Alimentary TractProphylaxis of postoperative relapse in Crohn's disease with mesalamine: European cooperative Crohn's disease study VI☆,☆☆,★
Section snippets
Study design
The study was a prospective, randomized, double-blind multicenter study with a parallel group design comparing the efficacy of 4 g mesalamine (Pentasa) daily with placebo in preventing postoperative recurrence after resective surgery for CD. Twenty-nine centers in Austria, Denmark, Germany, Norway, Sweden, and Switzerland participated. Patient recruitment was started on July 23, 1992. The last patient treatment was completed on June 30, 1996. The trial protocol and the 4 subsequent amendments
Study population
A total of 617 patients were screened between July 1992 and April 1995. One hundred fifty-two patients were not enrolled because of violation of inclusion or applicability of exclusion criteria. Furthermore, 141 eligible patients refused to participate in the study. Thus, 324 patients (70% of the eligible population) were randomized, 154 to mesalamine and 170 to placebo.
Six randomized patients (2 mesalamine, 4 placebo) did not start treatment in time because of postoperative complications and,
Discussion
Prevention of recurrence is still one of the major goals in the treatment of patients with CD. Several studies have either included surgical patients or specifically dealt with the prevention of postoperative relapse.6, 11, 12, 13 In a recent meta-analysis, mesalamine has been shown to exhibit a small therapeutic advantage over placebo; however, the number of patients to be treated for the prevention of a single relapse is quite high.7 This unsatisfactory therapeutic scenario of a burning
References (31)
- et al.
National cooperative Crohn's disease study: results of drug treatment
Gastroenterology
(1979) - et al.
European cooperative Crohn's disease study: results of drug treatment
Gastroenterology
(1984) - et al.
Mesalamine in the maintenance treatment of Crohn's disease: a meta-analysis adjusted for confounding variables
Gastroenterology
(1997) - et al.
Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: a multicenter placebo-controlled study
Gastroenterology
(1993) - et al.
A randomized, placebo-controlled, double-blind trial of mesalamine in the maintenance of remission of Crohn's disease
Gastroenterology
(1997) - et al.
Prophylactic mesalamine treatment decreases postoperative recurrence of Crohn's disease
Gastroenterology
(1995) - et al.
Rederived values of the eight coefficients of the Crohn's disease activity index (CDAI)
Gastroenterology
(1979) - et al.
Mesalamine in the prevention of endoscopic recurrence after intestinal resection for Crohn's disease
Gastroenterology
(1995) - et al.
Delivery and fate of oral mesalamine microgranules within the human small intestine
Gastroenterology
(1995) - et al.
Oral contraceptive use and smoking are risk factors for relapse in Crohn's disease
Gastroenterology
(1998)
Cigarette smoking and inflammatory bowel disease
Gastroenterology
Post-operative treatment with corticosteroids and salazosulphapyridine (Salozopyrin) after resection for Crohn's disease
Scand J Gastroenterol
Controlled trial of metronidazole treatment for prevention of Crohn's recurrence after ileal resection
Gastroenterology
Long-term experience with 6-mercaptopurine in the treatment of Crohn's disease
Am J Gastroenterol
Post-operative with 6-MP, 5-ASA or placebo in Crohn's disease. A 2 year multicenter trial (abstr)
Gastroenterology
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Supported by a grant from Ferring AS, Denmark, and Ferring Arzneimittel, Germany.
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Address requests for reprints to: Herbert Lochs, M.D., Universitaetsklinikum Charité, Medizinische Klinik, Schumannstrasse 20/21, D-10117 Berlin, Germany. e-mail: [email protected]; fax: (49) 2802-8978.
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The investigators and centers that participated in this study are as follows: Austria: D. Genser, Abteilung für Gastroenterologie und Hepatologie, Universitätsklinik für Innere Medizin, Vienna; W. Petritsch and T. Hinterleitner, Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universitätsklinik Graz, Graz. Germany: M. Raithel, Medizinische Klinik I der Universität Erlangen, Erlangen; R. Hoffmann, Abteilung für Gastroenterologie, Städtische Krankenanstalten, Esslingen; J. Holtz and K. Plein, Klinik für Gastroenterologie, Allgemeines Krankenhaus Celle, Celle; P. Otto and A. Thilo, Abteilung für Innere Medizin, Kreiskrankenhaus Groβburgwedel, Burgwedel; A. Raedler, Medizinische Klinik, Universitätskrankenhaus Eppendorf, Hamburg; H. Jenss and B. Kaskas, Abteilung Innere Medizin I, Medizinische Universitätsklinik, Tübingen; I. Koop and M. Frank, Abteilung Gastroenterologie, Klinikum Lahnberge, Marburg; K. Loeschke, Medizinische Klinik Innenstadt der LMU, München; W. Dotzel, Abteilung Gastroenterologie, Städtische Kliniken, Darmstadt; C. Scheurlen, I. Medizinische Klinik der Universität Bonn, Bonn; V. Gross and I. Caesar, Medizinische Klinik I, Klinikum der Universität, Regensburg; A. Reissmann, Klinik und Poliklinik für Innere Medizin I, Martin-Luther-Universität, Halle; B. A. Volk, Medizinische Klinik der Universität, Freiburg; J. Körber, Medizinische Klinik, Charité Campus Virchow-Klinikum, Berlin; H. Lorenz-Meyer, Medizinische Klinik, Städtisches Krankenhaus, Friedrichshafen; B. May and A. Tromm, Klinik Bergmannsheil, Bochum; E. Stange and S. Schwarting, Medizinische Klinik, Universität Lübeck, Lübeck; J. Emmrich and A. Schwager, Klinik für Innere Medizin, Universität Rostock, Rostock; H. Bossekert, Klinik für Innere Medizin I, Universität Jena, Jena. Denmark: P. Broebech Mortensen and Michael Staun, Med. Gastroenterol. afd. A 2101, Rigshospitalet, Copenhagen; S. N. Rasmussen and Jan Fallingborg, Med. Gastroenterol. Afd. M, Ålborg Sygehus Syd, Ålborg; Lone Astrup and F. Bendtsen, Med. afd V, Århus Universitetshospital, Kommunehospitalet, Århus; Ellinor Hylander Møller, Roskilde Amts Sygehus Køge, Med. Dept. C-3, Køge; Ole Østergaard Thomsen and O. H. Nielsen, Med. Gastroenterol. Afd. C, Amtssygehuset i Herlev, Herlev. Sweden: M. Bohe and C. Benoni, Kirurgkliniken, Malmö Allmänna Sjukhus, Malmö. Norway: Lars Birger Nesje and A. Berstad, Division of Gastroenterology, Department of Medicine/Surgery, Haukeland University Hospital, Bergen. Switzerland: M. Cunningham, Departement de Gastroenterologie, Hôpital Cantonal Universitaire de Genève, Geneva; P. Netzer, J. Binek, and B. Hammer, Abteilung Gastroenterologie, Kantonsspital, St. Gallen. Industrial Cooperation: R. Gödde, Ferring Arzneimittel GmbH, Kiel, Germany; Ch. Guldberg, Ferring AS, Kopenhagen, Denmark.