A Prospective, Randomized Study of Quadruple Therapy and High‐Dose Dual Therapy for Treatment of <i>Helicobacter Pylori</i> Resistant to Both Metronidazole and Clarithromycin

Miehlke, Stephan; Kirsch, Christian; Schneider-Brachert, Wulf; Haferland, Christian; Neumeyer, Michael; Bästlein, Elke; Papke, Jens; Jacobs, Enno; Vieth, Michael; Stolte, Manfred; Lehn, Norbert; Bayerdörffer, Ekkehard

doi:10.1046/j.1523-5378.2003.00158.x

Cited by 106 publications

(137 citation statements)

References 49 publications

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“…We found eleven RCTs, published since 2000, that had compared 14-day bismuth quadruple therapy with other regimens as salvage treatment; one was conducted in the United States ( 177 ), three in Europe ( 175,176,178 ) and the remaining seven in Asia ( 173,(179)(180)(181)(182)(183)(184). Eight of these studies only included patients who failed eradication once, aft er treatment with clarithromycin triple therapy.…”

Section: Bismuth-quadruple Regimenmentioning

confidence: 99%

“…amoxicillin dosing) with other regimens as salvage treatments ( 178,203,206 ). Two of these studies have been conducted in Germany, both by Miehlke et al Th e fi rst study included 84 patients with at least one previous treatment failure (most patients had two or more treatment failures) and compared 14-day high-dose dual therapy (omeprazole 40 mg and amoxicillin 750 mg, both given q.i.d .)…”

Section: Clarithromycin Triple Therapymentioning

confidence: 99%

“…with 14-day bismuth quadruple treatment. Th e eradication rates for the two regimens did not diff er signifi cantly (dual therapy: 76%, 95% CI: 60-88%, vs. bismuth quadruple therapy: 81%, 67-92%) ( 178 ). Th e second study included 145 patients with at least one previous eradication failure and dual H. pylori resistance to metronidazole and clarithromycin who were randomized to high-dose dual therapy for 14 days or rifabutin triple therapy for 7 days.…”

Section: Clarithromycin Triple Therapymentioning

confidence: 99%

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ACG Clinical Guideline: Treatment of Helicobacter pylori Infection

Chey

Leontiadis

Howden

et al. 2017

American Journal of Gastroenterology

1,266

1,505

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Helicobacter pylori ( H. pylori ) infection is a common worldwide infection that is an important cause of peptic ulcer disease and gastric cancer. H. pylori may also have a role in uninvestigated and functional dyspepsia, ulcer risk in patients taking low-dose aspirin or starting therapy with a non-steroidal anti-infl ammatory medication, unexplained iron defi ciency anemia, and idiopathic thrombocytopenic purpura. While choosing a treatment regimen for H. pylori , patients should be asked about previous antibiotic exposure and this information should be incorporated into the decision-making process. For fi rst-line treatment, clarithromycin triple therapy should be confi ned to patients with no previous history of macrolide exposure who reside in areas where clarithromycin resistance amongst H. pylori isolates is known to be low. Most patients will be better served by fi rst-line treatment with bismuth quadruple therapy or concomitant therapy consisting of a PPI, clarithromycin, amoxicillin, and metronidazole. When fi rst-line therapy fails, a salvage regimen should avoid antibiotics that were previously used. If a patient received a fi rst-line treatment containing clarithromycin, bismuth quadruple therapy or levofl oxacin salvage regimens are the preferred treatment options. If a patient received fi rst-line bismuth quadruple therapy, clarithromycin or levofl oxacin-containing salvage regimens are the preferred treatment options. Details regarding the drugs, doses and durations of the recommended and suggested fi rst-line and salvage regimens can be found in the guideline. Asia and Central and South America ( 8,22 ). Th ere is, however, preliminary evidence that it may be falling in some previously high prevalence areas ( 22 ). People immigrating to North America from Asia and other parts of the world have a much higher prevalence of the infection than people born in North America ( 23 ). In one study, the seroprevalence among immigrants from East Asia was 70.1% ( 24 ). Hispanic immigrants to North America have higher rates of the infection than fi rst-or second-generation Hispanics who were born here ( 25 ). QUESTION 2: WHAT ARE THE INDICATIONS TO TEST FOR, AND TO TREAT, H. PYLORI INFECTION? RecommendationsSince all patients with a positive test of active infection with H. pylori should be off ered treatment, the critical issue is which patients should be tested for the infection (strong recommendation, quality of evidence: not applicable), All patients with active peptic ulcer disease (PUD), a past history of PUD (unless previous cure of H. pylori infection has been documented), low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma, or a history of endoscopic resection of early gastric cancer (EGC) should be tested for H. pylori infection. Th ose who test positive should be off ered treatment for the infection (strong recommendation, quality of evidence: high for active or history of PUD, low for MALT lymphoma, low for history of endoscopic resection of EGC).In patients with uninvestigated d...

