Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis

Pruitt, Ronald E.; Hanson, John S.; Safdi, Michael; Wruble, Lawrence D.; Hardi, Robert; Johanson, John F.; Koval, George; Riff, Dennis; Winston, Barry; Cross, Amanda J.; Doty, Pamela; Johnson, Lorin K.

doi:10.1016/s0016-5085(00)82561-5

Cited by 12 publications

(8 citation statements)

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“…The delivery system, via the colonic bacterial azoreductase, is not the subject of this study as both active treatments employed this mechanism; the differences between the treatments involved the toxicity of the carrier molecule and the dose of 5‐aminosalicylic acid delivered. Other studies have compared the azo‐bond reductase delivery system with pH‐dependent release and time‐dependent release in the setting of mild to moderate colitis 13–15 . Although the designs of these studies were different, when considered with the results of this study, it can be concluded that sulfasalazine is insufficiently tolerated to be the drug of choice and pH‐dependent release mesalazine (Asacol) may be less reliably delivered to the diseased colon than balsalazide, which consistently appears to be effective and well tolerated.…”

Section: Discussionmentioning

confidence: 89%

“…The inert nature of the carrier molecule, in contrast to sulfasalazine, may allow more patients to tolerate the treatment and higher doses of 5‐aminosalicylic acid to be delivered to the colon. Published trials with balsalazide have shown it to be superior to mesalazine in the induction of remission, 13–15 and as effective as sulfasalazine and mesalazine in the maintenance of remission 16 , . 17 Trial data comparing balsalazide to sulfasalazine in active disease are limited to the abstract reports of this and one other study 18 , .…”

Section: Introductionmentioning

confidence: 99%

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A double‐blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis

Mansfield

Giaffer

Cann

et al. 2002

Aliment Pharmacol Ther

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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.

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

A double‐blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis

Mansfield

Giaffer

Cann

et al. 2002

Aliment Pharmacol Ther

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“…It is also licensed for, and effective in, the maintenance of remission in ulcerative colitis 13 , . 14 Previously published trials suggest that it is superior to mesalazine (5‐aminosalicylic acid) delivered by a pH‐dependent coating (Asacol) in achieving remission in active disease 15–17 . Apart from one other study, using balsalazide or sulfasalazine as the sole initial therapy of mild to moderate active colitis (published in abstract form), 18 there are no other data to compare balsalazide and sulfasalazine directly in patients with active ulcerative colitis.…”

Section: Introductionmentioning

confidence: 99%

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

Green

Mansfield

Gibson³

et al. 2002

Aliment Pharmacol Ther

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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.

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“…1,2 The first-line therapies for the induction and maintenance of remission in patients with mild-to-moderate ulcerative colitis are aminosalicylates, including mesalamine formulations and the pro-drugs sulfasalazine, olsalazine, and balsalazide. [3][4][5][6][7][8][9] The beneficial effects of these drugs are attributed to 5-aminosalicylic acids (5-ASAs; mesalamine). Unlike mesalamine, the pro-drugs sulfasalazine, olsalazine, and balsalazide all have an azo linkage, allowing the compound to pass through the small intestine unchanged to arrive in the colon where they are metabolized by colonic bacterial azoreductase to release 5-ASA ( Fig.…”

mentioning

confidence: 99%

Comparative Analysis of the in Vitro Prosecretory Effects of Balsalazide, Sulfasalazine, Olsalazine, and Mesalamine in Rabbit Distal Ileum

Kles¹,

Vavricka²,

Turner³

et al. 2005

Inflammatory Bowel Diseases

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Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis

Cited by 12 publications

References 0 publications

A double‐blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis

A double‐blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of 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

Comparative Analysis of the in Vitro Prosecretory Effects of Balsalazide, Sulfasalazine, Olsalazine, and Mesalamine in Rabbit Distal Ileum

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