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Titolo:
Olsalazine is not superior to placebo in maintaining remission of inactiveCrohn's colitis and ileocolitis: a double blind, parallel, randomised, multicentre study
Autore:
Mahmud, N; Kamm, MA; Dupas, JL; Jewell, DP; OMorain, CA; Weir, DG; Kelleher, D;
Indirizzi:
St James Hosp, Trinity Coll, Dept Clin Med, Trinity Ctr Hlth Sci, Dublin 8, Ireland St James Hosp Dublin Ireland 8 , Trinity Ctr Hlth Sci, Dublin 8, Ireland St Marks Hosp, Dept Med & Gastroenterol, Northwick Pk, England St Marks Hosp Northwick Pk England Gastroenterol, Northwick Pk, England Hosp Nord, Dept Med & Gastroenterol, Amiens, France Hosp Nord Amiens France Nord, Dept Med & Gastroenterol, Amiens, France Radcliffe Infirm, Gastroenterol Unit, Oxford OX2 6HE, England Radcliffe Infirm Oxford England OX2 6HE ol Unit, Oxford OX2 6HE, England Meath & Adelaide Hosp, Trinity Coll, Dept Clin Med, Dublin, Ireland Meath & Adelaide Hosp Dublin Ireland ll, Dept Clin Med, Dublin, Ireland
Titolo Testata:
GUT
fascicolo: 4, volume: 49, anno: 2001,
pagine: 552 - 556
SICI:
0017-5749(200110)49:4<552:OINSTP>2.0.ZU;2-S
Fonte:
ISI
Lingua:
ENG
Soggetto:
5-AMINOSALICYLIC ACID; ULCERATIVE-COLITIS; MAINTENANCE TREATMENT; HEALTHY-VOLUNTEERS; AZODISAL SODIUM; DISEASE; MESALAMINE; TRIAL; SULFASALAZINE; PROPHYLAXIS;
Keywords:
olsalazine; Crohn's disease; colitis; ileocolitis;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
22
Recensione:
Indirizzi per estratti:
Indirizzo: Mahmud, N St James Hosp, Trinity Coll, Dept Clin Med, Trinity Ctr Hlth Sci, Dublin 8, Ireland St James Hosp Dublin Ireland 8 Ctr Hlth Sci, Dublin 8, Ireland
Citazione:
N. Mahmud et al., "Olsalazine is not superior to placebo in maintaining remission of inactiveCrohn's colitis and ileocolitis: a double blind, parallel, randomised, multicentre study", GUT, 49(4), 2001, pp. 552-556

Abstract

Background and aims-The benefit of 5-aminosalicylic acid therapy for maintenance of remission in Crohn's disease is controversial. The primary aim ofthis study was to evaluate the prophylactic properties of olsalazine in comparison with placebo for maintenance of remission in quiescent Crohn's colitis and/or ileocolitis. Methods-In this randomised, double blind, parallel group study of olsalazine versus placebo, 328 patients with quiescent Crohn's colitis and/or ileocolitis were recruited. Treatment consisted of olsalazine 2.0 g daily or placebo for 52 weeks. The primary end point of efficacy was relapse, as defined by the Crohn's disease activity index (CDAI) and by clinical relapse. Laboratory and clinical disease activity indicators were also measured. Safetyanalysis consisted of documentation of adverse events and laboratory values. Results-No differences in the frequency of termination due to relapse or time to termination due to relapse were noted between the two treatment groups (olsalazine 48.5% upsilon placebo 45%) for either colitis or ileocolitis. The failure rate, defined as not completing the study, was significantly higher in olsalazine treated patients compared with placebo treated patients for the overall population (colitis and/or ileocolitis: olsalazine 65.4% upsilon 53.9%; p=0.038). Similar failure rates were seen for patients with colitis. A significantly higher percentage of olsalazine treated patients experienced adverse gastrointestinal events. Drug attributed adverse events were reported more frequently in the olsalazine treated group with gastrointestinal symptoms being causally related to olsalazine treatment (olsalazine 40.7% upsilon placebo 26.9%; p=0.010). Back pain was reported significantly more often by the placebo treated group. However, serious medical eventsdid not differ between the two groups. Adverse events led to more early withdrawals in the olsalazine treated group than in the placebo treated group; thus average time in the study for patients in the olsalazine treatment group was significantly shorter than that of patients in the placebo group. Conclusions-Patients treated with olsalazine were more likely to terminatetheir participation in the trial than those taking placebo. This difference was not related to relapse of disease, as measured by CDAI and clinical measures, but rather was due to the development of intolerable adverse medical events of a non-serious nature related to the gastrointestinal tract. The gastrointestinal related events in the olsalazine treated group may be due to the difference in gastrointestinal status at baseline which favoured the placebo treatment group.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/09/20 alle ore 19:35:00