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P C Thornton - One of the best experts on this subject based on the ideXlab platform.

  • short report comparison of two doses of Balsalazide in maintaining ulcerative colitis in remission over 12 months
    2007
    Co-Authors: Jonathan R B Green, J A Gibson, G D Kerr, C H J Swan, A Rowlinson, P Brown, E T Swarbrick, P C Thornton
    Abstract:

    In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive Balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of Balsalazide.

  • Balsalazide in the maintenance treatment of patients with ulcerative colitis a double blind comparison with sulphasalazine
    2007
    Co-Authors: Peter Mcintyre, J E Lennardjones, C A Rodrigues, J H Baron, I G Barrison, J G Walker, P C Thornton
    Abstract:

    Balsalazide (BSZ) is a pro-drug which releases 5-aminosalicylic acid (5ASA) and 4-aminobenzoyl-beta-alanine (an inert carrier) in the colon of various species including man. BSZ was compared with sulphasalazine (SASP) (both 1 g b.d. orally) in the maintenance of remission in patients with ulcerative colitis (UC). Seventy-nine patients (53 male, 26 female), mean age 49 years (range 19-79 years), with UC were randomly allocated to either treatment (41 BSZ, 38 SASP) for 6 months. The groups were similar in respect of age, sex, duration and extent of disease. Seven patients defaulted (3 BSZ, 4 SASP) leaving 38 on BSZ and 34 on SASP. Two male patients, both receiving SASP, were withdrawn because of severe side-effects. One of these patients, with an exfoliative rash, was maintained satisfactorily on open BSZ. Remission rates at 6 months (51% BSZ, 63% SASP) were not significantly different (life-table analysis P less than 0.1). Twelve patients (15%) reported troublesome side-effects (2 BSZ 5%, 10 SASP 26%, P = 0.017 Fisher Exact Test). Mean haemoglobin concentrations, similar on entry, increased after 6 months with BSZ (0.2 g/dl) but decreased with SASP (0.5 g/dl) (P less than 0.0002). BSZ was not significantly different from SASP in maintaining remission in patients with UC but had fewer side-effects.

  • patient led variable dosing with Balsalazide as long term therapy for maintenance in ulcerative colitis a 3 year prospective observational study
    2004
    Co-Authors: Jonathan R B Green, J A Gibson, G D Kerr, C H J Swan, E T Swarbrick, P C Thornton
    Abstract:

    Summary Background : The patient-centred approach is new to the management of ulcerative colitis. To date, it has only been shown to be successful in a short-term study. Aim : To assess the feasibility, safety and efficacy of patient-led dosing using Balsalazide in the long-term treatment of ulcerative colitis. Methods : This was a 3-year, two-cohort, multi-centre study: one cohort was in stable remission (52 patients) and the other was newly in remission (76 patients) from ulcerative colitis. Two 750-mg Balsalazide capsules were given twice daily for maintenance, increased by 750-mg increments to a maximum of 6 g for up to 7 days depending on symptom severity. Clinical assessments were made every 12–14 weeks; laboratory assessments were made every 6 months. Results : The average median daily dose of Balsalazide was 3 g (range, 1.5–6 g). In the cohort with stable remission, 23 patients (44%) had relapsed by 3 years [median time to relapse, > 1095 days (36 months)]. In the cohort newly in remission, these values were 45 patients (59%) and 656 days (22 months), respectively. In the cohort with stable remission, the time since last relapse was significantly associated with relapse during the first year of treatment (P < 0.033). Conclusions : Long-term, patient-led, maintenance treatment with Balsalazide is well tolerated with a good safety profile and is effective for patients with ulcerative colitis.

