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Low Dose Balsalazide (1.5 G Twice Daily) and Mesalazine

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Low Dose Balsalazide (1.5 G Twice Daily) and Mesalazine Gut 2001;49:783–789 783 Evangelisches Low dose balsalazide (1.5 g twice daily) and Krankenhaus Kalk, Teaching Hospital of the University of mesalazine (0.5 g three times daily) maintained Gut: first published as 10.1136/gut.49.6.783 on 1 December 2001. Downloaded from Cologne, Germany W Kruis remission of ulcerative colitis but high dose I Medizinische Klinik, balsalazide (3.0 g twice daily) was superior in Christian-Albrechts- University Kiel, preventing relapses Germany S Schreiber Gastroenterologische W Kruis, S Schreiber, D Theuer, J-W Brandes, E Schütz, S Howaldt, B Krakamp, Praxis, Heilbronn, J Hämling, H Mönnikes, I Koop, M Stolte, D Pallant, U Ewald Germany D Theuer Medizinische Klinik I, Abstract remission in patients with ulcerative coli- Städtisches Klinikum, Background—Balsalazide is a new tis compared with a low dose (1.5 g twice Braunschweig, Germany 5-aminosalicylic acid (5-ASA) containing daily) or a standard dose of mesalazine J-W Brandes prodrug. Its eYcacy in comparison with (0.5 g three times daily). All three treat- standard mesalazine therapy and the ments were safe and well tolerated. Castra Regina Centre, optimum dose for maintaining remission (Gut 2001;49:783–789) Regensburg, Germany of ulcerative colitis are still unclear. E Schütz Aims—To compare the relapse preventing Keywords: balsalazide; mesalazine; aminosalicylic acid; ulcerative colitis Medizinische eVect and safety profile of two doses of Kernklinik und balsalazide and a standard dose of Poliklinik, University Eudragit coated mesalazine. Hamburg, Germany Methods—A total of 133 patients with Treatment with 5-aminosalicylic acid (5-ASA) S Howaldt ulcerative colitis in remission were re- containing drugs is the gold standard for main- cruited to participate in a double blind, taining remission in patients with ulcerative Medizinische Klinik I, colitis (UC). In order to deliver orally adminis- Städtisches multicentre, randomised trial: 49 patients Krankenhaus received balsalazide 1.5 g twice daily, 40 tered 5-ASA to the inflamed colonic mucosa Merheim, Cologne, received balsalazide 3.0 g twice daily, and where it exerts its topical action, two diVerent Germany 44 received mesalazine 0.5 g three times modes of targeting have been devised: 5-ASA B Krakamp daily. EYcacy assessments were clinical linked to a carrier molecule (“prodrug”) activity index (CAI) and endoscopic score preventing absorption in the small intestine or Abt. für Innere Medizin, Krankenhaus according to Rachmilewitz, and a histo- specially coated 5-ASA (“mesalazine”) form- Tabea, Hamburg, logical score. In addition, laboratory tests ing a delayed release preparation. http://gut.bmj.com/ Germany were performed and urinary excretion of Balsalazide is a novel prodrug where 5-ASA J Hämling 5-ASA and its metabolite N-Ac-5-ASA is azo bound to 4-aminobenzoyl-â-alanine was analysed. The study lasted for 26 (4-ABA). The azo bond is split by colonic bac- Medizinisches weeks. Zentrum für Innere teria to release 5-ASA in the colon to exert its Medizin, University Results—Balsalazide 3.0 g twice daily anti-inflammatory action. A significant diVer- Marburg, Germany resulted in a significantly higher clinical ence between balsalazide and currently used H Mönnikes remission rate (77.5%) than balsalazide prodrugs (for example, sulphasalazine, olsala- on October 1, 2021 by guest. Protected copyright. 1.5 g twice daily (43.8%) and mesalazine zine) is that both the carrier molecule 4-ABA Klinik für Innere 0.5 g three times daily (56.8%) (p=0.006). and the prodrug are pharmacologically inert Medizin IV, The respective times to relapse were 161 Humboldt-University 1 days, 131 days (p=0.003), and 144 days and devoid of systemic eVects. Charité, Berlin, A recent meta-analysis2 comparing the re- Germany (NS). Accordingly, pairwise contrasts of I Koop the final endoscopic score demonstrated a lapse preventing eVects of the prodrug sul- significant diVerence (p=0.005) between phasalazine (SASP) compared with sulpha free Pathologisches the two balsalazide treatment groups 5-ASA preparations demonstrated the thera- Institut, Bayreuth, while diVerences between either of these peutic superiority of SASP. 5-ASA compounds Germany M Stolte two groups and mesalazine were not also included mesalazine and prodrugs. statistically significant. Patients treated Nevertheless, because of their favourable toler- Astra Zeneca R&D, with balsalazide excreted less 5-ASA and ability and safety, there is a clear tendency Lund, Sweden N-Ac-5-ASA than patients receiving me- towards treatment with sulpha free 5-ASA D Pallant salazine but these diVerences were not preparations in chronic UC. A trial comparing statistically significant. Discontinuation Astra Zeneca GmbH, a prodrug (olsalazine) with mesalazine for Wedel, Germany of the trial because of adverse eVects maintenance therapy showed better therapeu- U Ewald occurred in nine patients: three in the bal- tic eVects with the prodrug.3 salazide 1.5 g twice daily group, two in the Correspondence to: balsalazide 3.0 g twice daily group, and Professor W Kruis, four in the mesalazine 0.5 g three times Evangelisches Krankenhaus : 5-ASA, Kalk, Buchforststr. 