Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis

A randomized, active-controlled, double-blind study

Thomas O.G. Kovacs, C. Mel Wilcox, Kenneth Devault, David Miska, Wieslaw Bochenek, Dennis Avner, William Berry, Mark Blitstein, Donald Campbell, James N. Cooper, Ralph A. Giannella, Norman Gitlin, Vernon Hee, David A. Johnson, Robert Kornfield, Peter Meier, Philip Miner, Rao Movva, John Orchard, John Person & 10 others Ronald Pruitt, Dennis Rift, John Rodgers, Alan Safdi, William B. Smith, William Snape, Stuart Weisman, Mirza Beg, Sue Dasen, Robert Nothington

    Research output: Contribution to journalArticle

    20 Citations (Scopus)

    Abstract

    Background: Pantoprazole is a proton pump inhibitor approved for the treatment of erosive oesophagitis and gastro-oesophageal reflux disease. Aim: To compare the efficacy and safety of pantoprazole vs. nizatidine for the treatment of symptomatic gastro-oesophageal reflux disease and endoscopically documented erosive oesophagitis (grade ≥ 2). Methods: A multicentre, double-blind, randomized, active-controlled study (221 patients) was performed to compare 20 and 40 mg pantoprazole daily with nizatidine 150 mg b.d. (maximum, 8 weeks). The primary end-point was endoscopic healing of erosive oesophagitis (grade 1 or 0). The secondary end-point was symptomatic improvement. Results: Healing averaged 61%, 64% and 22% for pantoprazole 20 mg, pantoprazole 40 mg and nizatidine 150 mg, respectively, at 4 weeks, and 79%, 83% and 41% at 8 weeks (P < 0.05, differences between groups at both points). Starting on day 1 of symptom assessment, significantly fewer pantoprazole-treated patients reported night-time heartburn and regurgitation compared with nizatidine-treated patients. Symptoms of gastro-oesophageal reflux disease were completely eliminated in 68% and 65% of patients in the pantoprazole 20-mg and 40-mg groups and in 28% of patients in the nizatidine group at study completion. The difference between each pantoprazole group and the nizatidine group was significant (P < 0.05). Conclusions: Pantoprazole, at single daily doses of 20 mg and 40 mg for up to 8 weeks, provides more rapid relief of symptoms and superior healing of erosive oesophagitis than nizatidine 150 mg b.d., and is well tolerated.

    Original languageEnglish (US)
    Pages (from-to)2043-2052
    Number of pages10
    JournalAlimentary Pharmacology and Therapeutics
    Volume16
    Issue number12
    DOIs
    StatePublished - Dec 1 2002

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    Nizatidine
    Esophagitis
    Double-Blind Method
    Esophageal Diseases
    Gastroesophageal Reflux
    Therapeutics
    pantoprazole
    Heartburn
    Symptom Assessment
    Proton Pump Inhibitors

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology
    • Pharmacology (medical)

    Cite this

    Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis : A randomized, active-controlled, double-blind study. / Kovacs, Thomas O.G.; Wilcox, C. Mel; Devault, Kenneth; Miska, David; Bochenek, Wieslaw; Avner, Dennis; Berry, William; Blitstein, Mark; Campbell, Donald; Cooper, James N.; Giannella, Ralph A.; Gitlin, Norman; Hee, Vernon; Johnson, David A.; Kornfield, Robert; Meier, Peter; Miner, Philip; Movva, Rao; Orchard, John; Person, John; Pruitt, Ronald; Rift, Dennis; Rodgers, John; Safdi, Alan; Smith, William B.; Snape, William; Weisman, Stuart; Beg, Mirza; Dasen, Sue; Nothington, Robert.

    In: Alimentary Pharmacology and Therapeutics, Vol. 16, No. 12, 01.12.2002, p. 2043-2052.

