Short- and long-term therapy for reflux oesophagitis in the elderly: a multi-centre, placebo-controlled study with pantoprazole

Aliment Pharmacol Ther. 2003 Jun 1;17(11):1399-406. doi: 10.1046/j.1365-2036.2003.01593.x.

Abstract

Background: No placebo-controlled clinical trials have yet been published on the efficacy of therapy in older subjects with oesophagitis.

Aim: To evaluate the efficacy of pantoprazole in preventing the recurrence of oesophagitis in elderly subjects.

Methods: One hundred and sixty-four patients aged 65 years and over with acute oesophagitis were treated openly with pantoprazole, 40 mg daily, for 8 weeks. Patients with documented healing of erosive oesophagitis were then treated with pantoprazole, 20 mg daily, for 6 months. Thereafter, cured patients were randomized to receive pantoprazole, 20 mg daily, or placebo for the following 6 months. Clinical evaluations were performed every 2 months, and endoscopy was repeated after 8 weeks and after 6 and 12 months and/or whenever symptoms suggested a relapse of oesophagitis.

Results: After 8 weeks, the healing rates of oesophagitis were 81.1% (75.1-87.1%) and 93.7% (89.7-97.7%) by intention-to-treat and per protocol analyses, respectively. After 6 months, the corresponding values were 82% (75.4-88.5%) and 92.4% (87.6-97.2%), respectively. After 12 months, the per protocol and intention-to-treat healing rates of oesophagitis were 95.1% (88.5-100%) and 79.6% (68.3-90.9%), respectively, in the treatment group vs. 32.7% (19.9-45.4%) and 30.4% (18.3-42.4%), respectively, in the placebo group (P = 0.0001). Heartburn, acid regurgitation and chest pain were significantly associated with the relapse of oesophagitis (P = 0.0001), whereas hiatus hernia, Helicobacter pylori infection, concomitant diseases and treatments were not.

Conclusion: In the elderly, pantoprazole was highly effective in healing and reducing the relapse of oesophagitis; discontinuing active treatment after 6 months was associated with a significant increase in the relapse rate.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Aged
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / therapeutic use*
  • Benzimidazoles / adverse effects
  • Benzimidazoles / therapeutic use*
  • Double-Blind Method
  • Esophagitis, Peptic / drug therapy*
  • Follow-Up Studies
  • Humans
  • Omeprazole / analogs & derivatives
  • Pantoprazole
  • Prospective Studies
  • Recurrence
  • Sulfoxides / adverse effects
  • Sulfoxides / therapeutic use*
  • Treatment Outcome

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Benzimidazoles
  • Sulfoxides
  • Pantoprazole
  • Omeprazole