Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: A multicenter placebo-controlled study

Gendre, Jean–Pierre; Mary, Jean‐Yves; Florent, C; Modigliani, R; Colombel, Jean–Frédéric; Soulé, Jean–Claude; Galmiche, Jean–Paul; Lerebours, Éric; Descos, L; Viteau, J M; René, E; Metman, E.; Bories, P; Bremondy, A.; Bouvry, M; Lamouliatte, H; Gineston, J. L.

doi:10.1016/0016-5085(93)90411-5

Cited by 149 publications

(69 citation statements)

References 25 publications

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“…6, 10a, 10b, 12, 17 In Crohn's colitis, two studies showed a trend in favour of 5-ASA, 3,8 while ®ve studies did not give ®gures but stated that there was no signi®cant difference, 6,10,12,15,17 and one trial showed a trend against 5-ASA. 2 In Crohn's ileocolitis, 5-ASA was better than placebo in one trial, 2 and was not signi®cantly different from placebo in seven.…”

Section: Discussionmentioning

confidence: 99%

“…10 In the present study we made a more conservative estimate, and assumed an annual rate of clinical relapse of 35% in patients receiving placebo and of 15% in those receiving 5-ASA, with an ARR of 20%. Allowing for a 10% rate of exclusion in each group, about 110 patients per group were deemed necessary to achieve a 90% chance of demonstrating this difference with an alpha error of 0.05.…”

Section: Sample Size Calculation and Statistical Analysismentioning

confidence: 99%

“…In one of these studies, the bene®cial effect of 5-ASA was most signi®cant in patients with a short duration of remission before enrolment, suggesting that the early introduction of 5-ASA treatment after the achievement of remission might be a winning strategy in preventing relapse. 10 The aim of the present study was to test the ef®cacy of 5-ASA in preventing relapse of Crohn's disease in patients in whom 5-ASA treatment was introduced as soon as steroid-induced remission was achieved.…”

Section: Introductionmentioning

confidence: 99%

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Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Franchis

Omodei

Ranzi

et al. 1997

Aliment Pharmacol Ther

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Background Recent data indicate that 5‐aminosalicylic acid (5‐ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrolment. Aim To evaluate the efficacy of oral 5‐ASA treatment, started immediately after achieving steroid‐induced remission, in preventing clinical relapses of Crohn's disease. Methods Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5‐ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5‐ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. Results Final analysis included 117 patients (58 taking 5‐ASA and 59 taking placebo; follow‐up 9.2 ± 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5‐ASA patients and 31% and 52% in placebo patients, respectively (rate difference + 0.095; 95% CI = −0.085– + 0.274). Subgroups analysis showed that 5‐ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. Conclusions Contrary to previous results, in our study early introduction of treatment with oral 5‐ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.

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Section: Discussionmentioning

confidence: 99%

Section: Sample Size Calculation and Statistical Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Franchis

Omodei

Ranzi

et al. 1997

Aliment Pharmacol Ther

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“…This drug has been found to be superior to placebo for the treatment of active CD, as well as in maintaining its remission -something that has not been well demonstrated with sulfasalazine. 35 A lower dosage (2-3g/day vs 4g/day for CD) is effective in patients with active UC. In a still lower dosage (1-2g/day), mesalamine is as effective as sulfasalazine in maintaining remission of UC.…”

Section: -Aminosalicylic Acid Compoundsmentioning

confidence: 99%

Inflammatory Bowel Diseases: Current Therapeutic Approaches and Potential of Using Stem Cells

Srivastava¹

2017

JSRT

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Inflammatory bowel diseases (IBDs) are chronic and progressively deteriorating in nature without many promising curative treatments. Chronic inflammation of not well defined origins is considered to be the root cause of the problem which affects intestinal mucosa with or without transmural involvement. IBDs are divided in two main categories: Crohn's disease (CD) and ulcerative colitis (UC). While there is no long lasting cure for IBDs, current therapies can only reduce the causative inflammatory process with the hope to induce long-term remission. Treatment modalities for the IBDs are still evolving. The increased understanding of the underlying immunopathology has helped identify new targeted treatment options like immunosuppressive antibodies directed against signaling molecules. Use of stem cells, which are capable of modulating the immune system, can offer a long lasting relief to the patients suffering from the disease. The goal for stem cell-based therapy is to achieve long lasting cure, if not a permanent one. To achieve this, it would be desirable to obtain cell types, whether genetically modified or naturally occurring, having a high migratory ability in addition to homing ability into the afflicted parts of intestine. These cells should also have high in vivo survival potential, and then be able to regulate the immune reaction without provoking any response from the host's immune system and repair the injured tissue. Hematopoietic stem cells (HSC) and mesenchymal stromal cells (MSC) therapies are being investigated as a treatment for IBDs. MSC therapy is well tolerated and has minimal established side-effects compared to HSC therapy, which involves ablative chemotherapy. Several clinical studies using MSCs have been initiated and some early results suggest several inherent problems. In each study, optimization of MSC therapy appears to be the most urgent problem, which can be resolved only by scientifically unveiling the mechanisms of therapeutic action of stem cells. In this review, we summarize current therapies for IBDs and recent advances in the field of stem cell therapy, which offer promise to become the next generation treatment of choice.

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“…Mesalazine maintenance treatment is not superior to placebo (1,26) and cannot be recommended (Grade B).…”

Section: Mild Ileocecal CDmentioning

confidence: 99%

Consensus guidelines for the management of inflammatory bowel disease

2010

Arq. Gastroenterol.

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-This is the first Brazilian Consensus on inflammatory bowel disease, carried out by the Brazilian Study Group of Inflammatory Bowel Disease, and discusses the treatment of Crohn's disease and ulcerative colitis in acute and remission phases. The first part of the text, brings out a review on the main drugs used in the treatment of inflammatory bowel disease, as well as their mechanisms of action and cautions during their use. In the second part, the committee's opinions about the most recommended medical and surgical approaches for both diseases are presented on the basis of disease activity, location and behaviour status. The recommendations here presented were widely discussed in several scientific meetings with active participation of all members of the group and were highly based on scientific evidence covered by the literature. HEADINGS -Crohn disease. Colitis, ulcerative. Consensus.

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Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: A multicenter placebo-controlled study

Cited by 149 publications

References 25 publications

Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Inflammatory Bowel Diseases: Current Therapeutic Approaches and Potential of Using Stem Cells

Consensus guidelines for the management of inflammatory bowel disease

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