  • a double blind comparison of Balsalazide 6 75 g daily and sulfasalazine 3 g daily in patients with newly diagnosed or relapsed active ulcerative colitis
    2002
    Co-Authors: J R B Green, John C Mansfield, J A Gibson, G D Kerr, P C Thornton
    Abstract:

    Background: Sulfasalazine is well established in the treatment of active ulcerative colitis. Intolerance to sulfasalazine, however, is a common problem. Balsalazide has been designed to deliver 5-aminosalicylic acid to the colon without the poor tolerability of sulfasalazine. Aim: To compare the safety and efficacy of Balsalazide, 6.75 g daily, with sulfasalazine, 3 g daily, in the treatment of active ulcerative colitis of all grades of severity. Methods: Balsalazide and sulfasalazine were compared in a multicentre, double-blind, parallel group study over 12 weeks. Patients were stratified for disease severity and topical and/or oral steroids were co-administered where clinically necessary. Results: Fifty-seven patients were randomized: 28 to receive Balsalazide and 29 to receive sulfasalazine. Significantly fewer patients withdrew from the Balsalazide group due to adverse events (2/28 vs. 9/29, P=0.041). These data confirm that Balsalazide is better tolerated than sulfasalazine. In patients able to tolerate the treatment, similar improvements were recorded in clinical, sigmoidoscopic and histological assessments in both treatment groups. Conclusions: This study confirms the better tolerability of Balsalazide compared to sulfasalazine, and supports the use of Balsalazide in ulcerative colitis of all grades of severity.

  • a double blind comparison of Balsalazide 6 75 g and sulfasalazine 3 g as sole therapy in the management of ulcerative colitis
    2002
    Co-Authors: John C Mansfield, P C Thornton, M H Giaffer, P A Cann, D Mckenna, C D Holdsworth
    Abstract:

    Background: Sulfasalazine is accepted therapy for active ulcerative colitis, but side-effects and intolerance are common. Balsalazide is an azo-bonded pro-drug which also releases 5-aminosalicylic acid into the colon, but uses an inert carrier molecule. Aim: To compare the safety and efficacy of sul- fasalazine, 3 g, with Balsalazide, 6.75 g, in the initial daily treatment of mild to moderate ulcerative colitis. Methods: A randomized, multicentre, double-blind, parallel group study was performed, with a treatment duration of 8 weeks. Patients on previous maintenance treatment were excluded. The trial medication was the sole treatment for the colitis. Efficacy was assessed by patient diaries, symptom assessment, sigmoidoscopic appearance and histology. Results: Fifty patients were recruited: 26 allocated to the Balsalazide group and 24 to the sulfasalazine group. More patients withdrew due to adverse events in the sulfasalazine group (nine patients vs. one patient in the Balsalazide group, P=0.004). Improvement occurred in both groups, with a tendency to a faster response with Balsalazide. Of the patients taking Balsalazide, 61% achieved clinical and sigmoidoscopic remission. Conclusions: Balsalazide, 6.75 g, is effective as the sole treatment for patients with mild to moderately active ulcerative colitis, with significantly fewer withdrawals due to side-effects than in a similar group of patients taking sulfasalazine, 3 g.

G D Kerr - One of the best experts on this subject based on the ideXlab platform.

  • short report comparison of two doses of Balsalazide in maintaining ulcerative colitis in remission over 12 months
    2007
    Co-Authors: Jonathan R B Green, J A Gibson, G D Kerr, C H J Swan, A Rowlinson, P Brown, E T Swarbrick, P C Thornton
    Abstract:

    In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive Balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of Balsalazide.

  • patient led variable dosing with Balsalazide as long term therapy for maintenance in ulcerative colitis a 3 year prospective observational study
    2004
    Co-Authors: Jonathan R B Green, J A Gibson, G D Kerr, C H J Swan, E T Swarbrick, P C Thornton
    Abstract:

