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Increasing the doses of oral mesalazine formulations does not result in higher remission rates, although increasing the doses of some formulations has been effective in increasing symptomatic improvement and/or response to treatment.
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In search of new therapies in IBD, the introduction of 4-aminosalicylic acid (4-ASA) has been proposed based on the longstanding, positive clinical experience in tuberculosis, the expected similar modes of action due to the close structural analogy to 5-aminosalicylic acid (5-ASA), an established therapy in IBD, and its inexpensiveness. To better understand the mechanisms of action of aminosalicylates, the intestinal inflammatory response and to develop new, more effective and cost saving drugs it is important to compare 4-ASA with 5-ASA with respect to their pharmacology, mechanisms of action and clinical efficacy. The inhibition of the upregulation of the initial local immune response, the inhibition of the production of inflammatory mediators, e.g. leukotrienes and the direct scavenging of toxic oxygen metabolites are important common antiinflammatory mechanisms. As the clinical experience with 4-ASA is promising, but still limited, 4-ASA currently cannot yet be recommended outside clinical trials. As the costs of 4-ASA are significantly lower compared to 5-ASA, 4-ASA may replace 5-ASA in the near future provided further trials will confirm the therapeutic and pharmacologic equivalency.
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Combination therapy with ciprofloxacin and tinidazole was generally well tolerated and was effective in treating patients with chronic refractory pouchitis.
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Two randomised controlled trials (RCT) found the role of antibiotics in managing acute diverticulitis to be questionable, particularly in patients with no complicating comorbidities. One RCT found mesalazine to be effective in preventing acute diverticulitis in patients with symptomatic uncomplicated diverticular disease. The role of rifaximin or mesalazine in preventing diverticulitis recurrence, based on the results of 1 and 4 RCTs, respectively, remains unclear. RCTs found rifaximin and mesalazine to be effective in treating symptomatic uncomplicated diverticular disease. The use of probiotics in diverticular disease and in preventing acute diverticulitis occurrence/recurrence appears promising but unconclusive. Finally, the role of fibre in treating diverticulosis remains unclear.
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Objectives and importance: Mesalazine is a widely used and generally safe drug for the treatment of chronic inflammatory bowel diseases. Neutropenia rarely complicates this treatment and very few cases have been reported in the literature.
A pH-sensitive, polymer-coated oral preparation of mesalamine (5-aminosalicylic acid) was used at 1.6 and 2.4 g/d for 6 weeks.
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The role of thiopurines in altering the risk of colectomy in ulcerative colitis (UC) remains unclear.
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Of 36 patients, 25 responded to i.v. CSA and were switched to p.o. CSA. Of the 25, 13 required colectomy by 9 months. The other 12 patients had a sustained response to CSA and avoided colectomy at 9 months. Overall, 24 of 36 patients treated with CSA required colectomy by 9 months. A high percentage of band neutrophils (bands) on admission was found to be a significant predictor of response to CSA.
tP-selectin was measured by immunoassay in seventeen IBD patients and twelve healthy controls.
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The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).
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Laparoscopic segmental small-bowel resection with end-to-end anastomosis. Postsurgical treatment with Pentasa 4 g a day.
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Between January 2004 and August 2005, patients with UC, in whom remission of the condition had just been induced, were randomly assigned to either: the weekend 5-ASA enema group (n=11), who received 1 g 5-ASA enemas twice a week on Saturday and Sunday plus oral 5-ASA 3 g/day for 7 days, or to the daily oral 5-ASA use only group (n=13), who received only oral 5-ASA 3 g/day for 7 days. The primary endpoint of the study was defined as the incidence of relapse. The study was stopped after 24 patients had been enrolled because an interim analysis showed a significant benefit of the weekend 5-ASA enema group.
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We evaluated the efficacy of mesalamine (Asacol) in reducing gastrointestinal symptoms after an acute attack of diverticulitis.
