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Clinical Trial
, 17 (11), 1399-406

Short- And Long-Term Therapy for Reflux Oesophagitis in the Elderly: A Multi-Centre, Placebo-Controlled Study With Pantoprazole

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Clinical Trial

Short- And Long-Term Therapy for Reflux Oesophagitis in the Elderly: A Multi-Centre, Placebo-Controlled Study With Pantoprazole

A Pilotto et al. Aliment Pharmacol Ther.

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.

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