2, daily group. No clinically important new Abbreviations used in this paper D-51103 Köln (Cologne), drug safety related findings were identi- 5-aminosalicylic acid; UC, ulcerative colitis; 4-ABA, Germany 4-aminobenzoyl-â-alanine; SASP, sulphasalazine; fied in this study. N-Ac-5-ASA, 5-N-acetylaminosalicylic acid; CAI, Accepted for publication Conclusions—High dose balsalazide (3.0 g clinical activity index; SDS-PAGE, sodium dodecyl 12 March 2001 twice daily) was superior in maintaining sulphate-polyacrylamide gel electrophoresis. www.gutjnl.com 784 Kruis, Schreiber, Theuer, et al Comparative trials have established that bal- 5-ASA. The secondary objective was to investi- salazide is as eVective as SASP, and better tol- gate the systemic eVects of balsalazide com- erated in both active and quiescent UC.1 How- pared with mesalazine, especially the influence ever, there are only limited data comparing on renal function. Gut: first published as 10.1136/gut.49.6.783 on 1 December 2001. Downloaded from balsalazide and mesalazine. We present the results of a trial comparing the therapeutic CLINICAL ASSESSMENTS eVects and tolerability of balsalazide with a At entry, the patient’s medical history was standard dose of mesalazine for maintenance recorded and a physical examination was therapy of UC. In addition, we tested if there is performed. A total colonoscopy was performed dose dependency for the eVects of balsalazide. within 10 days prior to intake of the first dose In contrast with the situation in active UC, it is of the investigational medication. Sigmoidos- unclear if an increase in the dose of the respec- copy was performed at the discretion of the tive 5-ASA compound improves maintenance investigator if colonoscopy had been per- of remission in patients with UC.4 formed during the last six months prior to entry into the trial. The patient’s overall evalu- ation of symptoms was assessed according to Materials and methods the clinical activity index (CAI) of Rachmile- PATIENTS witz.5 Clinical remission was defined as a CAI Twenty one centres in Germany enrolled a <6. Endoscopic findings were also classified total of 133 patients (fig 1). The clinical phase according to Rachmilewitz5 and an EI score <4 lasted from February 1994 to September 1997. was considered to indicate remission. Relapse Patients gave written informed consent and was defined as CAI >6 and EI >4. The approval of the ethics committee of the primary variable of the study was “remission of Ärztekammer Nordrhein as well as of the local UC”, defined as clinical as well as endoscopic research ethics committees were obtained. remission at completion of the study. In Inclusion criteria were: UC involving at least addition, biopsies from the rectum and sigmoid the rectum and sigmoid colon; UC in remission colon were taken at entry and at the end of the for less than one year; at least two acute attacks study period and evaluated by a single patholo- of UC in the medical history; remission— gist (MS). Classification of histological activity clinical as well as endoscopic; and age between was performed according to Truelove and 18 and 70 years. Specific exclusion criteria Richards,6 whereas mild and moderate activity were: proctitis without further extent of the were classified separately. The following classes disease; treatment with oral, intravenous, or were used: 1, normal mucosa; 2, UC in remis- rectal steroids within 14 days prior to visit 1; sion; 3, UC with mild activity; 4, UC with use of antibiotics within 14 days prior to visit 1 moderate activity; 5, UC with severe activity; except for short term therapy of a defined and 6, no UC. infection; immunosuppressive therapy within the last three months; regular treatment with LABORATORY ASSESSMENTS http://gut.bmj.com/ non-steroidal anti-inflammatory agents; and Routine haematology, clinical chemistry, and intolerance to 5-ASA. urine analysis were performed throughout the study. At entry and at the end of the study, METHODS additional urine analyses were undertaken. The study was a randomised, multicentre, Twenty four hour urine was collected within double blind, double dummy, three armed, five days prior to administration of the first parallel group comparison of balsalazide 1.5 g dose of the investigational drug. At the end of twice daily, balsalazide 3.0 g twice daily, and the study, urine collection was started within on October 1, 2021 by guest. Protected copyright. mesalazine 0.5 g three times daily for 26 weeks. 10 days prior to intake of the last dose of the No UC medication other than the respective investigational drug. The volume of urine was study preparations was allowed throughout the measured and a portion was labelled and trial. frozen at −20°C. In addition, a portion of Balsalazide was supplied as capsules con- morning urine was labelled and frozen.
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