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Esomeprazole in acute and maintenance treatment of reflux oesophagitis: a multicentre prospective study

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Abstract

Introduction

The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission.

Methods

A total of 235 patients with endoscopically proven reflux oesophagitis were enrolled in this study, which consisted of two phases (healing and maintenance therapy). Patients who showed complete endoscopic and symptomatic healing at the end of 4 or 8 weeks were switched to maintenance treatment with esomeprazole 20 mg q.d. for 12 weeks. The primary efficacy endpoint was healing of reflux oesophagitis at week 8. Secondary assessments included the proportion of patients with symptomatic relapse in the maintenance phase.

Results

At the end of week 8, 88% (95% life-table confidence intervals [CI]: 84%, 92%) of patients were healed endoscopically and 90.6% of the patients were asymptomatic. Patient age, gender and Helicobacter pylori status had no effect on the efficacy of treatment. During the 12-week maintenance treatment phase, symptomatic relapse ratios were 0.5%, 2.2%, and 0%, for the first, second, and third 4-week periods, respectively. The proportions of patients satisfied with treatment were 95% and 99.4% at the end of acute and maintenance treatment, respectively. The most common adverse effects were headache, upper respiratory tract infection and abdominal pain.

Conclusions

Esomeprazole is effective in the healing of reflux oesophagitis, the resolution of heartburn, and in maintaining symptomatic remission. The effectiveness of esomeprazole in patients with gastroesophageal reflux disease is not affected by the presence of H. pylori.

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Authors and Affiliations

  1. School of Medicine, Department of Gastroenterology, Marmara University, Istanbul, Turkey

    Ozlen Atug, Adnan Giral & Cem Kalayci

  2. School of Medicine, Department of Gastroenterology, Uludag University, Bursa, Turkey

    Enver Dolar

  3. School of Medicine, Department of Gastroenterology, Akdeniz University, Antalya, Turkey

    Fahri Isitan

  4. Department of Gastroenterology, Ankara Specialist Training Education & Research Hospital, Ankara, Turkey

    Dilek Oguz

  5. Istanbul Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey

    Oya Ovunc

  6. School of Medicine, Department of Gastroenterology, Karadeniz Technical University, Trabzon, Turkey

    Orhan Ozgur

  7. School of Medicine, Department of Gastroenterology, Ankara University, Ankara, Turkey

    Irfan Soykan

  8. School of Medicine, Department of Gastroenterology, Dokuz Eylül University, Izmir, Turkey

    Ilkay Simsek

  9. School of Medicine, Department of Gastroenterology, Gazi University, Ankara, Turkey

    Selahattin Unal

  10. Department of Gastroenterology, Okmeydani SSK Hospital, Istanbul, Turkey

    Necati Yenice

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  1. Ozlen Atug
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Correspondence to Cem Kalayci.

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Atug, O., Giral, A., Kalayci, C. et al. Esomeprazole in acute and maintenance treatment of reflux oesophagitis: a multicentre prospective study. Adv Therapy 25, 552–566 (2008). https://doi.org/10.1007/s12325-008-0071-5

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  • DOI: https://doi.org/10.1007/s12325-008-0071-5

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