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Section: Bismuth-quadruple Regimenmentioning

confidence: 99%

Section: Clarithromycin Triple Therapymentioning

confidence: 99%

Section: Clarithromycin Triple Therapymentioning

confidence: 99%

See 1 more Smart Citation

ACG Clinical Guideline: Treatment of Helicobacter pylori Infection

Chey

Leontiadis

Howden

et al. 2017

American Journal of Gastroenterology

1,266

1,505

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“…In a recent study, patients with at least one treatment failure who were infected with H pylori resistant to both metronidazole and clarithromycin, were treated with high doses of omeprazole (4 × 40 mg) and amoxicillin (4 × 750 mg) for 14 d, and the infection was cured in 76% of the cases [160] . This study suggests that, although the "old-fashioned" dual combination of omeprazole plus amoxicillin is generally considered quite ineffective as a first-line regimen, it may be associated with relatively good results if prescribed at high doses, even for H pylori resistant to both metronidazole and clarithromycin, in patients who experienced previous treatment failures.…”

Section: Amoxicillin ± Tetracycline-based Regimensmentioning

confidence: 99%

“Rescue” regimens after Helicobacter pylori treatment failure

Gisbert¹

2008

WJG

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Helicobacter pylori (H pylori ) infection is the main cause of gastritis, gastroduodenal ulcer disease, and gastric cancer. After more than 20 years of experience in H pylori treatment, in my opinion, the ideal regimen to treat this infection is still to be found. Currently, apart from having to know first-line eradication regimens well, we must also be prepared to face treatment failures. Therefore, in designing a treatment strategy we should not focus on the results of primary therapy alone, but also on the final (overall) eradication rate. The choice of a "rescue" treatment depends on which treatment is used initially. If a clarithromycinbased regimen was used initially, a subsequent metronidazole-based treatment (quadruple therapy) may be used afterwards, and then a levofloxacinbased combination would be a third "rescue" option. Alternatively, it has recently been suggested that levofloxacin-based rescue therapy constitutes an encouraging second-line strategy, representing an alternative to quadruple therapy in patients with previous PPI-clarithromycin-amoxicillin failure, with the advantage of efficacy, simplicity and safety. In this case, a quadruple regimen may be reserved as a third-line rescue option. Finally, rifabutin-based rescue therapy constitutes an encouraging empirical fourthline strategy after multiple previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, tetracycline, and levofloxacin. Even after two consecutive failures, several studies have demonstrated that H pylori eradication can finally be achieved in almost all patients if several rescue therapies are consecutively given. Therefore, the attitude in H pylori eradication therapy failure, even after two or more unsuccessful attempts, should be to fight and not to surrender.

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“…naproxen) (Goldstein et al, 2010), Aspirin (Chan et al, 2005), metronidazole and clarithromycin (Miehlke et al, 2003) or amoxicillin (Graham et al, 2006). As the PPI developed for the treatment of acidrelated diseases (Andersson et al, 2001), esomeprazole, the S-isomer of omeprazole, owes higher bioavailability and so the stronger acid inhibitor effect.…”

Section: Introductionmentioning

confidence: 99%

Preparation and in vitro/in vivo evaluation of esomeprazole magnesium-modified release pellets

et al. 2014

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To reduce the drug plasma concentration fluctuation without being destroyed by gastric fluid, novel Esomeprazole magnesium modified-release pellets (EMZ-MRPs) with suitable in vitro release profiles and good in vitro and in vivo correlation (IVIVC) were developed. Fluid-bed was used to obtain EMZ-loaded pellets by spraying drug suspension onto blank sugar pellets. The drug-loaded pellets were subsequently coated with Eudragit Õ RS30D/RL30D (ERS/ERL) aqueous dispersion to achieve sustained-release (SR) characteristics. Furthermore, the SR pellets were coated with Eudragit Õ L30D-55 (EL-55) aqueous dispersion to achieve enteric properties. Besides, isolated coating film was necessary between drug layer and SR layer, as well as SR and enteric-coated layer to protect from their possible reaction. The resulting pellets were filled into the hard gelatin capsules for in vitro release processing and single-dose pharmacokinetic study in rats. The optimal formulation achieved good SR feature both in vitro and in vivo with a relative bioavailability of 103.50%. A good IVIVC was characterized by a high coefficient of determination (r ¼ 0.9945) by deconvolution method. Compared to those of EMZ entericcoated pellets (EMZ-ECPs, trade name NEXIUM), the in vivo study make known that the EMZ-MRPs with decreased maximum plasma concentration (C max ), prolonged peak concentration time (T max ) and mean residence time (MRT), and similar values both area under concentration-time curve from 0 to t (AUC 0-t ) and 0 to infinity (AUC 0-1 ). Collectively, these results manifested EMZ-MRPs had a satisfactory sustained-release behavior, a desired pharmacokinetic property, improved in vivo retention and decreased plasma drug concentration fluctuation.

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A Prospective, Randomized Study of Quadruple Therapy and High‐Dose Dual Therapy for Treatment of Helicobacter Pylori Resistant to Both Metronidazole and Clarithromycin

Abstract: Both high-dose dual therapy and quadruple therapy are effective in curing H. pylori infection resistant to both metronidazole and clarithromycin in patients who experienced previous treatment failures.

Cited by 106 publications

References 49 publications

ACG Clinical Guideline: Treatment of Helicobacter pylori Infection

ACG Clinical Guideline: Treatment of Helicobacter pylori Infection

“Rescue” regimens after Helicobacter pylori treatment failure

Preparation and in vitro/in vivo evaluation of esomeprazole magnesium-modified release pellets

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