Lansoprazole compared with ranitidine for the treatment of nonerosive gastroesophageal reflux disease.
BACKGROUND
Traditionally, proton pump inhibitors are used primarily for patients with esophagitis. However, patients with nonerosive reflux disease may also benefit from these powerful medications.


OBJECTIVE
To compare the safety and symptom relief efficacy of lansoprazole with ranitidine therapy and with placebo.


METHODS
In 2 randomized, double-blind, multicenter trials of 901 patients with symptomatic reflux disease, which was confirmed by endoscopy to be nonerosive, received lansoprazole, 15 or 30 mg once daily; ranitidine, 150 mg twice daily; or placebo for 8 weeks.


RESULTS
Analysis of daily diary data during the first 4 weeks and for the entire 8 weeks of treatment revealed that patients who were treated with either dosage of lansoprazole reported significantly (P<.05) lower percentages of days and nights with heartburn, less pain severity of both day and night heartburn, fewer days of antacid use, and smaller amounts of antacid use compared with patients who were treated with ranitidine or placebo. The incidence of possible or probable treatment-related adverse reactions was comparable among the treatment groups; abdominal pain and diarrhea were the most commonly reported adverse events. No statistically significant differences were noted between treatment groups in laboratory analyses.


CONCLUSIONS
Lansoprazole therapy is more effective than standard dosages of ranitidine or placebo in relieving symptoms in patients with endoscopically confirmed non-erosive reflux esophagitis.
Richter
J E
JE
Cleveland Clinic, Ohio 44195, USA.
Campbell
D R
DR
Kahrilas
P J
PJ
Huang
B
B
Fludas
C
C
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000863:Antacids / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004945:Esophagoscopy; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D054328:Proton Pump Inhibitors; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000863:Antacids; D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D011899:Ranitidine; D009853:Omeprazole