; relief occurred as fast as and, in some cases, even faster than that seen with nizatidine or ranitidine.