    Summary Background : The patient-centred approach is new to the management of ulcerative colitis. To date, it has only been shown to be successful in a short-term study. Aim : To assess the feasibility, safety and efficacy of patient-led dosing using Balsalazide in the long-term treatment of ulcerative colitis. Methods : This was a 3-year, two-cohort, multi-centre study: one cohort was in stable remission (52 patients) and the other was newly in remission (76 patients) from ulcerative colitis. Two 750-mg Balsalazide capsules were given twice daily for maintenance, increased by 750-mg increments to a maximum of 6 g for up to 7 days depending on symptom severity. Clinical assessments were made every 12–14 weeks; laboratory assessments were made every 6 months. Results : The average median daily dose of Balsalazide was 3 g (range, 1.5–6 g). In the cohort with stable remission, 23 patients (44%) had relapsed by 3 years [median time to relapse, > 1095 days (36 months)]. In the cohort newly in remission, these values were 45 patients (59%) and 656 days (22 months), respectively. In the cohort with stable remission, the time since last relapse was significantly associated with relapse during the first year of treatment (P < 0.033). Conclusions : Long-term, patient-led, maintenance treatment with Balsalazide is well tolerated with a good safety profile and is effective for patients with ulcerative colitis.

  • a double blind comparison of Balsalazide 6 75 g daily and sulfasalazine 3 g daily in patients with newly diagnosed or relapsed active ulcerative colitis
    2002
    Co-Authors: J R B Green, John C Mansfield, J A Gibson, G D Kerr, P C Thornton
    Abstract:

    Background: Sulfasalazine is well established in the treatment of active ulcerative colitis. Intolerance to sulfasalazine, however, is a common problem. Balsalazide has been designed to deliver 5-aminosalicylic acid to the colon without the poor tolerability of sulfasalazine. Aim: To compare the safety and efficacy of Balsalazide, 6.75 g daily, with sulfasalazine, 3 g daily, in the treatment of active ulcerative colitis of all grades of severity. Methods: Balsalazide and sulfasalazine were compared in a multicentre, double-blind, parallel group study over 12 weeks. Patients were stratified for disease severity and topical and/or oral steroids were co-administered where clinically necessary. Results: Fifty-seven patients were randomized: 28 to receive Balsalazide and 29 to receive sulfasalazine. Significantly fewer patients withdrew from the Balsalazide group due to adverse events (2/28 vs. 9/29, P=0.041). These data confirm that Balsalazide is better tolerated than sulfasalazine. In patients able to tolerate the treatment, similar improvements were recorded in clinical, sigmoidoscopic and histological assessments in both treatment groups. Conclusions: This study confirms the better tolerability of Balsalazide compared to sulfasalazine, and supports the use of Balsalazide in ulcerative colitis of all grades of severity.

  • Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis
    1998
    Co-Authors: Jonathan R B Green, G D Kerr, A J Lobo, Charles D Holdsworth, Roger J Leicester, John Gibson, Humphrey Hodgson, Katharine J Parkins, M D Taylor
    Abstract:

    Abstract Background & Aims: Aminosalicylates are widely used in the treatment of ulcerative colitis (UC). Balsalazide is a novel mesalamine prodrug, activated by colonic bacteria. The aim of this study was to compare the efficacy and safety of Balsalazide with that of a pH-dependent formulation of mesalamine in active UC. Methods: A randomized, double-blind study was performed comparing Balsalazide, 6.75 g daily, with mesalamine, 2.4 g daily, administered for 4, 8, or 12 weeks to 101 (99 evaluable) patients with symptomatic, sigmoidoscopically verified UC. Results: More patients treated with Balsalazide achieved symptomatic remission after 2 (64% [Balsalazide] vs. 43% [mesalamine]), 4 (70% vs. 51%), 8 (78% vs. 45%), and 12 weeks (88% vs. 57%) and complete remission (none/mild symptoms, sigmoidoscopy grade 0/1, no rectal steroid use within 4 days) after 4 (38% vs. 12%), 8 (54% vs. 22%), and 12 weeks (62% vs. 37%). Patients taking Balsalazide experienced more asymptomatic days (4 weeks, 24% vs. 14%) and achieved the first asymptomatic day more rapidly (median, 10 vs. 25 days). Fewer patients in the Balsalazide group reported adverse events (48% vs. 71%); four serious adverse events occurred in the mesalamine group. Conclusions: Balsalazide is more effective and better tolerated than mesalamine as treatment for acute UC. GASTROENTEROLOGY 1998;114:15-22

Lorin K Johnson - One of the best experts on this subject based on the ideXlab platform.

