Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial
ObjectiveThe aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence.MethodsThis was a 1 year, double-blind, double-dummy, randomised study...
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Published in | Gut Vol. 59; no. 6; pp. 752 - 759 |
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Main Authors | , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
London
BMJ Publishing Group Ltd and British Society of Gastroenterology
01.06.2010
BMJ Publishing Group BMJ Publishing Group LTD |
Subjects | |
Online Access | Get full text |
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Abstract | ObjectiveThe aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence.MethodsThis was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6–24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score <200, but with moderate or severe endoscopic recurrence. The study drugs were azathioprine 2.0–2.5 mg/kg/day or mesalazine 4 g/day over 1 year. The primary end point was therapeutic failure during 1 year, defined as a CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.ResultsTreatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI −5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing ≥1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023).ConclusionsIn this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure.Clinical trial registration numberNCT00946946. |
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AbstractList | Objective The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence. Methods This was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6–24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score <200, but with moderate or severe endoscopic recurrence. The study drugs were azathioprine 2.0–2.5 mg/kg/day or mesalazine 4 g/day over 1 year. The primary end point was therapeutic failure during 1 year, defined as a CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. Results Treatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI −5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing ≥1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023). Conclusions In this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure. Clinical trial registration number NCT00946946. ObjectiveThe aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence.MethodsThis was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6–24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score <200, but with moderate or severe endoscopic recurrence. The study drugs were azathioprine 2.0–2.5 mg/kg/day or mesalazine 4 g/day over 1 year. The primary end point was therapeutic failure during 1 year, defined as a CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.ResultsTreatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI −5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing ≥1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023).ConclusionsIn this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure.Clinical trial registration numberNCT00946946. OBJECTIVEThe aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence.METHODSThis was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6-24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score <200, but with moderate or severe endoscopic recurrence. The study drugs were azathioprine 2.0-2.5 mg/kg/day or mesalazine 4 g/day over 1 year. The primary end point was therapeutic failure during 1 year, defined as a CDAI score > or = 200 and an increase of > or = 60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.RESULTSTreatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI -5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing > or = 1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023).CONCLUSIONSIn this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure. Objective The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence. Methods This was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6-24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score <200, but with moderate or severe endoscopic recurrence. The study drugs were azathioprine 2.0-2.5 mg/kg/day or mesalazine 4 g/day over 1 year. The primary end point was therapeutic failure during 1 year, defined as a CDAI score â[per thousand]¥200 and an increase of â[per thousand]¥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. Results Treatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI -5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing â[per thousand]¥1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023). Conclusions In this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure. Clinical trial registration number NCT00946946. The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's disease (CD) with moderate or severe endoscopic recurrence. This was a 1 year, double-blind, double-dummy, randomised study which took place in 21 gastroenterology centres in Austria, the Czech Republic, Germany and Israel. The study participants were 78 adults with CD who had undergone resection with ileocolonic anastomosis in the preceding 6-24 months without subsequent clinical recurrence and with a Crohn's disease activity index (CDAI) score <200, but with moderate or severe endoscopic recurrence. The study drugs were azathioprine 2.0-2.5 mg/kg/day or mesalazine 4 g/day over 1 year. The primary end point was therapeutic failure during 1 year, defined as a CDAI score > or = 200 and an increase of > or = 60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. Treatment failure occurred in 22.0% (9/41) of azathioprine-treated patients and 10.8% (4/37) of mesalazine-treated patients, a difference of 11.1% (95% CI -5.0% to 27.3%, p=0.19). Clinical recurrence was significantly less frequent with azathioprine versus mesalazine (0/41 (0%) vs 4/37 (10.8%), p=0.031), whereas study drug discontinuation due to adverse drug reactions only occurred in azathioprine-treated patients (9/41 (22.0%) vs 0%, p=0.002). The proportion of patients showing > or = 1 point reduction in Rutgeerts score between baseline and month 12 was 63.3% (19/30) and 34.4% (11/32) in the azathioprine and mesalazine groups, respectively (p=0.023). In this population of patients with postoperative CD at high risk of clinical recurrence, superiority for azathioprine versus mesalazine could not be demonstrated for therapeutic failure. |
