Lansoprazole versus Omeprazole in Short-Term Treatment of Reflux Oesophagitis Results of a Scandinavian Multicentre Trial

Jg, Hatlebakk; Berstad, Arnold; Carling, L; Le, Scheving; Unge, Peter; Ekström, Per; Halvorsen, Lars; Stallemo, Asbjørn; Hovdenak, Nils; R, Trondstad

doi:10.3109/00365529309096076

Cited by 120 publications

(78 citation statements)

References 8 publications

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“…4,10 The overall safety pro®le in this study was similar to the pro®le of events for clinical trials with lansoprazole (as illustrated in Table 6) and similar to the pro®le of an analysis of 68 clinical trials with omeprazole. 1,11 In general, the adverse events during lansoprazole use were mild and self-limiting.…”

Section: Discussionsupporting

confidence: 69%

A prospective follow‐up study of 5669 users of lansoprazole in daily practice

Leufkens

Claessens

Heerdink

et al. 1997

Aliment Pharmacol Ther

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Background: Immediately after the introduction of the proton pump inhibitor lansoprazole, a 2‐year follow‐up study was started to evaluate patterns of use, safety and effectiveness of this drug in naturally occurring groups of patients in the Netherlands. Medical data were recorded by participating physicians while medication listings were provided by pharmacists. Methods: The study was designed according to the Safety Assessment of Marketed Medicines guidelines. The only inclusion criterion was the use of lansoprazole prior to entry into the study. Results: A total of 5669 lansoprazole users was included by 374 general practitioners and 117 specialists. Lansoprazole was mostly prescribed in patients with reflux oesophagitis (55.1%), `gastritis' (26.8%) and duodenal ulcers (11.4%), sometimes as part of a Helicobacter pylori eradication therapy (8.5%). For their complaints most patients (91.1%) had previously used acid‐related drugs. Improvement or disappearance of complaints was achieved in 88.9% and 90.5% of patients after 4 and 8 weeks of treatment, respectively. Diarrhoea (4.1%), headache (2.9%) and nausea (2.6%) were the most frequently reported adverse events. Conclusion: The patterns of use of lansoprazole in daily practice deviated from the recommendations in the information leaflet. Nevertheless, lansoprazole was found to be safe in this naturally occurring group of users. Effectiveness appeared to be comparable to results found in clinical trials of the registered indications for lansoprazole.

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Section: Discussionsupporting

confidence: 69%

A prospective follow‐up study of 5669 users of lansoprazole in daily practice

Leufkens

Claessens

Heerdink

et al. 1997

Aliment Pharmacol Ther

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“…Endoscopic grade of re¯ux oesophagitis is a signi®cant prognostic factor for healing with lansoprazole 12 and other antisecretory therapy, but did not signi®cantly (P 0.09) predict time to clinical relapse in the present study. This may possibly be due to the limited number of patients (type 2 error) and to the fact that the patients studied were already selected as healing on lansoprazole therapy.…”

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confidence: 48%

Prognostic factors for relapse of reflux oesophagitis and symptoms during 12 months of therapy with lansoprazole

Hatlebakk

Berstad

1997

Aliment Pharmacol Ther

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Background:Symptom relief and endoscopic healing are both important treatment goals in patients with reflux oesophagitis. Knowledge of predictive factors for treatment success could facilitate choice of treatment in individual patients.Aim:To assess the value of clinical data and data from baseline ancillary investigations in predicting the outcome of maintenance therapy with a proton pump inhibitor.Methods:After healing and symptom relief had been obtained on open therapy with lansoprazole 30 mg daily, 103 patients with reflux oesophagitis grade 1 or 2 were randomized to maintenance therapy with lansoprazole 15 or 30 mg daily, and time until recurrence of symptoms and/or endoscopic changes was recorded. The predictive value of the following variables was assessed by Cox regression analysis: dose of lansoprazole, symptom severity, grade of reflux oesophagitis, Helicobacter pylori infection status, lower oesophageal sphincter resting tone, percentage of 24 h with an oesophageal pH of <4.0, and median 24 h intragastric pH before start of treatment.Results:Dose of lansoprazole (P = 0.01) and symptom severity (P < 0.05) both significantly predicted time to relapse. Grade of reflux oesophagitis had only a borderline predictive value (P = 0.09), while H. pylori infection status and data from manometry and intraoesophageal 24‐hour pH‐metry did not predict relapse.Conclusions:Symptom severity before starting therapy is a significant predictive factor for treatment success during potent antisecretory therapy with lansoprazole, more so than endoscopic grade of reflux oesophagitis. In a group of patients with uncomplicated reflux oesophagitis being considered for maintenance therapy with lansoprazole, ancillary investigations with endoscopy, manometry and 24‐hour pH‐metry gave very limited prognostic information. H. pylori infected patients relapsed as early as patients who were not infected.

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“…Omeprazole, a proton-pump criteria were entered into the open-label phase of the study. Patients inhibitor, is more effective than placebo in healing esoph-were recruited from 32 US centers, which included gastroenterology agitis [6,13] and is more effective than an H 2 -receptor and family medicine practices. Eligibility criteria for the open-label phase of the study were a history of heartburn as the predominant antagonist for severe esophagitis [6,14].…”

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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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Lansoprazole versus Omeprazole in Short-Term Treatment of Reflux Oesophagitis Results of a Scandinavian Multicentre Trial

Cited by 120 publications

References 8 publications

A prospective follow‐up study of 5669 users of lansoprazole in daily practice

A prospective follow‐up study of 5669 users of lansoprazole in daily practice

Prognostic factors for relapse of reflux oesophagitis and symptoms during 12 months of therapy with lansoprazole

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

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