Mohammad Abdollahi - One of the best experts on this subject based on the ideXlab platform.

  • A Meta-Analysis of the Efficacy of Sulfasalazine in Comparison with 5-Aminosalicylates in the Induction of Improvement and Maintenance of Remission in Patients with Ulcerative Colitis
    2009
    Co-Authors: Shekoufeh Nikfar, Roja Rahimi, Ali Rezaie, Mohammad Abdollahi
    Abstract:

    Background Historically, sulfasalazine (SSZ) and 5-aminosalicylates (5-ASAs) have been a mainstay of mild-to-moderate ulcerative colitis (UC) remission induction and maintenance therapy. Considering the pivotal role of intestinal microbial flora in pathophysiology of UC and antimicrobial activity of sulfapyridine, we hypothesized that SSZ might be more effective than 5-ASAs in the management of UC. Aim To compare the efficacy and tolerability of SSZ with each of the 5-ASAs (mesalamine, olsalazine, and Balsalazide) by a meta-analysis technique. Methods Pubmed, Embase, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were searched for studies compared efficacy and/or tolerability of SSZ with 5-ASAs in the management of UC. The search terms were: “sulfasalazine” or “sulfasalazine” and “5-aminosalicylic acid,” “mesalazine,” “mesalamine,” “olsalazine” or “Balsalazide” and “ulcerative colitis.” Data were collected from 1966 to April 2008. There was no language restriction. “Overall improvement,” “relapse rate,” “total adverse events,” and “withdrawals because of adverse events” were the key outcomes of interest. Results Twenty randomized placebo controlled trials met our criteria and were included in the meta-analysis. Comparison of SSZ with mesalamine yielded a nonsignificant relative risk (RR) of 1.04 (95% confidence interval of 0.89–1.21, P  = 0.63) for overall improvement, a nonsignificant RR of 0.98 (95% CI 0.78–1.23, P  = 0.85) for relapse, a nonsignificant RR of 0.76 (95% CI 0.54–1.07, P  = 0.11) for any adverse events, and a nonsignificant RR of 0.78 (95% CI 0.46–1.3, P  = 0.33) for withdrawals due to adverse events. Comparison of SSZ with olsalazine yielded a nonsignificant RR of 1.14 (95% CI 0.91–1.43, P  = 0.25) for overall improvement, a nonsignificant RR of 0.93 (95% CI 0.77–1.12, P  = 0.42) for relapse, a nonsignificant RR of 1.21 (95% CI 0.9–1.61, P  = 0.20) for any adverse events, and a nonsignificant RR of 1.53 (95% CI 0.93–2.52, P  = 0.09) for withdrawals due to adverse events. Comparison of SSZ with Balsalazide yielded a nonsignificant RR of 1.3 (95% CI 0.93–1.81, P  = 0.12) for overall improvement, and a significant RR of 0.17 (95% CI 0.06–0.49, P  = 0.001) for withdrawals because of adverse events. Conclusion SSZ does not differ from mesalamine or olsalazine in terms of efficacy and tolerability in UC. Withdrawal from study due to adverse events was significantly lower for Balsalazide compared with SSZ. Convincing conclusions on the comparison of effectiveness and safety of Balsalazide and SSZ in UC remains to be elucidated by further clinical trials. Considering the lower cost of treatment with SSZ and the equal rate of adverse events with other 5-ASAa, it is not surprising to suggest SSZ as a first-choice treatment for UC and reserve 5-ASAs for when SSZ intolerability occurs.

