Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis
Sulphasalazine extends remissions and lessens disease activity during relapses of ulcerative colitis, but it also causes many adverse side-effects. The adverse reactions are mostly attributable to the sulphapyridine carrier moiety rather than the active principle 5-aminosalicylic acid (5-ASA), so ag...
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| Veröffentlicht in: | The Lancet (British edition) 1992-05, Vol.339 (8804), p.1279-1281 |
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| creator | Courtney, M.G. Nunes, D.P. Bergin, C.F. O'Driscoll, M. Trimble, V. Keeling, P.W.N. Weir, D.G. |
| description | Sulphasalazine extends remissions and lessens disease activity during relapses of ulcerative colitis, but it also causes many adverse side-effects. The adverse reactions are mostly attributable to the sulphapyridine carrier moiety rather than the active principle 5-aminosalicylic acid (5-ASA), so agents to deliver 5-ASA to the colon by other means have been designed. We have compared the efficacy and tolerability of two such agents, olsalazine and mesalazine, in maintenance therapy of ulcerative colitis. 100 patients with ulcerative colitis in remission were recruited at one centre and assigned randomly to treatment with olsalazine (Dipentum; 1·0 g daily) or mesalazine (Asacol, with Eudragit-S coating; 1·2 g daily). Compliance, biochemical and haematological variables, and clinical evidence of disease activity were assessed every 3 months for 12 months by observers unaware of treatment allocation. In intention-to-treat analysis, which included as treatment failures patients withdrawn for protocol violations, adverse reactions, intercurrent illness, or non-compliance as well as those with relapses of ulcerative colitis, the olsalazine group had a significantly lower rate of treatment failure than the mesalazine group (12/49 [24%] vs 23/50 [46%]; p=0·025). Analysis restricted to 64 patients still in remission at 1 year and 18 with relapses also showed a significant difference in relapse rate (olsalazine 5/42 [12%] vs mesalazine 13/40 [33%]; p = 0·024). Both drugs were well tolerated; only 9 patients reported substantial side-effects. Olsalazine was clearly superior to mesalazine in prevention of relapses in ulcerative colitis, especially in patients with left-sided disease. |
| doi_str_mv | 10.1016/0140-6736(92)91601-4 |
| format | Article |
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The adverse reactions are mostly attributable to the sulphapyridine carrier moiety rather than the active principle 5-aminosalicylic acid (5-ASA), so agents to deliver 5-ASA to the colon by other means have been designed. We have compared the efficacy and tolerability of two such agents, olsalazine and mesalazine, in maintenance therapy of ulcerative colitis. 100 patients with ulcerative colitis in remission were recruited at one centre and assigned randomly to treatment with olsalazine (Dipentum; 1·0 g daily) or mesalazine (Asacol, with Eudragit-S coating; 1·2 g daily). Compliance, biochemical and haematological variables, and clinical evidence of disease activity were assessed every 3 months for 12 months by observers unaware of treatment allocation. In intention-to-treat analysis, which included as treatment failures patients withdrawn for protocol violations, adverse reactions, intercurrent illness, or non-compliance as well as those with relapses of ulcerative colitis, the olsalazine group had a significantly lower rate of treatment failure than the mesalazine group (12/49 [24%] vs 23/50 [46%]; p=0·025). Analysis restricted to 64 patients still in remission at 1 year and 18 with relapses also showed a significant difference in relapse rate (olsalazine 5/42 [12%] vs mesalazine 13/40 [33%]; p = 0·024). Both drugs were well tolerated; only 9 patients reported substantial side-effects. Olsalazine was clearly superior to mesalazine in prevention of relapses in ulcerative colitis, especially in patients with left-sided disease.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/0140-6736(92)91601-4</identifier><identifier>PMID: 1349676</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aminosalicylic Acids - therapeutic use ; Biological and medical sciences ; Colitis, Ulcerative - drug therapy ; Digestive system ; Drugs ; Female ; Humans ; Life Tables ; Male ; Medical disorders ; Medical research ; Medical sciences ; Mesalamine ; Middle Aged ; Patient Compliance ; Pharmacology. 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The adverse reactions are mostly attributable to the sulphapyridine carrier moiety rather than the active principle 5-aminosalicylic acid (5-ASA), so agents to deliver 5-ASA to the colon by other means have been designed. We have compared the efficacy and tolerability of two such agents, olsalazine and mesalazine, in maintenance therapy of ulcerative colitis. 