Intravenous pantoprazole as initial treatment in patients with gastroesophageal reflux disease and a history of erosive esophagitis: a randomized clinical trial.
We sought to evaluate safety and efficacy of IV pantoprazole when used as initial therapy in patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) in a double-blind, placebo-controlled, randomized, parallel-group study. Patients were randomized to 7 days of once-daily IV or oral pantoprazole (40 mg) or placebo. Efficacy variables included maximal acid output, basal acid output, and changes from baseline in frequency/severity of GERD symptoms, and frequency of antacid usage. Seventy-eight patients were randomized (n=26/27/25 [IV/oral/placebo]). Mean maximal acid output was 8.4, 6.3, and 20.9 mEq/h for IV or oral pantoprazole, and placebo, respectively. For pantoprazole versus placebo, maximal and basal acid output were significantly lower (P<.001) and there was a numerical trend toward improved GERD and antacid usage. Both treatments were well tolerated. In conclusion, IV/oral pantoprazole were similarly effective in suppressing basal and pentagastrin-stimulated gastric acid secretion in GERD patients with a history of EE.
Pratha
Vijaya
V
Clinical Applications Laboratories, 3330 Third Ave, Suite 330, San Diego, California 92103, USA.
Hogan
Daniel L
DL
Lynn
Richard B
RB
Field
Brian
B
Metz
David C
DC
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000284:Administration, Oral; D000328:Adult; D000536:Aluminum Hydroxide / Q000627:therapeutic use; D000704:Analysis of Variance; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D001837:Body Weights and Measures; D004311:Double-Blind Method; D004338:Drug Combinations; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005744:Gastric Acid / Q000502:physiology; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008276:Magnesium Hydroxide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077402:Pantoprazole; D015990:Placebo Effect; D012720:Severity of Illness Index; D012824:Silicic Acid / Q000627:therapeutic use; D013454:Sulfoxides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D004338:Drug Combinations; D013454:Sulfoxides; D012824:Silicic Acid; D000536:Aluminum Hydroxide; C036656:Gelusil; D000077402:Pantoprazole; D009853:Omeprazole; D008276:Magnesium Hydroxide