  • Comparison of Mesalazine and Balsalazide in Induction and Maintenance of Remission in Patients with Ulcerative Colitis: A Meta-Analysis
    2009
    Co-Authors: Roja Rahimi, Shekoufeh Nikfar, Ali Rezaie, Mohammad Abdollahi
    Abstract:

    Background 5-Aminosalicylates are the standard treatment for induction and maintenance of remission in mild-to-moderate ulcerative colitis. In recent years, the 5-aminosalicylic acid-containing pro-drug Balsalazide has been the focus of attention. Aim To compare the efficacy and tolerance of Balsalazide and mesalazine by meta-analysis. Methods Pubmed, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for studies comparing the efficacy and/or tolerance of Balsalazide with mesalazine in the management of UC. The search terms were: “mesalazine” or “5-aminosalicylic acid” and “Balsalazide” and “ulcerative colitis.” Data were collected from 1966 to 2007 (up to February). There was no language restriction. “Symptomatic remission,” “complete remission,” “relapse rate,” “total adverse events,” and “withdrawals because of adverse events” were the key outcomes of interest. Results Six randomized placebo-controlled clinical trials met our criteria and were included in the meta-analysis. In these “symptomatic remission,” “complete remission,” “relapse rate,” “total adverse events,” and “withdrawals because of adverse events” were evaluated in three, three, two, five, and six of the trials, respectively. They included 653 patients consisting of 55.4% men and 44.6% women randomized to receive either Balsalazide or mesalazine. Pooling of three trials for symptomatic remission yielded a significant relative risk (RR) of 1.23 (95% confidence interval of 1.03–1.47, P  = 0.02). The summary RR for complete remission in three trials was 1.3 (95% CI of 1.002–1.68, P  = 0.048). Pooling of two trials for the outcome of relapse yielded a non-significant RR of 0.77 (95% CI of 0.56–1.07, P  = 0.12). Pooling five studies from which data for any adverse events were extracted, yielded a non-significant RR of 0.87 (95% CI of 0.75–1.001, P  = 0.53). The summary RR for withdrawals because of adverse events in six trials was 0.69, a non-significant RR (95% CI of 0.37–1.29, P  = 0.24). Conclusion Balsalazide is more effective than mesalazine in induction of remission, but Balsalazide has no benefit compared with mesalazine in preventing relapse in the population selected. The number of patients with any adverse events and withdrawals because of severe adverse events is similar for mesalazine and Balsalazide.

  • comparison of mesalazine and Balsalazide in induction and maintenance of remission in patients with ulcerative colitis
    2009
    Co-Authors: Roja Rahimi, Shekoufeh Nikfar, Ali Rezaie, Mohammad Abdollahi
    Abstract:

    Background 5-Aminosalicylates are the stan- dard treatment for induction and maintenance of remission in mild-to-moderate ulcerative colitis. In recent years, the 5-aminosalicylic acid-containing pro-drug Balsalazide has been the focus of attention. Aim To compare the efficacy and tolerance of Balsalazide and mesalazine by meta- analysis. Methods Pubmed, Embase, Scopus, Web of Sci- ence, and the Cochrane Central Register of Controlled Trials were searched for studies comparing the efficacy and/or tolerance of Balsalazide with mesalazine in the management of UC. The search terms were: ''mesalazine'' or ''5-aminosalicylic acid'' and ''Balsalazide'' and ''ulcer- ative colitis.'' Data were collected from 1966 to 2007 (up to February). There was no language restriction. ''Symp- tomatic remission,'' ''complete remission,'' ''relapse rate,'' ''total adverse events,'' and ''withdrawals because of adverse events'' were the key outcomes of interest. Results Six randomized placebo-controlled clinical trials met our criteria and were included in the meta-analysis. In these ''symptomatic remission,'' ''complete remission,'' ''relapse rate,'' ''total adverse events,'' and ''withdrawals because of adverse events'' were evaluated in three, three, two, five, and six of the trials, respectively. They included 653 patients consisting of 55.4% men and 44.6% women ran- domized to receive either Balsalazide or mesalazine. Pooling of three trials for symptomatic remission yielded a significant relative risk (RR) of 1.23 (95% confidence interval of 1.03-1.47, P = 0.02). The summary RR for complete remission in three trials was 1.3 (95% CI of 1.002-1.68, P = 0.048). Pooling of two trials for the out- come of relapse yielded a non-significant RR of 0.77 (95% CI of 0.56-1.07, P = 0.12). Pooling five studies from which data for any adverse events were extracted, yielded a non-significant RR of 0.87 (95% CI of 0.75-1.001, P = 0.53). The summary RR for withdrawals because of adverse events in six trials was 0.69, a non-significant RR (95% CI of 0.37-1.29, P = 0.24). Conclusion Balsalazide is more effective than mesalazine in induction of remis- sion, but Balsalazide has no benefit compared with mesalazine in preventing relapse in the population selected. The number of patients with any adverse events and withdrawals because of severe adverse events is similar for mesalazine and Balsalazide.

