Coated Oral 5-Aminosalicylic Acid (Claversal) Is Equivalent to Sulfasalazine for Remission Maintenance in Ulcerative Colitis

Ardizzone, Sandro; Petrillo, M.; Molteni, Paola; Desideri, Serena; Porro, G. Bianchi

doi:10.1097/00004836-199512000-00007

Cited by 50 publications

(41 citation statements)

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“…Analysis of 14 trials of maintenance therapy with mesalazine of 1 year duration show great variability, with relapse rates from 23%–63% 12–24. The mean relapse rate of these pooled trials (involving 1540 patients) was 42%.…”

Section: Methodsmentioning

confidence: 99%

One-year investigator-blind randomized multicenter trial comparing asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis

Hawthorne

Stenson

Gillespie

et al. 2012

Inflammatory Bowel Diseases

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BackgroundMesalazine (Asacol) is still widely prescribed in divided doses for ulcerative colitis (UC), despite evidence that adherence is improved by once-daily (OD) prescribing. We aimed to investigate whether OD Asacol was as effective as three times (TDS) daily dosing, and to evaluate the role of treatment adherence.MethodsAn investigator-blind randomized trial was undertaken comparing OD Asacol (three 800 mg tablets) versus one 800 mg TDS in maintenance of remission of UC over 1 year. The primary endpoint was relapse rate, and noninferiority would be concluded if the lower limit of the two-sided 95% confidence interval (CI) of the difference in proportions relapsing (TDS-OD) exceeded −10%. Adherence was measured by tablet counts and self-reported adherence. A subgroup of patients used a bottle cap that recorded all bottle opening events.ResultsIn all, 213 patients were randomized. In the intention-to-treat (ITT) population, relapse rates were 31% (95% CI 22%–40%) in the OD and 45% (95% CI 35%–54%) in the TDS group. Primary analysis confirmed the noninferiority of OD dosing. Two of the study populations, ITT and per-protocol (PP), showed potential superiority of OD dosing. All measures of adherence showed that it was significantly better in the OD group. Multivariate analysis, however, showed OD dosing was associated with lower relapse risk independently of adherence.ConclusionsOD dosing with Asacol 2.4 g is as safe and effective as TDS dosing, and secondary analysis confirmed significantly reduced relapse rates. The benefit, however, was clinically borderline and may relate in part to ease of adherence. (Inflamm Bowel Dis 2012)

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Section: Methodsmentioning

confidence: 99%

One-year investigator-blind randomized multicenter trial comparing asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis

Hawthorne

Stenson

Gillespie

et al. 2012

Inflammatory Bowel Diseases

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“…[3][4][5] To induce and maintain remission, medical treatment is often needed during both asymptomatic and symptomatic stages of the disease. [6][7][8][9][10][11][12][13] Lack of adherence to medical treatment is arbitrarily defined as less than 80% intake of the daily prescribed dose of medicine. 14 No studies have investigated prevalence rates of nonadherence to medical treatment among pregnant women with UC.…”

mentioning

confidence: 99%

Self-reported adherence to medical treatment prior to and during pregnancy among women with ulcerative colitis

Julsgaard

Nørgaard

Hvas

et al. 2011

Inflammatory Bowel Diseases

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“…1) [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]. Of these 20 studies, 19 obtained acceptable Jadad score of 3 or more [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] ( Table 1). Using Cochran's Q test of heterogeneity, it was found that this study was homogenous with the rest of the studies and was not excluded.…”

Section: Resultsmentioning

confidence: 99%

“…The summary RR for withdrawals because of adverse events in eight trials [24,[29][30][31][36][37][38][39] was 0.78 (95% CI 0.46-1.3), a nonsignificant RR (P = 0.33) ( Table 3, Fig. 5).…”

Section: Efficacymentioning

confidence: 99%

A Meta-Analysis of the Efficacy of Sulfasalazine in Comparison with 5-Aminosalicylates in the Induction of Improvement and Maintenance of Remission in Patients with Ulcerative Colitis

et al. 2008

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SSZ does not differ from mesalamine or olsalazine in terms of efficacy and tolerability in UC. Withdrawal from study due to adverse events was significantly lower for balsalazide compared with SSZ. Convincing conclusions on the comparison of effectiveness and safety of balsalazide and SSZ in UC remains to be elucidated by further clinical trials. Considering the lower cost of treatment with SSZ and the equal rate of adverse events with other 5-ASAa, it is not surprising to suggest SSZ as a first-choice treatment for UC and reserve 5-ASAs for when SSZ intolerability occurs.

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Coated Oral 5-Aminosalicylic Acid (Claversal) Is Equivalent to Sulfasalazine for Remission Maintenance in Ulcerative Colitis

Cited by 50 publications

References 0 publications

One-year investigator-blind randomized multicenter trial comparing asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis

One-year investigator-blind randomized multicenter trial comparing asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis

Self-reported adherence to medical treatment prior to and during pregnancy among women with ulcerative colitis

A Meta-Analysis of the Efficacy of Sulfasalazine in Comparison with 5-Aminosalicylates in the Induction of Improvement and Maintenance of Remission in Patients with Ulcerative Colitis

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