Two doses of omeprazole versus placebo in symptomatic erosive esophagitis: The U.S. multicenter study

Sontag, Stephen J.; Hirschowitz, Basil I.; Holt, Shirley; Robinson, Malcolm; Behar, José; Berenson, Malcolm M.; McCullough, A; Ippoliti, Andrew; Richter, Joel E.; Ahtaridis, George; McCallum, Richard W.; Pambianco, Daniel J.; Vlahcevic, R.; Johnson, David A.; Collen, Martin J.; Lyon, David T.; Humphries, Thomas J.; Cagliola, A; Berman, Reuben

doi:10.1016/0016-5085(92)91790-b

Cited by 164 publications

(68 citation statements)

References 23 publications

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“…5 Clinical assessment of omeprazole in the treatment of erosive oesophagitis in a 230-patient multicenter US study con®rmed the ef®cacy of both 20 mg and 40 mg daily doses, but found no statistical difference between the two doses. 10 …”

Section: Previous Studiesmentioning

confidence: 99%

Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro‐oesophageal reflux disease

Robinson

Maton

Rodriguez

et al. 1997

Aliment Pharmacol Ther

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Background This study examined the dose–response effects of the new proton‐pump inhibitor rabeprazole on oesophageal and gastric pH in patients with gastro‐oesophageal reflux disease. Methods This study had a single‐centre, double‐blind, randomized, two‐way crossover design. Twenty patients were treated for two 7‐day periods separated by a 7–10‐day washout period. Patients were randomly assigned to receive either 20 mg of rabeprazole once daily during the first treatment period and 40 mg once daily during the second treatment period, or 40 mg during the first treatment period and 20 mg during the second treatment period. The primary efficacy variable was oesophageal acid exposure determined by 24‐hour ambulatory pH monitoring. Acid‐reflux time was defined as the percentage of time over 24 h that oesophageal pH was <4. A dosage was considered effective if reflux time was reduced to <6%, a number which has been our internal laboratory reference. Results Both rabeprazole 20 mg and 40 mg, given once daily, normalized reflux time, with decreases of 79% and 92% in acid exposure by day 7. Both dosages also decreased the mean total number of reflux episodes and the number of episodes lasting> 5 min, with no significant differences between dosages for any reflux parameter. Mean gastric pH increased with 20 mg from 1.86 at baseline to 3.71 on day 1 and 4.17 on day 7. Rabeprazole 40 mg once daily increased gastric pH from 2.01 to 4.37 on day 1, and to 4.65 on day 7. Safety analyses revealed no significant acute side‐effects for either dosage. Conclusions Pathological oesophageal acid exposure was normalized with both 20 mg and 40 mg dosages of rabeprazole, and the effects of these two doses did not differ. Rabeprazole was well‐tolerated in this short‐term study.

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Section: Previous Studiesmentioning

confidence: 99%

Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro‐oesophageal reflux disease

Robinson

Maton

Rodriguez

et al. 1997

Aliment Pharmacol Ther

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“…More recent clin-GERD symptom for at least 6 months prior to study enrollment and ical trials have demonstrated the superior clinical efficacy episodes of moderate to severe heartburn on at least 4 of the 7 days of omeprazole in maintenance therapy for reflux esophaprior to study enrollment. Both males and females (not pregnant, and gitis [15,16] and in poorly responsive GERD patients as not lactating) at least 18 years of age were eligible. Patients were determined by mucosal appearance [17].…”

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confidence: 99%

Health-Related Quality of Life Outcomes of Omeprazole versus Ranitidine in Poorly Responsive Symptomatic Gastroesophageal Reflux Disease

Revicki¹,

Sorensen

Maton

et al. 1998

Dig Dis

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Objective: This study evaluated changes in health-related quality of life (HRQL) outcomes of once-daily omeprazole compared with ranitidine for the short-term treatment of patients with poorly responsive symptomatic gastroesophageal reflux disease (GERD). Methods: A double-blind, randomized clinical trial, compared omeprazole versus ranitidine for the treatment of poorly responsive GERD. Eligible patients had a history of predominant heartburn symptoms with symptomatic heartburn after 6 weeks of ranitidine treatment. Patients were randomized to omeprazole 20 mg once daily (n = 156) or ranitidine 150 mg twice daily (n = 161) and followed for 8 weeks. Assessments were completed at baseline and after 8 weeks with physician-rated symptoms: Gastrointestinal Symptom Rating Scale (GSRS); Psychological General Well-Being (PGWB) Index; Sleep Scale; Impact on Daily Activities Scale, and Overall Treatment Effect. Primary HRQL endpoints were the GSRS reflux scale and PGWB total score. Results: No differences between the 2 treatment groups were observed in baseline demographic, clinical or HRQL measures. After 8 weeks, omeprazole-treated patients had greater improvement in GSRS reflux scale scores (p<0.0001) and PGWB total scores (p = 0.019) compared with ranitidine-treated patients. Significant between group differences favoring omeprazole were also observed in GSRS total scores (p<0.0001), abdominal pain scale scores (p = 0.003), and indigestion scale scores (p = 0.003), Impact on Daily Activities (p = 0.001), PGWB positive well-being (p = 0.015), anxiety (p = 0.030), and general health scale scores (p = 0.010). Patient ratings of overall treatment effect demonstrated the significantly (p<0.0001) greater benefits of omeprazole (mean = 5.26) compared with ranitidine treatment (mean = 3.83). Conclusions: Omeprazole treatment significantly reduced persistent reflux-related symptoms and normalized psychological well-being compared with ranitidine in poorly responsive symptomatic patients with GERD.

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“…One study demonstrated no difference in oesophagitis healing or symptom relief between standard-and high-dose omeprazole. 28 Two studies evaluated low-vs. standard-dose omeprazole for GERD symptom relief, with one showing similar efficacy and the other inferior efficacy. 20,25 In the healing of large gastric ulcers, high-dose omeprazole was superior to standard-dose omeprazole.…”

Section: Resultsmentioning

confidence: 99%

The Frontiers of Reflux Disease

Vakil

2006

Dig Dis Sci

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Two doses of omeprazole versus placebo in symptomatic erosive esophagitis: The U.S. multicenter study

Cited by 164 publications

References 23 publications

Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro‐oesophageal reflux disease

Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro‐oesophageal reflux disease

Health-Related Quality of Life Outcomes of Omeprazole versus Ranitidine in Poorly Responsive Symptomatic Gastroesophageal Reflux Disease

The Frontiers of Reflux Disease

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