Asacol, a medication that delivers delayed release 5-aminosalicylic acid (5-ASA), is a useful therapeutic agent for inflammatory bowel disease (IBD), but the relationship between its pharmacological actions and intestinal concentrations has not been studied in detail. Therefore, our aim was to assess 5-ASA's pharmacological actions as a function of its concentration at its target site. We first evaluated 5-ASA's release profiles in vitro by the paddle method and found that Asacol starts to release 5-ASA at pH ≥ 7. Orally administered Asacol pharmacokinetic parameters were evaluated in dogs. Asacol's T(max) was much longer than that of the time-dependent release 5-ASA formulation. We also determined 5-ASA's distribution in the intestinal mucosa and found that it is effectively delivered there by Asacol. These results indicated that Asacol released 5-ASA in a pH-dependent manner, resulting in efficient delivery to the large intestine. We also compared the mucosal 5-ASA concentrations with the IC(50) values for scavenging free radicals or suppressing LTB(4) production. The 5-ASA concentration in the large intestine was higher than IC(50) values necessary to suppress inflammatory processes. We also report the release characteristics of Asacol and the targeted delivery of 5-ASA to affected sites in IBD patients.
To investigate whether microproteinuria in patients with inflammatory bowel disease (IBD) is associated with the disease activity or the treatment with 5-aminosalicylic acid (5-ASA).
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Intestinal resection in the natural history of Crohn's disease is a forced step. Unfortunately surgery is not curative as disease inexorably recurs. The frequency of recurrence varies according to the definitions adopted, being high when endoscopical criteria are used (70-90% at one year). Among risk factors, the most convincing is a smoking habit. The pathogenesis of recurrence is still unknown. Particular attention was paid to colo-ileal reflux which occurs after the resection of the ileocecal valve. The diagnosis should always be based on morphological criteria (endoscopy or radiology). In fact symptoms occur late and are often uncharacteristic. A particular problem in the management of patients with Crohn's disease is the prevention of post-operative recurrence. Recent randomized, controlled trials of which the first has been published by the authors of this article, demonstrated that the administration of 5-ASA early after resection may prevent, delay or attenuate such recurrences. Cessation of smoking also plays a central role in prevention. The final message is that in active Crohn's disease surgery should not be excessively delayed. Early resection followed by prophylactic treatment seems to improve the quality of life in patients with more severe Crohn's disease.
High-dose (4.0 g/day) mesalazine is typically used for induction therapy, but its efficacy as maintenance therapy remains to be determined. We conducted a multicenter retrospective study to investigate the efficacy of continuous treatment with 4.0 g/day of mesalazine.
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A statistically significant difference in the level of antibodies against PtpA was measured in untreated CD patients versus healthy controls, but variation in the antibody levels was observed when patients were subjected to different treatment regimens. UC patients showed no differences in the levels of antibodies against PtpA when compared to healthy controls.
There is uncertainty about the efficacy and safety of treatment for hepatitis C virus (HCV) infection in patients with inflammatory bowel disease (IBD). IBD can become exacerbated during treatment with interferon (IFN), and serious adverse events, such as pancytopenia or hepatotoxicity, can be compounded by drug interactions. We investigated the risk of exacerbation of IBD during HCV therapy and the rate of adverse effects of concomitant therapy for HCV and IBD. We also evaluated the efficacy of HCV treatment in the IBD population.
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Mucosally adherent E. coli are found in inflammatory bowel disease (IBD) and colon cancer. They promote release of the proinflammatory cytokine interleukin-8 (IL-8). We explored mechanisms for this release and its inhibition by drugs.
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To examine the absorption and distribution of 5-aminosalicylic acid (5-ASA) in rat colon after oral administration of its chitosan capsule.
Parallel to an increasing use of thiopurines and TNF-α blockers in IBD over time, a persistent significant decrease in surgery rates was observed along with a significant decrease in use of 5-ASA and corticosteroids. However, no convincing surgery-sparing effect of newer medications was found.
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5-Aminosalicylate, which is considered to be the active moiety of sulfasalazine, is one of the most widely used agents for treatment of inflammatory bowel disease. However, its mechanism of action is unclear. In this report, we provide evidence that the phospholipase D pathway is a target for this drug in macrophages. Activation of phospholipase D leads to the generation of important second messengers such as phosphatidic acid, lysophosphatidic acid and diacylglycerol, all of which can regulate cellular responses involved in inflammation. Murine peritoneal macrophages were labeled with [(3)H]myristate, incubated with various drugs, agonists, or inhibitors, and phospholipase D activity was assayed. 5-Aminosalicylate or sulfasalazine stimulated phospholipase D in a time- and concentration-dependent manner. Chelation of extracellular Ca(2+) inhibited phospholipase D activation by either of these drugs whereas pretreatment of macrophages with the tyrosine kinase inhibitor genistein had no effect. Downregulation of protein kinase C by prolonged incubation with phorbol ester completely blocked the activation of phospholipase D. Pertussis toxin decreased the activation of phospholipase D. The levels of inositol 1,4,5-trisphosphate increased by 260% after treatment of macrophages with 5-aminosalicylate. A phosphoinositide-specific phospholipase C inhibitor U73122 blocked phospholipase D activation completely. Interestingly, long-term preincubation of the macrophages with a relatively low concentration of 5-aminosalicylate that did not stimulate phospholipase D activity by itself, potentiated the effect of phorbol ester-induced activation of phospholipase D. Taken together, these results show that 5-aminosalicylate activates phospholipase D via a pathway involving inositol 1,4,5-trisphosphate generation, calcium fluxes, and Gi/Go. Although the mechanisms by which phospholipase D activation by 5-aminosalicylate or sulfasalazine might attenuate inflammatory responses in the intestine remain to be defined, these results highlight a novel potential mechanism of action for these drugs.