  • pregnancy outcome in women with inflammatory bowel disease following exposure to 5 aminosalicylic acid drugs a meta analysis
    2008
    Co-Authors: Roja Rahimi, Shekoufeh Nikfar, Ali Rezaie, Mohammad Abdollahi
    Abstract:

    5-ASA drugs are commonly used for management of inflammatory bowel disease (IBD) during pregnancy. The safety of drug therapy for IBD during pregnancy is an important clinical concern. The present meta-analysis was performed to explore the risk of adverse pregnancy outcomes in women with IBD following exposure to 5-ASA drugs (mesalazine, sulfasalazine, Balsalazide, and olsalazine). Bibliographic databases were searched upto June 2007 for studies investigating pregnancy outcomes in women with IBD following exposure to any 5-ASA drugs. The outcomes of interest were congenital abnormalities, stillbirth, spontaneous abortion, preterm delivery, and low birth weight. The odds ratios (OR) and confidence interval (CI) for the individual studies were pooled and heterogeneity analysis was performed. Seven studies with a total of 2200 pregnant women with IBD were included; 642 received 5-ASA drugs (mesalazine, sulfasalazine or olsalazine) and 1158 received no medication. The OR was found 1.16 (95% CI: 0.76-1.77, P=0.57) for congenital abnormalities, 2.38 (95% CI: 0.65-8.72, P=0.32) for stillbirth, 1.14 (95% CI: 0.65-2.01, P=0.74) for spontaneous abortion, 1.35 (95% CI: 0.85-2.13, P=0.26) for preterm delivery, and 0.93 (95% CI: 0.46-1.85, P=0.96) for low birth weight. In conclusion, this meta-analysis suggest that there is no more than an 1.16-fold increase in congenital malformations, an 2.38-fold increase in stillbirth, an 1.14-fold increase in spontaneous abortion, an 1.35-fold increase in preterm delivery, and an 0.93-fold increase in low birth weight.

Jonathan R B Green - One of the best experts on this subject based on the ideXlab platform.

  • D.: Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis
    2015
    Co-Authors: Jonathan R B Green, A J Lobo, Charles D Holdsworth, Roger J Leicester, Katharine J Parkins, M D Taylor, John A. Gibson, Graeme D. Kerr, Humphrey J. F. Hodgson, The Abacus
    Abstract:

    in the treatment of ulcerative colitis (UC). Balsalazide is a novel mesalamine prodrug, activated by colonic bacteria. The aim of this study was to compare the efficacy and safety of Balsalazide with that of a pH-dependent formulation of mesalamine in active UC. Methods: A randomized, double-blind study was per-formed comparing Balsalazide, 6.75 g daily, with me-salamine, 2.4 g daily, administered for 4, 8, or 12 weeks to 101 (99 evaluable) patients with symptom-atic, sigmoidoscopically verified UC. Results: More patients treated with Balsalazide achieved symptom-atic remission after 2 (64 % [Balsalazide] vs. 43% [mesalamine]), 4 (70 % vs. 51%), 8 (78 % vs. 45%), and 12 weeks (88 % vs. 57%) and complete remission (none/mild symptoms, sigmoidoscopy grade 0/1, n