    Research output: Contribution to journalArticle

    Kovacs, TOG, Wilcox, CM, Devault, K, Miska, D, Bochenek, W, Avner, D, Berry, W, Blitstein, M, Campbell, D, Cooper, JN, Giannella, RA, Gitlin, N, Hee, V, Johnson, DA, Kornfield, R, Meier, P, Miner, P, Movva, R, Orchard, J, Person, J, Pruitt, R, Rift, D, Rodgers, J, Safdi, A, Smith, WB, Snape, W, Weisman, S, Beg, M, Dasen, S & Nothington, R 2002, 'Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis: A randomized, active-controlled, double-blind study', Alimentary Pharmacology and Therapeutics, vol. 16, no. 12, pp. 2043-2052. https://doi.org/10.1046/j.1365-2036.2002.01366.x
    Kovacs, Thomas O.G. ; Wilcox, C. Mel ; Devault, Kenneth ; Miska, David ; Bochenek, Wieslaw ; Avner, Dennis ; Berry, William ; Blitstein, Mark ; Campbell, Donald ; Cooper, James N. ; Giannella, Ralph A. ; Gitlin, Norman ; Hee, Vernon ; Johnson, David A. ; Kornfield, Robert ; Meier, Peter ; Miner, Philip ; Movva, Rao ; Orchard, John ; Person, John ; Pruitt, Ronald ; Rift, Dennis ; Rodgers, John ; Safdi, Alan ; Smith, William B. ; Snape, William ; Weisman, Stuart ; Beg, Mirza ; Dasen, Sue ; Nothington, Robert. / Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis : A randomized, active-controlled, double-blind study. In: Alimentary Pharmacology and Therapeutics. 2002 ; Vol. 16, No. 12. pp. 2043-2052.
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    abstract = "Background: Pantoprazole is a proton pump inhibitor approved for the treatment of erosive oesophagitis and gastro-oesophageal reflux disease. Aim: To compare the efficacy and safety of pantoprazole vs. nizatidine for the treatment of symptomatic gastro-oesophageal reflux disease and endoscopically documented erosive oesophagitis (grade ≥ 2). Methods: A multicentre, double-blind, randomized, active-controlled study (221 patients) was performed to compare 20 and 40 mg pantoprazole daily with nizatidine 150 mg b.d. (maximum, 8 weeks). The primary end-point was endoscopic healing of erosive oesophagitis (grade 1 or 0). The secondary end-point was symptomatic improvement. Results: Healing averaged 61{\%}, 64{\%} and 22{\%} for pantoprazole 20 mg, pantoprazole 40 mg and nizatidine 150 mg, respectively, at 4 weeks, and 79{\%}, 83{\%} and 41{\%} at 8 weeks (P < 0.05, differences between groups at both points). Starting on day 1 of symptom assessment, significantly fewer pantoprazole-treated patients reported night-time heartburn and regurgitation compared with nizatidine-treated patients. Symptoms of gastro-oesophageal reflux disease were completely eliminated in 68{\%} and 65{\%} of patients in the pantoprazole 20-mg and 40-mg groups and in 28{\%} of patients in the nizatidine group at study completion. The difference between each pantoprazole group and the nizatidine group was significant (P < 0.05). Conclusions: Pantoprazole, at single daily doses of 20 mg and 40 mg for up to 8 weeks, provides more rapid relief of symptoms and superior healing of erosive oesophagitis than nizatidine 150 mg b.d., and is well tolerated.",
    author = "Kovacs, {Thomas O.G.} and Wilcox, {C. Mel} and Kenneth Devault and David Miska and Wieslaw Bochenek and Dennis Avner and William Berry and Mark Blitstein and Donald Campbell and Cooper, {James N.} and Giannella, {Ralph A.} and Norman Gitlin and Vernon Hee and Johnson, {David A.} and Robert Kornfield and Peter Meier and Philip Miner and Rao Movva and John Orchard and John Person and Ronald Pruitt and Dennis Rift and John Rodgers and Alan Safdi and Smith, {William B.} and William Snape and Stuart Weisman and Mirza Beg and Sue Dasen and Robert Nothington",
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    T1 - Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis

    T2 - A randomized, active-controlled, double-blind study

    AU - Kovacs, Thomas O.G.