Author | Stange, Eduard F Angelberger, Sieglinde Schaeffeler, Elke Greinwald, Roland Reinisch, Walter Lukas, Milan Dilger, Karin Schwab, Matthias Herrlinger, Klaus R Petritsch, Wolfgang Shonova, Olga Teml, Alexander Mueller, Ralph Bar-Meir, Simon |
Author_xml | – sequence: 1 givenname: Walter surname: Reinisch fullname: Reinisch, Walter email: walter.reinisch@meduniwien.ac.at organization: Abteilung Gastroenterologie and Hepatologie, Universitätsklinik für Innere Medizin III, Vienna, Austria – sequence: 2 givenname: Sieglinde surname: Angelberger fullname: Angelberger, Sieglinde email: walter.reinisch@meduniwien.ac.at organization: Abteilung Gastroenterologie and Hepatologie, Universitätsklinik für Innere Medizin III, Vienna, Austria – sequence: 3 givenname: Wolfgang surname: Petritsch fullname: Petritsch, Wolfgang email: walter.reinisch@meduniwien.ac.at organization: Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria – sequence: 4 givenname: Olga surname: Shonova fullname: Shonova, Olga email: walter.reinisch@meduniwien.ac.at organization: Nemocnice Ceske Budejovice, Gastroenterologicke oddeleni, Ceske Budejovice, Czech Republic – sequence: 5 givenname: Milan surname: Lukas fullname: Lukas, Milan email: walter.reinisch@meduniwien.ac.at organization: Klinické centrum, Iscare Lighthouse, Prague, Czech Republic – sequence: 6 givenname: Simon surname: Bar-Meir fullname: Bar-Meir, Simon email: walter.reinisch@meduniwien.ac.at organization: Department of Gastroenterology, Chaim Sheba Medical Centre Tel Hashomer, Tel Hashomer, Israel – sequence: 7 givenname: Alexander surname: Teml fullname: Teml, Alexander email: walter.reinisch@meduniwien.ac.at organization: Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, University of Tübingen, Stuttgart, Germany – sequence: 8 givenname: Elke surname: Schaeffeler fullname: Schaeffeler, Elke email: walter.reinisch@meduniwien.ac.at organization: Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, University of Tübingen, Stuttgart, Germany – sequence: 9 givenname: Matthias surname: Schwab fullname: Schwab, Matthias email: walter.reinisch@meduniwien.ac.at organization: Department Clinical Pharmacology, University Hospital Tübingen, Germany – sequence: 10 givenname: Karin surname: Dilger fullname: Dilger, Karin email: walter.reinisch@meduniwien.ac.at organization: Dr Falk Pharma GmbH, Freiburg, Germany – sequence: 11 givenname: Roland surname: Greinwald fullname: Greinwald, Roland email: walter.reinisch@meduniwien.ac.at organization: Dr Falk Pharma GmbH, Freiburg, Germany – sequence: 12 givenname: Ralph surname: Mueller fullname: Mueller, Ralph email: walter.reinisch@meduniwien.ac.at organization: Dr Falk Pharma GmbH, Freiburg, Germany – sequence: 13 givenname: Eduard F surname: Stange fullname: Stange, Eduard F email: walter.reinisch@meduniwien.ac.at organization: Robert-Bosch Krankenhaus, Innere Medizin I, Stuttgart, Germany – sequence: 14 givenname: Klaus R surname: Herrlinger fullname: Herrlinger, Klaus R email: walter.reinisch@meduniwien.ac.at organization: Robert-Bosch Krankenhaus, Innere Medizin I, Stuttgart, Germany |
BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22789505$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20551460$$D View this record in MEDLINE/PubMed |
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ContentType | Journal Article |
Contributor | Fich, Alexander Barth, Christoph Pagel, Albert Fellermann, Klaus Metter, Klaus Dosedel, Josef Reinisch, Walter Andus, Tilo Douda, Tomas Konikoff, Fred Harrer, Marie-Luise Serclova, Zuzana Gregar, Jan Angelberger, Sieglinde Sillinger, Pavel Prokopová, Lucie Jahnel, Jörg Herrlinger, Klaus Bok, Robert Doppelmayr, Hildegard Rauchwerger, Ariela Prinz, Georgiana Novakova, Marie Zbori, Vladimir Mudr, Robert Benes, Zdenek Hajek, Josef Fabian, Jiri Bar-Meir, Simon Rosner, Guy Ulitsky, Julia Kirchgatterer, Andreas Becker, Stuart A Haas, Thomas Israeli, Eran Brunner, Harald Tillinger, Wolfgang Naftali, Timna Datz, Christian Konecny, Michal Antos, F Petritsch, Wolfgang Bures, Jan Teml, Alexander Mittischek, Karin Shonova, Olga Stange, Eduard F Schweiger, Karin Fröhlich, Bernhard Dotan, Iris Lukas, Milan Odes, Shmuel Vavra, Jiri Goldin, Eran Knoflach, Peter Kohout, Pavel Bortlik, Martin Schnabel, Daniel Wenzl, Heimo |
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Copyright | 2010, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. 2015 INIST-CNRS Copyright: 2010 (c) 2010, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. |
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Keywords | Human Postoperative Prostaglandin-endoperoxide synthase Relapse Enzyme Toxicity Thiopurine derivatives Enzyme inhibitor Inflammatory disease Non steroidal antiinflammatory agent Prevention Crohn disease Analgesic Mesalazine Gastroenterology Antipyretic Digestive diseases Intestinal disease Oxidoreductases Salicylates Endoscopy Immunosuppressive agent Azathioprine Comparative study |
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Snippet | ObjectiveThe aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative... Objective The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative... The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative Crohn's... OBJECTIVEThe aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with postoperative... |
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SubjectTerms | Adult Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Azathioprine Azathioprine - adverse effects Azathioprine - therapeutic use Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents Clinical medicine Colonoscopy Crohn Disease - prevention & control Crohn Disease - surgery Crohn's disease Crohns disease Disease prevention Double-Blind Method Drug dosages Endoscopy Female Gastroenterology. Liver. Pancreas. Abdomen Humans Immunosuppressive Agents - therapeutic use Male Medical sciences mesalamine Mesalamine - adverse effects Mesalamine - therapeutic use mesalazine Methyltransferases - blood Middle Aged Other diseases. Semiology Patient Selection Pharmacology. Drug treatments Secondary Prevention Severity of Illness Index Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Surgery TPMT Treatment Outcome Young Adult |
Title | Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial |
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