  • short report comparison of two doses of Balsalazide in maintaining ulcerative colitis in remission over 12 months
    2007
    Co-Authors: Jonathan R B Green, J A Gibson, G D Kerr, C H J Swan, A Rowlinson, P Brown, E T Swarbrick, P C Thornton
    Abstract:

    In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive Balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of Balsalazide.

  • patient led variable dosing with Balsalazide as long term therapy for maintenance in ulcerative colitis a 3 year prospective observational study
    2004
    Co-Authors: Jonathan R B Green, J A Gibson, G D Kerr, C H J Swan, E T Swarbrick, P C Thornton
    Abstract:

    Summary Background : The patient-centred approach is new to the management of ulcerative colitis. To date, it has only been shown to be successful in a short-term study. Aim : To assess the feasibility, safety and efficacy of patient-led dosing using Balsalazide in the long-term treatment of ulcerative colitis. Methods : This was a 3-year, two-cohort, multi-centre study: one cohort was in stable remission (52 patients) and the other was newly in remission (76 patients) from ulcerative colitis. Two 750-mg Balsalazide capsules were given twice daily for maintenance, increased by 750-mg increments to a maximum of 6 g for up to 7 days depending on symptom severity. Clinical assessments were made every 12–14 weeks; laboratory assessments were made every 6 months. Results : The average median daily dose of Balsalazide was 3 g (range, 1.5–6 g). In the cohort with stable remission, 23 patients (44%) had relapsed by 3 years [median time to relapse, > 1095 days (36 months)]. In the cohort newly in remission, these values were 45 patients (59%) and 656 days (22 months), respectively. In the cohort with stable remission, the time since last relapse was significantly associated with relapse during the first year of treatment (P < 0.033). Conclusions : Long-term, patient-led, maintenance treatment with Balsalazide is well tolerated with a good safety profile and is effective for patients with ulcerative colitis.

  • Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis
    1998
    Co-Authors: Jonathan R B Green, G D Kerr, A J Lobo, Charles D Holdsworth, Roger J Leicester, John Gibson, Humphrey Hodgson, Katharine J Parkins, M D Taylor
    Abstract:

    Abstract Background & Aims: Aminosalicylates are widely used in the treatment of ulcerative colitis (UC). Balsalazide is a novel mesalamine prodrug, activated by colonic bacteria. The aim of this study was to compare the efficacy and safety of Balsalazide with that of a pH-dependent formulation of mesalamine in active UC. Methods: A randomized, double-blind study was performed comparing Balsalazide, 6.75 g daily, with mesalamine, 2.4 g daily, administered for 4, 8, or 12 weeks to 101 (99 evaluable) patients with symptomatic, sigmoidoscopically verified UC. Results: More patients treated with Balsalazide achieved symptomatic remission after 2 (64% [Balsalazide] vs. 43% [mesalamine]), 4 (70% vs. 51%), 8 (78% vs. 45%), and 12 weeks (88% vs. 57%) and complete remission (none/mild symptoms, sigmoidoscopy grade 0/1, no rectal steroid use within 4 days) after 4 (38% vs. 12%), 8 (54% vs. 22%), and 12 weeks (62% vs. 37%). Patients taking Balsalazide experienced more asymptomatic days (4 weeks, 24% vs. 14%) and achieved the first asymptomatic day more rapidly (median, 10 vs. 25 days). Fewer patients in the Balsalazide group reported adverse events (48% vs. 71%); four serious adverse events occurred in the mesalamine group. Conclusions: Balsalazide is more effective and better tolerated than mesalamine as treatment for acute UC. GASTROENTEROLOGY 1998;114:15-22