Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis
To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine. Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission...
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| Veröffentlicht in: | European journal of gastroenterology & hepatology 1995-05, Vol.7 (5), p.391-396 |
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| container_title | European journal of gastroenterology & hepatology |
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| creator | KRUIS, W JUDMAIER, G KAYASSEH, L STOLTE, M THEUER, D SCHEURLEN, C HENTSCHEL, E KRATOCHVIL, P |
| description | To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine.
Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative colitis.
Public hospitals and private practices in Germany, Austria and Switzerland.
A total of 162 patients with ulcerative colitis in remission.
According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily).
This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine. |
| format | Article |
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Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative colitis.
Public hospitals and private practices in Germany, Austria and Switzerland.
A total of 162 patients with ulcerative colitis in remission.
According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily).
This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.</description><identifier>ISSN: 0954-691X</identifier><identifier>EISSN: 1473-5687</identifier><identifier>PMID: 7614099</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Adolescent ; Adult ; Aged ; Aminosalicylic Acids - administration & dosage ; Aminosalicylic Acids - adverse effects ; Aminosalicylic Acids - therapeutic use ; Biological and medical sciences ; Colitis, Ulcerative - prevention & control ; Diarrhea - chemically induced ; Digestive system ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Recurrence ; Remission Induction ; Safety ; Sulfasalazine - administration & dosage ; Sulfasalazine - adverse effects ; Sulfasalazine - therapeutic use ; Treatment Failure ; Treatment Outcome</subject><ispartof>European journal of gastroenterology & hepatology, 1995-05, Vol.7 (5), p.391-396</ispartof><rights>1995 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=3675083$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/7614099$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KRUIS, W</creatorcontrib><creatorcontrib>JUDMAIER, G</creatorcontrib><creatorcontrib>KAYASSEH, L</creatorcontrib><creatorcontrib>STOLTE, M</creatorcontrib><creatorcontrib>THEUER, D</creatorcontrib><creatorcontrib>SCHEURLEN, C</creatorcontrib><creatorcontrib>HENTSCHEL, E</creatorcontrib><creatorcontrib>KRATOCHVIL, P</creatorcontrib><title>Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis</title><title>European journal of gastroenterology & hepatology</title><addtitle>Eur J Gastroenterol Hepatol</addtitle><description>To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine.
Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative colitis.
Public hospitals and private practices in Germany, Austria and Switzerland.
A total of 162 patients with ulcerative colitis in remission.
According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily).
This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aminosalicylic Acids - administration & dosage</subject><subject>Aminosalicylic Acids - adverse effects</subject><subject>Aminosalicylic Acids - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Colitis, Ulcerative - prevention & control</subject><subject>Diarrhea - chemically induced</subject><subject>Digestive system</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Recurrence</subject><subject>Remission Induction</subject><subject>Safety</subject><subject>Sulfasalazine - administration & dosage</subject><subject>Sulfasalazine - adverse effects</subject><subject>Sulfasalazine - therapeutic use</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><issn>0954-691X</issn><issn>1473-5687</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1995</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9T01LxDAUDKKsdfUnCDl4DSSbpmmOsn7CghcFb8tL8uJGsm1t2oX66y247GnmzQzDmzNSiFJLpqpan5OCG1WyyojPS3KV8zfnQkuhF2ShK1FyYwry89CONiGzKTae-jYjCzOLzRfNw-gn2gbapgwJfmOD9IB9HjPNY-p2cFIh0z3EZsAGGod02GEP3URD29MxufkY4gGpa1McYr4mFwFSxpsjLsnH0-P7-oVt3p5f1_cb1gnFBxZ4UJWyclV7gcYhGpRgDXrtuF8pqwSKWnoXajDWiICydIqXUAfunZNcLsntf2832j36bdfHPfTT9jh99u-OPmQHKfTz7zGfYrLSitdS_gGHD2cB</recordid><startdate>199505</startdate><enddate>199505</enddate><creator>KRUIS, W</creator><creator>JUDMAIER, G</creator><creator>KAYASSEH, L</creator><creator>STOLTE, M</creator><creator>THEUER, D</creator><creator>SCHEURLEN, C</creator><creator>HENTSCHEL, E</creator><creator>KRATOCHVIL, P</creator><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>199505</creationdate><title>Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis</title><author>KRUIS, W ; JUDMAIER, G ; KAYASSEH, L ; STOLTE, M ; THEUER, D ; SCHEURLEN, C ; HENTSCHEL, E ; KRATOCHVIL, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p150t-f0f565b328d1e9cee9e3ab9ed7c0d25b51e183dcf8a9b91fe34c504a8f0dcc303</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1995</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aminosalicylic Acids - administration & dosage</topic><topic>Aminosalicylic Acids - adverse effects</topic><topic>Aminosalicylic Acids - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Colitis, Ulcerative - prevention & control</topic><topic>Diarrhea - chemically induced</topic><topic>Digestive system</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Recurrence</topic><topic>Remission Induction</topic><topic>Safety</topic><topic>Sulfasalazine - administration & dosage</topic><topic>Sulfasalazine - adverse effects</topic><topic>Sulfasalazine - therapeutic use</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>KRUIS, W</creatorcontrib><creatorcontrib>JUDMAIER, G</creatorcontrib><creatorcontrib>KAYASSEH, L</creatorcontrib><creatorcontrib>STOLTE, M</creatorcontrib><creatorcontrib>THEUER, D</creatorcontrib><creatorcontrib>SCHEURLEN, C</creatorcontrib><creatorcontrib>HENTSCHEL, E</creatorcontrib><creatorcontrib>KRATOCHVIL, P</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>European journal of gastroenterology & hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>KRUIS, W</au><au>JUDMAIER, G</au><au>KAYASSEH, L</au><au>STOLTE, M</au><au>THEUER, D</au><au>SCHEURLEN, C</au><au>HENTSCHEL, E</au><au>KRATOCHVIL, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis</atitle><jtitle>European journal of gastroenterology & hepatology</jtitle><addtitle>Eur J Gastroenterol Hepatol</addtitle><date>1995-05</date><risdate>1995</risdate><volume>7</volume><issue>5</issue><spage>391</spage><epage>396</epage><pages>391-396</pages><issn>0954-691X</issn><eissn>1473-5687</eissn><abstract>To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine.
Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative colitis.
Public hospitals and private practices in Germany, Austria and Switzerland.
A total of 162 patients with ulcerative colitis in remission.
According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily).
This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>7614099</pmid><tpages>6</tpages></addata></record> |
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| identifier | ISSN: 0954-691X |
| ispartof | European journal of gastroenterology & hepatology, 1995-05, Vol.7 (5), p.391-396 |
| issn | 0954-691X 1473-5687 |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Adolescent Adult Aged Aminosalicylic Acids - administration & dosage Aminosalicylic Acids - adverse effects Aminosalicylic Acids - therapeutic use Biological and medical sciences Colitis, Ulcerative - prevention & control Diarrhea - chemically induced Digestive system Double-Blind Method Female Follow-Up Studies Humans Male Medical sciences Middle Aged Pharmacology. Drug treatments Recurrence Remission Induction Safety Sulfasalazine - administration & dosage Sulfasalazine - adverse effects Sulfasalazine - therapeutic use Treatment Failure Treatment Outcome |
| title | Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis |
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