Double-blind trial of omeprazole and amoxicillin to cure Helicobacter pylori infection in patients with duodenal ulcers

Bayerdörffer, Ekkehard; Miehlke, Stephan; Mannes, G. A.; Sommer, Albrecht; Höchter, W.; Weingart, J; Heldwein, Walter; Klann, Hermann; Simon, Thomas; Schmitt, Wolfgang; Bästlein, Elke; Eimiller, A.; Hatz, Rudolf; Lehn, Norbert; Dirschedl, P.; Stolte, Manfred

doi:10.1016/0016-5085(95)90689-4

Cited by 192 publications

(142 citation statements)

References 32 publications

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“…The high-dose AMX (3 g/day) 10 days' treatment was adopted from the 'old' dual therapy which was reported with a high cure rate (>90%) in the early years of H. pylori treatment. 36,37 However, the dual therapy only achieved a 67% cure rate in one of our earlier trials. 38 As a result, RFB and a quinolone, a method adopted from Wong WM et al, 34 were combined with the dual therapy to improve the cure rate.…”

Section: Discussionmentioning

confidence: 95%

Helicobacter pylori eradication in Western Australia using novel quadruple therapy combinations

Tay

Windsor

Thirriot

et al. 2012

Aliment Pharmacol Ther

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Section: Discussionmentioning

confidence: 95%

Helicobacter pylori eradication in Western Australia using novel quadruple therapy combinations

Tay

Windsor

Thirriot

et al. 2012

Aliment Pharmacol Ther

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“…[2][3][4][5][6] Figure 2 shows that baseline concentrations of omeprazole and daily regimen, the plasma clearance of omeprazole was increased from 5.8 L/h to 7.9 L/h, and, correspondingly, 5 -hydroxyomeprazole were reached before the next 60-mg dose. The mean residual concentration of omepra-AUC increased less than dose-proportionally from 18.1 mmolrh/L to 21.9 mmolrh/L; CYP3A-dependent clear-zole sulfone amounts to only 1.0 mmol/L.…”

Section: Comparison Of Omeprazole Kinetics Between Emsmentioning

confidence: 99%

“…2,6 Thus far, omeprazole kinetics were were investigated after treatment with repeated high studied upon single doses of 10 to 80 mg [7][8][9][10][11] Two major primary metabolites, omeprazole sulfone that CYP2C19-dependent plasma clearance of omepra-and 5 -hydroxyomeprazole, are formed by cytochromes zole and omeprazole sulfone was reduced from 19.0 to P450 3A (CYP3A) and 2C19 (CYP2C19), respectively 8.4 L/h (P õ .001) and from 19.8 to 9.2 L/h (P Å .012), (Fig. 1).…”

mentioning

confidence: 99%

Nonlinear Kinetics After High–Dose Omeprazole Caused by Saturation of Genetically Variable Cyp2c19

