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Short‐ and long‐term therapy for reflux oesophagitis in the elderly: a multi‐centre, placebo‐controlled study with pantoprazole
Author(s) -
Pilotto A.,
Leandro G.,
Franceschi M.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01593.x
Subject(s) - medicine , pantoprazole , heartburn , gastroenterology , placebo , concomitant , esophagitis , randomized controlled trial , reflux , omeprazole , surgery , alternative medicine , disease , pathology
Summary 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.