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Official websites use. Share sensitive information only on official, secure websites. Helicobacter pylori H. In the present study we analyzed the data for H. Slovenia is a part of the European Registry on Helicobacter pylori Management from the beginning. In seven medical institutions data for H. For further modified intention to treat mITT analysis patients were eligible and for per protocol PP analysis patients. Ten to fourteen day Bismuth quadruple therapy was the therapy in difficult to treat patients. At the end all patients that adhered to prescribed regimens were cured of their H. High dropout rate deserves further analysis. Key words: Helicobacter pylori , eradication treatment, European Registry on Helicobacter pylori management, Slovenian results. Several national guidelines have recommended eradication in all H. The basis of modern H. The treatment success depends on H. Thirty one countries and recruiting investigators are included in the Hp-EuReg. So far, more than The Scientific Committee of the project is comprised by Javier P. McNicholl Scientific Coordinator. A list of 30 European Countries has been selected. In each country a National Coordinator was elected based on its clinical and research activity. Slovenian National Coordinator is Bojan Tepes. The National Coordinators constitutes the monitoring and drafting committee of the registry in a certain country. The Recruiting Investigators are gastroenterologists attending an adult population with a gastroenterology outpatient clinic that assists H. Eradication confirmation tests have to be performed routinely. Patients are managed and registered following routine clinical practice. REDCap Research Electronic Data Capture is a secure, web-based application designed to support data capture for research studies, providing 1 an intuitive interface for validated data entry; 2 audit trails for tracking data manipulation and export procedures; 3 automated export procedures for seamless data downloads to common statistical packages; and 4 procedures for importing data from external sources. The e-CRF includes variables including demographics, history and comorbidity, data on infection and diagnosis, previous eradication attempts, current treatment, compliance, adverse events and efficacy. All patient data was anonymized. Main outcome is confirmed eradication at least 4 weeks after treatment. As the registry is ongoing, a pure Intention to treat ITT analysis cannot be provided. This mITT includes for analyses all patients whose outcome has been registered by their doctors eradication success, failure or lost to follow up , plus those that although their result has not been registered were treated more than a year prior to analysis. Patients classified as failure, lost or without registered outcome will be considered treatment failure in the mITT analysis. Continuous variables are presented as the arithmetic mean and SDs. One- and two-sided tests were used for the analyses and the P-value cut off for significance was set to less than 0. Data was collected in seven medical institutions in Slovenia from April 16 th to May 15 th for patients Table 1. Two hundred and fifty-five All the remaining patients were eligible for further analysis in the modified intention to treat mITT group; Out of those, patients had their outcome registered and were eligible for analysis in the per protocol PP group. There were patients We consider that group a drop out patients group. We do not know if these patients took their therapy or whether they had the UBT done in the primary medical care and because of that did not return to their gastroenterologist, which can be a realistic option. Only in 56 patients who took part in a RCT, primary H. The highest resistance rate was for metronidazole M; All the other antimicrobial susceptibility tests have been performed in treatment failure patients. The percentage of resistance to different antibiotics rose with the number of treatment attempts. Ten different 7—14 days triple combinations were used in patients as a first line treatment. The majority of patients 1. No significant differences were found regarding the type of PPI used. Six different triple 7—14 days treatments were used in patients whose H. This treatment is according to our guidelines the recommended one for second line. Dropout rate for the second treatment attempt was 6. Bismuth is not available in Slovenia and those that need third or fourth line treatment regimen should buy it in Germany or in any other country in Europe where it is available. At the moment this treatment is not reimbursed Tables 6,7. Dropout rate after third line therapy was Seven patients were treated with fourth line treatment regimen Table 7 , one was treated with fifth, and one with sixth line treatment. No drop out has been recorded in the group with four or more treatment attempts. At the end all patients that start their treatment and comply with the treatment regimens were cured of their H. High dropout rate - All 66 patients 3. They were most probably controlled by their general practitioner, but we are not aware of their UBT results. And many more dropout patients from other medical centers could be treated in the same way. It was That can explain the still relatively good eradication results for 7 day triple therapy TT. In some other parts of the world due to the increasing incidence of H. Maastricht IV suggest not to use 7 day triple therapy in countries with H. Our H. Ten different days triple combinations were used as a first line therapy. In our last H. This shows us that real clinical practice in Slovenia is not ideal, which was also recognized in some other countries shown in Hp-EuReg data. We did not show any benefits of esomeprazole over other PPIs in the eradication rates as was shown in some other studies. When H. In the National recommendation 7 only 14 day therapy should be used as a second line treatment. But in real practice, gastroenterologists use therapies from days. This variations need to be corrected, because longer duration of second line therapies mean also better cure rates. We know that this is due to low H. Other possible second line treatment could also be sequential or non-bismuth concomitant therapy with PPI and all three antibiotics C, M, E. These therapies can be effective also in the regions with H. In the third and fourth line treatment PPI A L was used in some patients not treated with this regimen before, as well as bismuth quadruple therapies. Some patients were treated with 14 day therapies, but not all, which should also be corrected. In Maastricht recommendations culture and antibiotic susceptibility should be done after two unsuccessful therapeutic attempts 2 , but we seldom use this approach. The reason for this is non-reimbursement for culture by our National health fund. One patient has been treated for the fifth time and one for the sixth time, both successfully. So finally all patients who were compliant with the prescribed therapeutic regimens were eradicated of H. Hp-EuReg is a very important clinical registry which helps us audit real clinical practice in the field of H. From the analysis of our Slovenian data we can figure out some clinically important conclusions:. Treatment duration should be prolonged to 14 days. Dropout rate is too high. We must provide all general practitioners with the possibility to use urea breath test or monoclonal stool antibody test in all patients with H. No patients should be without confirmation of eradication success. Treatment failures of the first line regimen should be retreated according to National guidelines, that is with 14 day PPI A L regimen. Primary H. We want to thank the data monitors of the study, Mercedes Ramas, Lorena Lee and Irene Barbado for their large efforts to ensure the validity of the data and quality of their work. McNicholl for providing the e-CRF service free of charge. As a library, NLM provides access to scientific literature. Radiol Oncol. Find articles by Bojan Tepes. Find articles by Marko Kastelic. Find articles by Miroslav Vujasinovic. Find articles by Polona Lampic. Find articles by Maja Seruga. Find articles by Natasa Brglez Jurecic. Find articles by Olga P Nyssen. Find articles by Maria G Donday. Find articles by Francis Megraud. Find articles by Adrian G McNicholl. Find articles by Javier P Gisbert. Nyssen, Maria G. Open in a new tab. Deviation Female Fourth treatment Fifth treatment No resistance First line treatment results for treatment regimens with more than 15 patients. Clarythromycin, amoxicillin, PPI, 7 days Second line treatment results for treatment regimens with more than 15 patients. Amoxicillin, Levofloxacin, PPI, 14 days 70 Disclosure: No potential conflicts of interest were disclosed. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel.

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