Comparison of Pantoprazole 20 mg to Ranitidine 150 mg b.i.d. in the Treatment of Mild Gastroesophageal Reflux Disease

Abstract

Background: Despite a high prevalence of mild gastroesophageal reflux disease (GERD), few studies investigated efficacy and safety of proton pump inhibitors in this indication. This randomized double-blind study compares pantoprazole to ranitidine in GERD 0 and I, i.e. reflux without esophagitis or with confined lesions only. Methods: Patients received either pantoprazole 20 mg o.a.d. or ranitidine 150 mg b.i.d. Outcome was assessed after 2 and 4 weeks. Primary criterion was relief of leading symptoms, i.e. heartburn, acid eructation and pain on swallowing, after 4 weeks of treatment. Results: According to the per-protocol (PP) analysis, 69% (100/144) and 80% (115/144) of patients in the pantoprazole group were relieved of leading symptoms after 2 and 4 weeks, respectively. The rates in the ranitidine group were 47% (62/133) and 65% (86/133). Thus, superiority of pantoprazole could be proven. Quality-of-life parameters improved more in the pantoprazole group and patients’ assessment of treatment was more favorable. Analysis for Helicobacter pylori status showed infection to lead to higher symptom relief rates. Both study medications were well tolerated. Conclusion: Pantoprazole 20 mg demonstrated superior efficacy with faster relief of reflux symptoms and similar tolerability compared to ranitidine 150 mg in the treatment of mild GERD.

Efficacy and Safety of Pantoprazole versus Ranitidine in the Treatment of Patients with Symptomatic Gastroesophageal Reflux Disease

“…The relief rates from key GERD symptoms noted in this current study were slightly lower than those reported in other studies comparing pantoprazole 20 mg once daily with ranitidine 300 mg once daily [11, 22]or 150 mg twice a day [23]. For example, in one study evaluating relief from heartburn, acid eructation, and pain on swallowing [22], on day 14 some 69% of the ITT patients receiving 20 mg pantoprazole (once daily in the morning) had achieved relief versus 48% of the patients receiving 300 mg ranitidine (once daily in the evening), with relief rates rising to 80 and 65% for pantoprazole and ranitidine, respectively, on day 28.…”

“…For example, in one study evaluating relief from heartburn, acid eructation, and pain on swallowing [22], on day 14 some 69% of the ITT patients receiving 20 mg pantoprazole (once daily in the morning) had achieved relief versus 48% of the patients receiving 300 mg ranitidine (once daily in the evening), with relief rates rising to 80 and 65% for pantoprazole and ranitidine, respectively, on day 28. Another study [23]reported similar relief rates of 69 and 80% on days 14 and 28, respectively, for 20 mg pantoprazole.…”

“…By improving GERD symptoms and providing pain relief, treatment with PPIs has been shown to improve patients’ mental health, social functioning, and quality of life [23, 27]. …”

“…The dose of 20 mg pantoprazole employed in this study has been shown to be superior to ranitidine in symptomatic patients with mild GERD [11, 22, 23], but this is the first time that a GERD cohort with potentially wide-ranging disease severity according to esophageal lesions has been studied for efficacy of 20 mg pantoprazole across a wide and comprehensive spectrum of GI symptoms.…”

What is the long term acid inhibitor treatment in gastroesophageal reflux disease? What are the potential problems related to long term acid inhibitor treatment in gastroesophageal reflux disease? How should these cases be followed?

“…In the meta-analysis of 6 randomized trials in which H2RA and placebo were compared, the incidence of all of the adverse effects was similar among the arms (RR: 1.13, 95% CI: 0.97-1.31) (39)(40)(41)(42)(43)(44). In the meta-analysis of 8 randomized trials that compared PPI and H2RA, no difference was found between the two groups of drugs in terms of all of the adverse effects (RR: 0.94, 95% CI: 0.86-1.02) and serious adverse effects (RR: 0.93, 95% CI: 0.85-1.01) (39,(45)(46)(47)(48)(49)(50)(51).…”