Rost¹,

Roots²

1996

Hepatology

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Nonlinear kinetics of omeprazole and its metabolites bacter pylori. 2,6 Thus far, omeprazole kinetics were were investigated after treatment with repeated high studied upon single doses of 10 to 80 mg [7][8][9][10][11] Two major primary metabolites, omeprazole sulfone that CYP2C19-dependent plasma clearance of omepra-and 5 -hydroxyomeprazole, are formed by cytochromes zole and omeprazole sulfone was reduced from 19.0 to P450 3A (CYP3A) and 2C19 (CYP2C19), respectively 8.4 L/h (P õ .001) and from 19.8 to 9.2 L/h (P Å .012), (Fig. 1). Both metabolites undergo further metabolism respectively. Similarly, formation half-life of 5 -hydroxy-to the common metabolite 5 -hydroxyomeprazole sulomeprazole increased from 0.58 to 1.45 hours (P Å .025) fone via CYP2C19 and CYP3A, respectively. 14-16 Thus, with the higher dose. CYP3A-dependent metabolic both CYP enzymes are sequentially-but alternaroutes remained unaffected. Thus, high-dose treatment tively-involved in omeprazole metabolism. CYP2C19, the area under the plasma concentration-time curve (AUC) of omeprazole 8,10,17,18 in comparison with extenThe irreversible H / , K / -adenosine triphosphatase in-sive metabolizers (EMs). The latter represent 96 to 97% hibitor omeprazole is successfully used in various gas-of a Caucasian, but only about 80% of a Far Eastern tric acid-related disorders. It is a generally well-toler-population. 19,20 A hereditary deficiency of the alternaated drug, even in long-term treatment. 1,2 Changes in tive enzyme, CYP3A, has not been shown. gastrointestinal cell structure and function remain lim-The clinical necessity to apply high omeprazole doses ited. 3 Clinical doses range from 20 to 40 mg/d for the may create concerns of exceedingly high omeprazole treatment of gastric and duodenal ulcers, 20 to 80 mg/d concentrations that may result from nonlinear (saturafor reflux esophagitis, and 20 to 120 mg/d for Zollinger-tion) kinetics. Moreover, in PMs, elimination of omeEllison syndrome 2-5 or in the eradication of Helico-prazole is confined to CYP3A activity. Especially in those genetically defined patients, omeprazole elimination might be impaired drastically, if CYP3A activity is inhibited by comedication, e.g., by macrolides such Abbreviations: CYP3A, cytochrome P450 3A; CYP2C19, cytochrome P450 2C19; PMs, poor metabolizers; AUC, area under the plasma concentrationas erythromycin or antifungals such as ketoconazole. 17 time curve; EMs, extensive metabolizers.We evaluated omeprazole plasma kinetics after treat- kinetics of 40 mg once daily in EMs and PMs. MetaboReceived September 25, 1995; accepted February 9, 1996. lite patterns are evaluated to distinguish CYP2C19 and Address reprint requests to Karl Ludwig Rost, M.D., Institut fü r Klinische CYP3A activity with respect to dose linearity.

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“…Therapy with amoxicillin associated with omeprazole was reported to eradicate infection in more than 80% of patients, with lower side effect rates and cost (12). The recurrence rate after HP eradication in adult patients in Brazil is still unknown.…”

mentioning

confidence: 99%

Eradication of Helicobacter pylori infection in patients with duodenal ulcer and non-ulcer dyspepsia and analysis of one-year reinfection rates

Líbera

Röhr

Moraes

et al. 2001

Braz J Med Biol Res

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Helicobacter pylori (HP) infection is endemic worldwide. The proposed treatment is expensive and there are few reports regarding reinfection rates in Brazil. The aim of this study was to compare the eradication rates obtained with two therapeutic options and to evaluate reinfection one year after treatment. This was a prospective randomized trial with 55 patients. Thirty-nine patients had active duodenal ulcer (DU) and 16 non-ulcer dyspepsia (NUD), and all tested positive for HP. Diagnosis was based on at least two positive tests: ultrarapid urease test, histology and/or culture. Patients were randomized to two groups: group OMC treated with 40 mg omeprazole (once a day), 500 mg metronidazole and 250 mg clarithromycin (twice daily) for 7 days, or group NA treated with 300 mg nizatidine (once a day) and 1000 mg amoxicillin (twice daily) for 14 days. Those patients in whom HP was eradicated were followed up for one year to evaluate reinfection. Twenty-five patients were randomized for OMC and 30 for NA. HP eradication occurred in 20/25 patients (80%) treated with OMC and 13/30 (43%) treated with NA (P = 0.01). After reallocation because of initial treatment failure, the overall eradication rate was 44/51 patients (86%). After an average follow-up of one year, we evaluated 34 patients (23 with DU and 11 with NUD). Reinfection occurred in 3/34 patients (7.6%). We conclude that OMC is effective for HP eradication, and that NA should not be used. Reinfection occurs in 7.6% of the patients in the first year after eradication.

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Double-blind trial of omeprazole and amoxicillin to cure Helicobacter pylori infection in patients with duodenal ulcers

Cited by 192 publications

References 32 publications

Helicobacter pylori eradication in Western Australia using novel quadruple therapy combinations

Helicobacter pylori eradication in Western Australia using novel quadruple therapy combinations

Nonlinear Kinetics After High–Dose Omeprazole Caused by Saturation of Genetically Variable Cyp2c19

Eradication of Helicobacter pylori infection in patients with duodenal ulcer and non-ulcer dyspepsia and analysis of one-year reinfection rates

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