    AU - Wilcox, C. Mel

    AU - Devault, Kenneth

    AU - Miska, David

    AU - Bochenek, Wieslaw

    AU - Avner, Dennis

    AU - Berry, William

    AU - Blitstein, Mark

    AU - Campbell, Donald

    AU - Cooper, James N.

    AU - Giannella, Ralph A.

    AU - Gitlin, Norman

    AU - Hee, Vernon

    AU - Johnson, David A.

    AU - Kornfield, Robert

    AU - Meier, Peter

    AU - Miner, Philip

    AU - Movva, Rao

    AU - Orchard, John

    AU - Person, John

    AU - Pruitt, Ronald

    AU - Rift, Dennis

    AU - Rodgers, John

    AU - Safdi, Alan

    AU - Smith, William B.

    AU - Snape, William

    AU - Weisman, Stuart

    AU - Beg, Mirza

    AU - Dasen, Sue

    AU - Nothington, Robert

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    N2 - Background: Pantoprazole is a proton pump inhibitor approved for the treatment of erosive oesophagitis and gastro-oesophageal reflux disease. Aim: To compare the efficacy and safety of pantoprazole vs. nizatidine for the treatment of symptomatic gastro-oesophageal reflux disease and endoscopically documented erosive oesophagitis (grade ≥ 2). Methods: A multicentre, double-blind, randomized, active-controlled study (221 patients) was performed to compare 20 and 40 mg pantoprazole daily with nizatidine 150 mg b.d. (maximum, 8 weeks). The primary end-point was endoscopic healing of erosive oesophagitis (grade 1 or 0). The secondary end-point was symptomatic improvement. Results: Healing averaged 61%, 64% and 22% for pantoprazole 20 mg, pantoprazole 40 mg and nizatidine 150 mg, respectively, at 4 weeks, and 79%, 83% and 41% at 8 weeks (P < 0.05, differences between groups at both points). Starting on day 1 of symptom assessment, significantly fewer pantoprazole-treated patients reported night-time heartburn and regurgitation compared with nizatidine-treated patients. Symptoms of gastro-oesophageal reflux disease were completely eliminated in 68% and 65% of patients in the pantoprazole 20-mg and 40-mg groups and in 28% of patients in the nizatidine group at study completion. The difference between each pantoprazole group and the nizatidine group was significant (P < 0.05). Conclusions: Pantoprazole, at single daily doses of 20 mg and 40 mg for up to 8 weeks, provides more rapid relief of symptoms and superior healing of erosive oesophagitis than nizatidine 150 mg b.d., and is well tolerated.

    AB - Background: Pantoprazole is a proton pump inhibitor approved for the treatment of erosive oesophagitis and gastro-oesophageal reflux disease. Aim: To compare the efficacy and safety of pantoprazole vs. nizatidine for the treatment of symptomatic gastro-oesophageal reflux disease and endoscopically documented erosive oesophagitis (grade ≥ 2). Methods: A multicentre, double-blind, randomized, active-controlled study (221 patients) was performed to compare 20 and 40 mg pantoprazole daily with nizatidine 150 mg b.d. (maximum, 8 weeks). The primary end-point was endoscopic healing of erosive oesophagitis (grade 1 or 0). The secondary end-point was symptomatic improvement. Results: Healing averaged 61%, 64% and 22% for pantoprazole 20 mg, pantoprazole 40 mg and nizatidine 150 mg, respectively, at 4 weeks, and 79%, 83% and 41% at 8 weeks (P < 0.05, differences between groups at both points). Starting on day 1 of symptom assessment, significantly fewer pantoprazole-treated patients reported night-time heartburn and regurgitation compared with nizatidine-treated patients. Symptoms of gastro-oesophageal reflux disease were completely eliminated in 68% and 65% of patients in the pantoprazole 20-mg and 40-mg groups and in 28% of patients in the nizatidine group at study completion. The difference between each pantoprazole group and the nizatidine group was significant (P < 0.05). Conclusions: Pantoprazole, at single daily doses of 20 mg and 40 mg for up to 8 weeks, provides more rapid relief of symptoms and superior healing of erosive oesophagitis than nizatidine 150 mg b.d., and is well tolerated.

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