High- Versus standard-dose ranitidine for control of heartburn in poorly responsive acid reflux disease: A prospective, controlled trial

Peter J. Kahrilas, M (Brian) Fennerty, Bo Joelsson

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Abstract

Objective: H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERD patients who remained symptomatic after 6 wk of therapy with ranitidine 150 mg b.i.d. Methods: This was a two-phase, prospective study. In the first phase, GERD patients with heartburn on ≥ 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. Results: Of the 481 patients treated for 6 wk in phase I, 285 (59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double- blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20% of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. Conclusions: These results indicate that the majority of GERD patients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.

Original languageEnglish (US)
Pages (from-to)92-97
Number of pages6
JournalAmerican Journal of Gastroenterology
Volume94
Issue number1
DOIs
StatePublished - Jan 1999

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Heartburn
Ranitidine
Acids
Gastroesophageal Reflux
Therapeutics
Histamine H2 Receptors
Prospective Studies

ASJC Scopus subject areas

  • Gastroenterology

Cite this

@article{ed6c1350efe34a01a48b8aee137b45b9,
title = "High- Versus standard-dose ranitidine for control of heartburn in poorly responsive acid reflux disease: A prospective, controlled trial",
abstract = "Objective: H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERD patients who remained symptomatic after 6 wk of therapy with ranitidine 150 mg b.i.d. Methods: This was a two-phase, prospective study. In the first phase, GERD patients with heartburn on ≥ 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. Results: Of the 481 patients treated for 6 wk in phase I, 285 (59{\%}) were still symptomatic; 271 patients (95{\%} of those still symptomatic) were randomized to double- blind treatment with ranitidine. In phase II, 45{\%} of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20{\%} of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. Conclusions: These results indicate that the majority of GERD patients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.",
author = "Kahrilas, {Peter J.} and Fennerty, {M (Brian)} and Bo Joelsson",
year = "1999",
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T1 - High- Versus standard-dose ranitidine for control of heartburn in poorly responsive acid reflux disease

T2 - A prospective, controlled trial

AU - Kahrilas, Peter J.

AU - Fennerty, M (Brian)

AU - Joelsson, Bo

PY - 1999/1

Y1 - 1999/1

N2 - Objective: H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERD patients who remained symptomatic after 6 wk of therapy with ranitidine 150 mg b.i.d. Methods: This was a two-phase, prospective study. In the first phase, GERD patients with heartburn on ≥ 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. Results: Of the 481 patients treated for 6 wk in phase I, 285 (59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double- blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20% of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. Conclusions: These results indicate that the majority of GERD patients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.

AB - Objective: H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERD patients who remained symptomatic after 6 wk of therapy with ranitidine 150 mg b.i.d. Methods: This was a two-phase, prospective study. In the first phase, GERD patients with heartburn on ≥ 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. Results: Of the 481 patients treated for 6 wk in phase I, 285 (59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double- blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20% of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. Conclusions: These results indicate that the majority of GERD patients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.

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