Comparison of pantoprazole 20 mg to ranitidine 150 mg b.i.d. in the treatment of mild gastroesophageal reflux disease.
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.


CONCLUSIONS
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.
Kaspari
S
S
Biedermann
A
A
Mey
J
J
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000284:Administration, Oral; D000328:Adult; D001562:Benzimidazoles / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D011788:Quality of Life; D011899:Ranitidine / Q000008:administration & dosage*; D013454:Sulfoxides / Q000008:administration & dosage*; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D004791:Enzyme Inhibitors; D013454:Sulfoxides; D011899:Ranitidine; D000077402:Pantoprazole; D009853:Omeprazole