Evidence Table 5

Non-erosive gastroesophageal reflux disease relapse prevention

Population, settingHeartburn severity, other characteristicsNumber screened, eligible, enrolled, withdrawn, lost to followupResultsQuality ratingFunding source and role of funder
Bytzer et al., 2004535 patients at centers in Greece, Italy, the Netherlands, Spain, France, Portugal, Sweden, Denmark, Ireland, Belgium, United Kingdom, Russia, Poland and Lithuania; mean age: 47; 60% female; ethnicity not givenPatient assessment of heartburn severity scored on 5-point Likert scale; Quality of life assessed with 22-item Psychological General Well-being Index (PGWBI); 100% patients previously achieved complete relief of symptoms during acute treatment phase668 screened

Acute phase: 535 enrolled, 117 withdrawn, 5 lost to followup

On-demand phase: 418 enrolled, 71 withdrawn, 9 lost to followup
Complete relief of symptoms at acute phase by 4 weeks:
rabeprazole 10 mg: 83%

Discontinuation due to lack of heartburn control during on-demand phase by 6 months:
rabeprazole 10 mg: 6%
placebo: 20%

p < 0.00001
FairSupported by Janssen
Talley, et al., 2001342 patients in 65 centers in Denmark, Finland, Norway and Sweden; mean age: 49; 56% male; ethnicity not givenHeartburn frequency and severity, and severity of related gastrointestinal symptoms with assessed with standardized checklist; 100% patients previously achieved complete relief of symptoms during acute treatment phase342 enrolled, 123 withdrawn, 2 lost to followupDiscontinuation due to lack of heartburn control during on-demand phase by 6 months:
esomeprazole 20 mg: 14%
placebo: 51%

Mean number of days patients remained with on- demand therapy:
esomeprazole 20 mg: 165
placebo: 119
FairSupported by AstraZeneca
Tsai et al., 2004774 enrolled patients, of whom 152 withdrew prior to randomization in 92 general practices and 28 hospitals with at least a 6 mo history of heartburn, including 4 of 7 days preceding study entry and no esophageal mucosal breaks verified by endoscopy up to 14 days prior to enrollment.
Patient characteristics: mean age 51.3 yrs; 56% female; ethnicity NR
Severity of heartburn at baseline:
Mild: 26.6% (n=195)
Moderate: 59% (n=452)
Severe: 15.4% (n=118)
(n=765 total)
774 enrolled, 152 discontinued prior to randomization into maintenance phase of study, including 18 withdrawals due to AEs, 124 who did not meet eligibility and 10 for other reasons not specified.
622 randomized into maintenance phase, 80 withdrawals during maintenance phase due to adverse event, heartburn or other unspecified reason.
More lansoprazole 15 mg continuous use vs esomeprazole 20 mg on-demand unwilling to continue use at 6 mos (13% v 6%; p=0.001; 95% CI 9.2–16.8 and 2.8–8.8 respectively.) More esomeprazole patients were satisfied (score of 1–4 on Treatment Satisfaction Questionnaire) at 1 mo compared to lansoprazole patients (93.2% v 87.8%, p=0.02 95% CI 0.88–10.1) The difference in patient satisfaction between the treatment groups lessened at 3 and 6 mos, but exact percentages are not provided in the study.FairSupported by Astra-Zeneca

From: Evidence Tables

Cover of Drug Class Review: Proton Pump Inhibitors
Drug Class Review: Proton Pump Inhibitors: Final Report Update 5 [Internet].
McDonagh MS, Carson S, Thakurta S.
Portland (OR): Oregon Health & Science University; 2009 May.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

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