Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole

F. Pace, V. Annese, A. Prada, A. Zambelli, S. Casalini, P. Nardini, G. Bianchi Porro, Z. Rossi, P. Fenderico, F. Molinari, A. Molinari, M. Poletti, A. Benedetti, L. Bolognini, P. Cercamondi, S. Piergallini, N. Pieroni, F. Ridolfi, A. Palazzi, A. Agnolucci & 31 others P. Ceccatelli, F. Laurenzi, M. Grassini, G. Iaquinto, V. D'Onofrio, N. Giardullo, L. Pasquale, A. Sedici, R. Moschetta, G. Maurogiovanni, Biedo Costan, B. Germana, P. Lecis, F. Negrini, S. Signorelli, P. Landi, P. Malaguti, E. Roda, Vergori De, L. Gandolfi, F. Torresan, F. Chilovi, S. Benvenuti, T. Grasso, S. Adamo, A. Sabatino, A. Anderloni, P. M. Mannucci, P. A. Testoni, A. Andriulli, The Italian Rabeprazole Study Group

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background.: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. Aim.: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. Methods.: Patients (n = 560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2 × 10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. Results.: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p <0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8 ± 0.2 versus 4.7 ± 0.5 days of therapy to reach the first day with satisfactory heartburn relief, p = 0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. Conclusion.: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.

Original languageEnglish
Pages (from-to)741-750
Number of pages10
JournalDigestive and Liver Disease
Volume37
Issue number10
DOIs
Publication statusPublished - Oct 1 2005

Fingerprint

Rabeprazole
Esophageal Diseases
Peptic Esophagitis
Omeprazole
Gastroesophageal Reflux
Double-Blind Method
Maintenance
Heartburn
Therapeutics
Recurrence

Keywords

  • Curative/maintenance therapy
  • Gastro-oesophageal reflux disease
  • Heartburn
  • Rabeprazole

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole. / Pace, F.; Annese, V.; Prada, A.; Zambelli, A.; Casalini, S.; Nardini, P.; Bianchi Porro, G.; Rossi, Z.; Fenderico, P.; Molinari, F.; Molinari, A.; Poletti, M.; Benedetti, A.; Bolognini, L.; Cercamondi, P.; Piergallini, S.; Pieroni, N.; Ridolfi, F.; Palazzi, A.; Agnolucci, A.; Ceccatelli, P.; Laurenzi, F.; Grassini, M.; Iaquinto, G.; D'Onofrio, V.; Giardullo, N.; Pasquale, L.; Sedici, A.; Moschetta, R.; Maurogiovanni, G.; Costan, Biedo; Germana, B.; Lecis, P.; Negrini, F.; Signorelli, S.; Landi, P.; Malaguti, P.; Roda, E.; De, Vergori; Gandolfi, L.; Torresan, F.; Chilovi, F.; Benvenuti, S.; Grasso, T.; Adamo, S.; Sabatino, A.; Anderloni, A.; Mannucci, P. M.; Testoni, P. A.; Andriulli, A.; The Italian Rabeprazole Study Group.

In: Digestive and Liver Disease, Vol. 37, No. 10, 01.10.2005, p. 741-750.

