Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis

Courtney, Michael; Nunes, Daniella Pires; Bergin, C.; O'Driscoll, Mervyn; Trimble, Valerie; Keeling, P. W. N.; Weir, Donald G.

doi:10.1016/0140-6736(92)91601-4

Cited by 85 publications

(28 citation statements)

References 25 publications

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“…In patients with left-sided active UC, clinical trials support the theoretical proposal that drugs delivering 5 aminosalicylate (5-ASA) primarily to the colon ( olsalazine, balsalazide) may be more effective than those from which 5-ASA is released more proximally, e. g. Asacol [21,22] .…”

Section: Aminosalicylates (Table 1)mentioning

confidence: 64%

New treatments for inflammatory bowel disease

S¹

1998

WJG

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Section: Aminosalicylates (Table 1)mentioning

confidence: 64%

New treatments for inflammatory bowel disease

S¹

1998

WJG

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“…As yet, there are only two published maintenance trials comparing different 5-ASA drugs 313 Comparisons of the relapse preventing capacity of Eudragit S coated mesalazine with that of the two prodrugs olsalazine and balsalazide showed (for 12 months) significant therapeutic superiority of olsalazine3 and similar efficacy of balsalazide,13 respectively.…”

Section: Discussionmentioning

confidence: 99%

Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses

Kruis

2001

Gut

104

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Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses Results-Balsalazide 3.0 g twice daily resulted in a significantly higher clinical remission rate (77.5%) than balsalazide 1.5 g twice daily (43.8%) and mesalazine 0.5 g three times daily (56.8%) (p=0.006). The respective times to relapse were 161 days, 131 days (p=0.003), and 144 days (NS). Accordingly, pairwise contrasts of the final endoscopic score demonstrated a significant diVerence (p=0.005) between the two balsalazide treatment groups while diVerences between either of these two groups and mesalazine were not statistically significant. Patients treated with balsalazide excreted less 5-ASA and N-Ac-5-ASA than patients receiving mesalazine but these diVerences were not statistically significant. Discontinuation of the trial because of adverse eVects occurred in nine patients: three in the balsalazide 1.5 g twice daily group, two in the balsalazide 3.0 g twice daily group, and four in the mesalazine 0.5 g three times daily group. No clinically important new drug safety related findings were identified in this study. Conclusions-High dose balsalazide (3.0 g twice daily) was superior in maintaining remission in patients with ulcerative colitis compared with a low dose (1.5 g twice daily) or a standard dose of mesalazine (0.5 g three times daily). All three treatments were safe and well tolerated. (Gut 2001;49:783-789)

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“…Few trials have compared different oral 5-ASA compounds. Two have suggested an advantage of azo compounds over delayed-release mesalazine [19,20]; however, most data indicate equivalence between the available oral aminosalicylates.…”

Section: Management Of Mild-to-moderate Ulcerative Colitismentioning

confidence: 99%

Standard Treatment of Ulcerative Colitis

Gionchetti

Rizzello

Habal

et al. 2003

Dig Dis

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Ulcerative colitis (UC) is an idiopathic, chronic inflammation of the colon which may present with a range of mild to severe symptoms. The disease may be localized to the rectum or can be more extensive and involve the left side of the colon or the whole colon. Treatment in UC is directed towards inducing and maintaining remission of symptoms and mucosal inflammation. The key parameters to be assessed for the most appropriate treatment are the severity and extent of the inflammation. Meta-analyses of published trials have shown that topical treatment with 5-aminosalicylic acid (5-ASA) is the treatment of choice in active distal mild-to-moderate UC. Oral aminosalicylates are effective in both distal and extensive mild-to-moderate disease, but in distal disease, the rates of remission are lower than those obtained with topical 5-ASA. New steroids, such as budesonide and beclomethasone dipropionate (BDP), administered as enemas, constitute an alternative to 5-ASA therapy. In some studies, these have been shown to be as effective as conventional steroids but with significantly lower inhibition of plasma cortisol levels. Patients with unresponsive disease or those with more severe presentation will require oral corticosteroids and sometimes intravenous therapy. Approximately 10% of patients with unresponsive UC have severe attacks requiring hospitalization. Patients with severe disease should be managed jointly by a medical and surgical team, and intensive intravenous treatment should be started with high-dose steroids. Early recognition of failure of therapy will allow the introduction of immunosuppressive therapy with intravenous cyclosporine. Patients who respond are shifted to oral cyclosporine associated with azathioprine/6-mercaptopurine, whereas those who fail will require proctocolectomy. Oral aminosalicylates are the first-line therapy in maintenance of remission. Topical 5-ASA may play a role in distal disease. Patients who are steroid dependent can be started on azathioprine or 6-mercaptopurine although it may take up to 3 months for the treatment to become effective. They may have reversible immediate side effects, such as pancreatitis or bone marrow suppression, which disappear upon discontinuation of therapy. Close monitoring of these hematologic and biochemical parameters will improve safety. The use of biologic therapy with infliximab in more severe disease has not been established.

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Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis

Cited by 85 publications

References 25 publications

New treatments for inflammatory bowel disease

New treatments for inflammatory bowel disease

Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses

Standard Treatment of Ulcerative Colitis

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