Aminosalicylates for active disease and in the maintenance of remission in Crohn's disease

Feagan, Brian G.

doi:10.1080/110241598750005066

Cited by 12 publications

(4 citation statements)

References 13 publications

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“…Clinicians should be aware that no 5‐ASA product has Food and Drug Administration approval for the treatment of Crohn's disease. Most published 3 , 4 , 6–8 , 35 and several unpublished studies 36 of 5‐ASA products do not show benefit over placebo for induction of remission, although several trials 3 , 4 , 8 , 36 demonstrated a small, but statistically significant decrease in total CDAI score when 5‐ASA is compared to placebo. Conventional corticosteroids remain the treatment of choice for many clinicians, but it is clear that budesonide has superior tolerability in comparison to these drugs with no demonstrated difference in effectiveness among patients who present with low disease activity (CDAI = 200–300).…”

Section: Discussionmentioning

confidence: 99%

Systematic review: the effectiveness of budesonide therapy for Crohn's disease

Kane

Schoenfeld

Sandborn

et al. 2002

Aliment Pharmacol Ther

111

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Summary Aim : To assess the effectiveness and safety of budesonide in comparison to corticosteroids, 5‐aminosalicylic acid (5‐ASA), or placebo for inducing remission of active Crohn's disease and for maintaining remission. Study selection criteria : Randomized controlled trials comparing budesonide to corticosteroids, 5‐ASA products or placebo were included. Trials had to report on the effectiveness of treatment (defined as decreasing or maintaining Crohn's Disease Activity Index, CDAI, scores ≤ 150) or adverse events. Data analysis : After assessing the validity of study design and independent, duplicate data extraction from selected trials, summary relative risks (RR) were calculated for each outcome. A test of heterogeneity was also calculated for each outcome using a random effects model. Results : Budesonide was more likely to induce remission than placebo (RR=1.82, 95% CI: 1.15–2.88) or 5‐ASA (RR=1.73, 95% CI: 1.26–2.39), although only one trial compared budesonide to 5‐ASA products. Although budesonide induced remission less frequently than conventional corticosteroids (RR=0.87, 95% CI: 0.76–0.995), there was no significant difference between conventional corticosteroids and budesonide for inducing remission among patients with a low disease activity (initial CDAI=200–300). Budesonide was significantly less likely to cause corticosteroid‐associated adverse events than conventional corticosteroids (RR=0.65, 95% CI: 0.53–0.80). No significant difference in total adverse events or corticosteroid‐associated adverse events was demonstrated between budesonide and 5‐ASA or placebo. Conclusion : Budesonide is significantly more effective than placebo or 5‐ASA for inducing remission of active Crohn's disease. Although budesonide is 13% less effective for the induction of remission in active Crohn's disease than conventional corticosteroids, it is less likely to cause corticosteroid‐related adverse effects. Budesonide is ineffective in maintaining remission.

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Section: Discussionmentioning

confidence: 99%

Systematic review: the effectiveness of budesonide therapy for Crohn's disease

Kane

Schoenfeld

Sandborn

et al. 2002

Aliment Pharmacol Ther

111

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“…Sulfasalazine has not been consistently e ective for patients with active disease limited to the small intestine (92 -94) . Clinical trials have not been of su cient size to adequately compare sulfasalazine to alternative aminosalicylates (95) . Although di erent formulations of mesalamine have been shown to bene t patients in the acute treatment of mild to moderate CD (96 -98) at doses of 3.2 -4.0 g daily, several of the studies are of poor methodological quality (96,97) and a metaanalysis of three large trials with mesalamine, 4 g daily, demonstrated a statistically signi cant ( P = 0.04), but a non-clinically relevant di erence (CDAI bene t of 18 points) compared with placebo (99) .…”

