702 Efficacy and Safety of Delayed-Release Oral mesalamine At 4.8g/D (800mg Tablet) in the Treatment of Moderately Active Ulcerative Colitis: Results of the Ascend III Study

Sandborn, William J.; Reguła, Jarosław; Feagan, Brian G.; Belousova, Elena; Jojic, Njegica; Lukáš, Milan; Yacyshyn, Bruce; Krzeski, Piotr; Yeh, Chyon-Hwa; Hanauer, Stephen B.

doi:10.1016/s0016-5085(08)60464-3

Cited by 5 publications

(4 citation statements)

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“…Farup et al (46) compared the efficacy of an equal dose of a prolonged-release granule formulation of mesalazine (4 g/day, Pentasa sachet) divided into twice daily versus four times daily, with that of prolonged-release mesalazine tablets at two doses of 0.5 g four times daily in 227 patients with mild to moderately active UC. Granules were as effective as tablets, and twice- (37)(38)(39) daily dosing was as effective as more frequent dosing (46). Once again, the study was designed to confirm the noninferiority of the granule formulation to the tablet formulation.…”

Section: Once-daily 5-asa Granulesmentioning

confidence: 99%

Mesalazine in Inflammatory Bowel Disease: A Trendy Topic Once Again?

Iacucci

Silva

Ghosh

2009

Canadian Journal of Gastroenterology and Hepatology

109

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5-aminosalicylic acid (5-ASA) preparations (eg, mesalazine, mesalamine) are well-established preparations used in the management of inflammatory bowel disease. These drugs are most useful for the treatment of mild to moderate flares of ulcerative colitis and, especially, for maintenance of remission. Although most gastroenterologists are very familiar with these drugs, the interest in these drugs has undergone a resurgence, with new preparations offering convenience and high dosage, while preserving their customary safety. New dosage regimens are likely to become standard practice in the near future. There is also considerable interest in chemoprevention of colorectal cancer in the context of inflammatory bowel disease, and the role of long-term maintenance therapy with 5-ASAs in achieving such chemoprevention. A mechanism of action for such chemoprevention has been provided by the agonism of the peroxisome proliferator-activated receptor-gamma by 5-ASA, which unifies its efficacy as an anti-inflammatory and chemopreventive agent. In the future, even more effective agents based on 5-ASA are expected, based on more powerful agonism of peroxisome proliferator-activated receptor-gamma; 5-ASA preparations have become 'trendy' again.

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Section: Once-daily 5-asa Granulesmentioning

confidence: 99%

Mesalazine in Inflammatory Bowel Disease: A Trendy Topic Once Again?

Iacucci

Silva

Ghosh

2009

Canadian Journal of Gastroenterology and Hepatology

109

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“…A subgroup analysis showed that high‐dose 5‐ASA achieved patient symptom relief faster compared with the lower‐dose 5‐ASA. Data from the ASCEND studies also support the notion that more intensive therapy (i.e., higher doses) introduced at an earlier stage of moderately active disease may be beneficial; in the recent ASCEND III study a therapeutic advantage of 4.8 g/day was seen in patients with a clinical history of more difficult to treat disease, including previous use of rectal therapies, steroids, or immunomodulators 49. These findings should be interpreted in the context of the formulation tested and the study designs in relation to the definitions of “improvement” and “remission”; the same dose–efficacy relationship does not appear to hold true for other 5‐ASA formulations including ethyl‐cellulose coated mesalamine granules (Pentasa),27 lower dose pH coated mesalamine (Asacol),47 balsalazide,50 or olsalazine 51.…”

Section: Maintaining Remissionmentioning

confidence: 90%

Therapeutic strategies for the management of ulcerative colitis

Kamm

2009

Inflammatory Bowel Diseases

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Induction and maintenance of remission, mucosal healing, the avoidance of surgical intervention, and decreasing the likelihood of cancer developing are the primary therapeutic goals in ulcerative colitis (UC). For the traditional therapies, 5-aminosalicylic acid (including mesalamine), corticosteroids, and thiopurines (azathioprine and mercaptopurine), there are major changes evolving in terms of formulation, patterns of use, and appreciation of long-term benefits and toxicities. The calcineurin inhibitors cyclosporin and tacrolimus, and infliximab, have recently defined, well-established roles. Preliminary supportive evidence is emerging in relation to novel antiinflammatory molecules such as curcumin, manipulation of the bacterial flora, enhancement of the mucosal barrier, and direct epithelial restoration. For patients in whom the disease is resistant to standard simple therapies, strategies are required to integrate these developing and new therapies into clinical practice. This review aims to highlight the evidence supporting new patterns of use of existing therapies and new therapies, and to devise therapeutic pathways that incorporate these new treatments. We propose how treatment might be optimized to improve the outcome in patients with mild-to-moderately active UC, chronic active UC, resistant proctitis, and fulminant UC.

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“…The recent ASCEND III study confirmed the clinical benefit of delayed-release mesalazine 4.8 g ⁄ day in patients with moderately active UC; the therapeutic advantage of this higher dose compared with 2.4 g ⁄ day was most evident in patients with previous use of oral mesalazine and rectal therapies. 22…”

Section: Multi-matrix (Mmx) Mesalazine (12 G Tablet)mentioning

confidence: 99%

Review article: new drug formulations, chemical entities and therapeutic approaches for the management of ulcerative colitis

Kamm

2008

Aliment Pharmacol Ther

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Summary Background Treatment options for ulcerative colitis (UC) are expanding with the development of novel drug formulations and dosing regimens and new chemical entities. Although the goals of medical therapy for UC remain unchanged, that is to induce and to maintain remission, focus has also centred on improving patient compliance, modifying the natural course of disease and healing the mucosa. Aim To examine novel formulations, new chemical entities and novel therapeutic approaches to the management of UC. Methods Searches for all studies related to UC treatment in Medline and abstracts from major national and international meetings published in the last 10 years. Results 5‐Aminosalicylic acids (5‐ASA) remain the standard first‐line treatment for patients with mild to moderately active UC. New formulations with altered delivery, and new dosing regimens have demonstrated possible improvements in efficacy compared with historically available preparations and dosing patterns. Once‐daily dosing, micropellet formulations, and high‐dose tablets offer enhanced efficacy and improved compliance. 5‐ASA is now recognized as a ligand for peroxisome proliferator‐activated receptor‐γ (PPAR‐γ) and it has a role as a chemo‐preventive agent in long‐standing UC. New colonic release corticosteroid formulations help to limit systemic toxicity; turmeric, tacrolimus and infliximab have shown promising results. New anti‐inflammatory targeted therapies include an anti‐CD3 antibody, selective integrin blockers, anti‐IL‐2 antibody and PPAR‐γ agonists. Conclusion The evolution of novel oral 5‐ASA formulations and dosage regimens, and recent development of new molecules have expanded the therapeutic armamentarium of UC.

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702 Efficacy and Safety of Delayed-Release Oral mesalamine At 4.8g/D (800mg Tablet) in the Treatment of Moderately Active Ulcerative Colitis: Results of the Ascend III Study

Cited by 5 publications

References 0 publications

Mesalazine in Inflammatory Bowel Disease: A Trendy Topic Once Again?

Mesalazine in Inflammatory Bowel Disease: A Trendy Topic Once Again?

Therapeutic strategies for the management of ulcerative colitis

Review article: new drug formulations, chemical entities and therapeutic approaches for the management of ulcerative colitis

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