Research output: Contribution to journalArticle

Pace, F, Annese, V, Prada, A, Zambelli, A, Casalini, S, Nardini, P, Bianchi Porro, G, Rossi, Z, Fenderico, P, Molinari, F, Molinari, A, Poletti, M, Benedetti, A, Bolognini, L, Cercamondi, P, Piergallini, S, Pieroni, N, Ridolfi, F, Palazzi, A, Agnolucci, A, Ceccatelli, P, Laurenzi, F, Grassini, M, Iaquinto, G, D'Onofrio, V, Giardullo, N, Pasquale, L, Sedici, A, Moschetta, R, Maurogiovanni, G, Costan, B, Germana, B, Lecis, P, Negrini, F, Signorelli, S, Landi, P, Malaguti, P, Roda, E, De, V, Gandolfi, L, Torresan, F, Chilovi, F, Benvenuti, S, Grasso, T, Adamo, S, Sabatino, A, Anderloni, A, Mannucci, PM, Testoni, PA, Andriulli, A & The Italian Rabeprazole Study Group 2005, 'Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole', Digestive and Liver Disease, vol. 37, no. 10, pp. 741-750. https://doi.org/10.1016/j.dld.2005.04.026
Pace, F. ; Annese, V. ; Prada, A. ; Zambelli, A. ; Casalini, S. ; Nardini, P. ; Bianchi Porro, G. ; Rossi, Z. ; Fenderico, P. ; Molinari, F. ; Molinari, A. ; Poletti, M. ; Benedetti, A. ; Bolognini, L. ; Cercamondi, P. ; Piergallini, S. ; Pieroni, N. ; Ridolfi, F. ; Palazzi, A. ; Agnolucci, A. ; Ceccatelli, P. ; Laurenzi, F. ; Grassini, M. ; Iaquinto, G. ; D'Onofrio, V. ; Giardullo, N. ; Pasquale, L. ; Sedici, A. ; Moschetta, R. ; Maurogiovanni, G. ; Costan, Biedo ; Germana, B. ; Lecis, P. ; Negrini, F. ; Signorelli, S. ; Landi, P. ; Malaguti, P. ; Roda, E. ; De, Vergori ; Gandolfi, L. ; Torresan, F. ; Chilovi, F. ; Benvenuti, S. ; Grasso, T. ; Adamo, S. ; Sabatino, A. ; Anderloni, A. ; Mannucci, P. M. ; Testoni, P. A. ; Andriulli, A. ; The Italian Rabeprazole Study Group. / Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole. In: Digestive and Liver Disease. 2005 ; Vol. 37, No. 10. pp. 741-750.
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title = "Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole",
abstract = "Background.: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. Aim.: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. Methods.: Patients (n = 560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2 × 10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. Results.: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9{\%}) patients in the rabeprazole group and in 231/237 (97.5{\%}) in the omeprazole one (equivalence effect demonstrated by p <0.0001 at Blackwelder test and an upper confidence limit at 97.5{\%} of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8 ± 0.2 versus 4.7 ± 0.5 days of therapy to reach the first day with satisfactory heartburn relief, p = 0.0045 at log-rank test). In the maintenance phase, 15.2{\%} of patients had an endoscopic and/or clinical relapse. Conclusion.: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.",
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author = "F. Pace and V. Annese and A. Prada and A. Zambelli and S. Casalini and P. Nardini and {Bianchi Porro}, G. and Z. Rossi and P. Fenderico and F. Molinari and A. Molinari and M. Poletti and A. Benedetti and L. Bolognini and P. Cercamondi and S. Piergallini and N. Pieroni and F. Ridolfi and A. Palazzi and A. Agnolucci and P. Ceccatelli and F. Laurenzi and M. Grassini and G. Iaquinto and V. D'Onofrio and N. Giardullo and L. Pasquale and A. Sedici and R. Moschetta and G. Maurogiovanni and Biedo Costan and B. Germana and P. Lecis and F. Negrini and S. Signorelli and P. Landi and P. Malaguti and E. Roda and Vergori De and L. Gandolfi and F. Torresan and F. Chilovi and S. Benvenuti and T. Grasso and S. Adamo and A. Sabatino and A. Anderloni and Mannucci, {P. M.} and Testoni, {P. A.} and A. Andriulli and {The Italian Rabeprazole Study Group}",
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TY - JOUR

T1 - Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole

AU - Pace, F.

AU - Annese, V.

AU - Prada, A.

AU - Zambelli, A.

AU - Casalini, S.

AU - Nardini, P.

AU - Bianchi Porro, G.

AU - Rossi, Z.

AU - Fenderico, P.

AU - Molinari, F.

AU - Molinari, A.

AU - Poletti, M.

AU - Benedetti, A.

AU - Bolognini, L.

AU - Cercamondi, P.

AU - Piergallini, S.

AU - Pieroni, N.

AU - Ridolfi, F.

AU - Palazzi, A.

AU - Agnolucci, A.

AU - Ceccatelli, P.

AU - Laurenzi, F.

AU - Grassini, M.

AU - Iaquinto, G.

AU - D'Onofrio, V.

AU - Giardullo, N.

AU - Pasquale, L.

AU - Sedici, A.

AU - Moschetta, R.

AU - Maurogiovanni, G.

AU - Costan, Biedo

AU - Germana, B.

AU - Lecis, P.

AU - Negrini, F.

AU - Signorelli, S.

AU - Landi, P.

AU - Malaguti, P.

AU - Roda, E.

AU - De, Vergori

AU - Gandolfi, L.

AU - Torresan, F.

AU - Chilovi, F.

AU - Benvenuti, S.

AU - Grasso, T.

AU - Adamo, S.

AU - Sabatino, A.

AU - Anderloni, A.

AU - Mannucci, P. M.

AU - Testoni, P. A.

AU - Andriulli, A.

AU - The Italian Rabeprazole Study Group

PY - 2005/10/1

Y1 - 2005/10/1

N2 - Background.: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. Aim.: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. Methods.: Patients (n = 560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2 × 10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. Results.: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p <0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8 ± 0.2 versus 4.7 ± 0.5 days of therapy to reach the first day with satisfactory heartburn relief, p = 0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. Conclusion.: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.

AB - Background.: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. Aim.: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. Methods.: Patients (n = 560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2 × 10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. Results.: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p <0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8 ± 0.2 versus 4.7 ± 0.5 days of therapy to reach the first day with satisfactory heartburn relief, p = 0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. Conclusion.: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.

KW - Curative/maintenance therapy

KW - Gastro-oesophageal reflux disease

KW - Heartburn

KW - Rabeprazole

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