Section: Mild To Moderate Active Diseasementioning

confidence: 99%

Management of Crohn's Disease in Adults

2009

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Guidelines for clinical practice are intended to suggest preferable approaches to particular medical problems as established by interpretation and collation of scientifi cally valid research, derived from extensive review of published literature. When data that will withstand objective scrutiny are not available, a recommendation may be made based on a consensus of experts. Guidelines are intended to apply to the clinical situation for all physicians without regard to specialty. Guidelines are intended to be fl exible, not necessarily indicating the only acceptable approach, and should be distinguished from standards of care that are infl exible and rarely violated. Given the wide range of choices in any health-care problem, the physician should select the course best suited to the individual patient and the clinical situation presented. These guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee. Expert opinion is solicited from the outset for the document. The quality of evidence upon which a specifi c recommendation is based is as follows: Grade A: Homogeneous evidence from multiple well-designed randomized (therapeutic) or cohort (descriptive) controlled trials, each involving a number of participants to be of suffi cient statistical power. Grade B: Evidence from at least one large well-designed clinical trial with or without randomization, from cohort or case -control analytic studies, or well-designed meta-analysis. Grade C: Evidence based on clinical experience, descriptive studies, or reports of expert committees. The Committee reviews guidelines in depth, with participation from experienced clinicians and others in related fi elds. The fi nal recommendations are based on the data available at the time of the production of the document and may be updated with pertinent scientifi c developments at a later time.

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“…The potential for aminosalicylates to induce and/or maintain remission in Crohn's disease has been called into question 6 ,. 28 Aminosalicylates have been used in North America and Europe in the majority of patients with Crohn's disease. Studies from Olmstead County in Minnesota have observed that 30% of patients with Crohn's disease receive aminosalicylates during any given year, 29 and, in Copenhagen County, 80% of patients with Crohn's disease receive an aminosalicylate for at least one of the first 3 years of their disease 30 .…”

Section: Treatment Of Crohn's Diseasementioning

confidence: 99%

Aminosalicylates in inflammatory bowel disease

Hanauer

2004

Aliment Pharmacol Ther

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SUMMARYAminosalicylate therapy for ulcerative colitis remains a foundational strategy for the induction and maintenance of remission for mild to moderate disease. Although it seems clear that topical mesalazine (mesalamine) is the most efficacious approach to distal ulcerative colitis, recent trials with orally delivered azo conjugates suggest that there may be an advantage over pH-released mesalazine as a first-line approach to active disease. No such comparisons are available for azo products and the prolonged-release formulation, Pentasa. However, recent meta-analyses have demonstrated that, although there is little difference in systemic exposure between marketed products, luminal concentrations may vary. In maintenance therapy, aminosalicylates remain the standard approach after aminosalicylate-induced remission. A number of gaps remain in the evidence base with regard to the optimal dosing of oral mesalazine as a maintenance agent, whether oral mesalazine can maintain remissions after rectal mesalazine induction, and the dose-response and efficacy of aminosalicylates after steroid-or ciclosporininduced remissions. Although aminosalicylates have been advocated for several decades in Crohn's disease, a number of controversies have evolved since the original trials with sulfasalazine in active Crohn's disease. The original trials demonstrated benefits for sulfasalazine in colonic involvement, but controlled trial evidence for the role of sulfasalazine as maintenance therapy has not been as firmly established. In addition, although oral mesalazine has been demonstrated in controlled trials to be superior to placebo in mild to moderate disease, it is less efficacious than corticosteroids at inducing remissions. The maintenance benefits of mesalazine appear to be limited to patients Ôinduced into remissionÕ with mesalazine and in some post-operative settings.

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Aminosalicylates for active disease and in the maintenance of remission in Crohn's disease

Abstract: Eur J Surg 1998; 164: 903-909

Cited by 12 publications

References 13 publications

Systematic review: the effectiveness of budesonide therapy for Crohn's disease

Systematic review: the effectiveness of budesonide therapy for Crohn's disease

Management of Crohn's Disease in Adults

Aminosalicylates in inflammatory bowel disease

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