100 patients with ulcerative colitis in remission were recruited at one centre and assigned randomly to treatment with olsalazine (Dipentum; 1·0 g daily) or mesalazine (Asacol, with Eudragit-S coating; 1·2 g daily). Compliance, biochemical and haematological variables, and clinical evidence of disease activity were assessed every 3 months for 12 months by observers unaware of treatment allocation. In intention-to-treat analysis, which included as treatment failures patients withdrawn for protocol violations, adverse reactions, intercurrent illness, or non-compliance as well as those with relapses of ulcerative colitis, the olsalazine group had a significantly lower rate of treatment failure than the mesalazine group (12/49 [24%] vs 23/50 [46%]; p=0·025). Analysis restricted to 64 patients still in remission at 1 year and 18 with relapses also showed a significant difference in relapse rate (olsalazine 5/42 [12%] vs mesalazine 13/40 [33%]; p = 0·024). Both drugs were well tolerated; only 9 patients reported substantial side-effects. Olsalazine was clearly superior to mesalazine in prevention of relapses in ulcerative colitis, especially in patients with left-sided disease.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aminosalicylic Acids - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Digestive system</subject><subject>Drugs</subject><subject>Female</subject><subject>Humans</subject><subject>Life Tables</subject><subject>Male</subject><subject>Medical disorders</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Mesalamine</subject><subject>Middle Aged</subject><subject>Patient Compliance</subject><subject>Pharmacology. 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Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Courtney, M.G.</au><au>Nunes, D.P.</au><au>Bergin, C.F.</au><au>O'Driscoll, M.</au><au>Trimble, V.</au><au>Keeling, P.W.N.</au><au>Weir, D.G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>1992-05-23</date><risdate>1992</risdate><volume>339</volume><issue>8804</issue><spage>1279</spage><epage>1281</epage><pages>1279-1281</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Sulphasalazine extends remissions and lessens disease activity during relapses of ulcerative colitis, but it also causes many adverse side-effects. The adverse reactions are mostly attributable to the sulphapyridine carrier moiety rather than the active principle 5-aminosalicylic acid (5-ASA), so agents to deliver 5-ASA to the colon by other means have been designed. We have compared the efficacy and tolerability of two such agents, olsalazine and mesalazine, in maintenance therapy of ulcerative colitis. 100 patients with ulcerative colitis in remission were recruited at one centre and assigned randomly to treatment with olsalazine (Dipentum; 1·0 g daily) or mesalazine (Asacol, with Eudragit-S coating; 1·2 g daily). Compliance, biochemical and haematological variables, and clinical evidence of disease activity were assessed every 3 months for 12 months by observers unaware of treatment allocation. In intention-to-treat analysis, which included as treatment failures patients withdrawn for protocol violations, adverse reactions, intercurrent illness, or non-compliance as well as those with relapses of ulcerative colitis, the olsalazine group had a significantly lower rate of treatment failure than the mesalazine group (12/49 [24%] vs 23/50 [46%]; p=0·025). Analysis restricted to 64 patients still in remission at 1 year and 18 with relapses also showed a significant difference in relapse rate (olsalazine 5/42 [12%] vs mesalazine 13/40 [33%]; p = 0·024). Both drugs were well tolerated; only 9 patients reported substantial side-effects. Olsalazine was clearly superior to mesalazine in prevention of relapses in ulcerative colitis, especially in patients with left-sided disease.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><pmid>1349676</pmid><doi>10.1016/0140-6736(92)91601-4</doi><tpages>3</tpages></addata></record> |
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| subjects | Adolescent Adult Aged Aminosalicylic Acids - therapeutic use Biological and medical sciences Colitis, Ulcerative - drug therapy Digestive system Drugs Female Humans Life Tables Male Medical disorders Medical research Medical sciences Mesalamine Middle Aged Patient Compliance Pharmacology. Drug treatments Prevention Recurrence Remission Induction Side effects Therapy |
| title | Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis |
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