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The ileal pouch anal anastomosis (IPAA) procedure has become the preferred surgical option for most patients with ulcerative colitis who require surgical removal of the colorectum. The vast majority of patients with this new anatomy will either not develop pouchitis or develop a few discrete episodes of acute pouchitis. However approximately one fourth of patients will develop recurrent pouchitis, with 5% being categorized as chronic pouchitis requiring maintenance therapy or, on rare occasion, pouch excision. Factors that are associated with an increased risk of pouchitis include primary sclerosing cholangitis, extraintestinal manifestations, and nonsmokers. Controversy surrounds other risk factors such as extent of colitis, backwash ileitis, preoperative pANCA levels, and carrying a specific allele for IL-1 receptor antagonist. The etiology of pouchitis is unknown, but theories range from genetic susceptibility, bacterial overgrowth, ischemia, and fecal stasis, to a recurrence of ulcerative colitis in the pouch, a missed diagnosis of Crohn's disease, or possibly a novel third form of inflammatory bowel disease. Some patients with symptoms of pouchitis will not have inflammation of the pouch, but rather, irritable pouch syndrome. Thus, endoscopic investigation with biopsy is important for declaring whether a patient has pouchitis. Indeed, the more commonly used scores, such as the pouch disease activity index, incorporate both endoscopic and histologic criteria. Not surprisingly, treatment options for patients with pouchitis resemble that of regular inflammatory bowel disease, although there have only been a few controlled trials. Antibiotics are the mainstay of therapy, with metronidazole and ciprofloxacin demonstrating benefit in controlled trials. Probiotics are effective for maintaining remission of pouchitis. Mesalamine, corticosteroids, and immunomodulators have been used with some success. Occasionally, patients with well-documented ulcerative colitis as the indication for IPAA will develop what appears to be Crohn's disease of the pouch, on the basis of granulomatous inflammation, pre-pouch ileitis, or fistulae. The treatment is similar to Crohn's disease, including the use of infliximab. Dysplasia within the pouch mucosa itself is quite rare. Reports of dysplasia occurring in patients with IPAA are usually due to neoplastic change within the residual cuff of rectal or transition zone mucosa just below the pouch, rather than in the ileal mucosa of the pouch. With further elucidation of the genetic basis for inflammatory bowel disease, we should be able to more accurately classify patients with ulcerative colitis and Crohn's disease genotypically. Hopefully, this will also bring more clarity to the heterogeneous population of patients with pouchitis and allow for more focused therapeutic strategies.
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In recent years new standards for the treatment of ulcerative colitis have evolved. This review updates evidence based therapy for the various clinical situations as well as some novel approaches. The literature search was based on Medline, Cochrane database (CD-ROM) and handsearch of relevant papers including quoted literature. There is clear-cut evidence-based support for the use of local 5-aminosalicylates in mild/moderate distal and oral 5-aminosalicylates in extensive ulcerative colitis. The administration of corticosteroids is definitely indicated in severe disease. Fulminant attacks are treated by intravenous cyclosporine or colectomy. In chronic active disease azathioprine is probably helpful. Relapse prevention again is a domain of 5-aminosalicylates or, as a novel development, E. coli Nissle. The various meta-analyses as well as the controlled trials performed in the various clinical situations typical for the manifestations of ulcerative colitis form a solid base of evidence to guide individual treatment decisions.
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Sulphasalazine is composed of sulphapyridine and mesalazine (5-aminosalicylic acid, 5-ASA or mesalazine) joined by an azo bond. Sulphasalazine has been used clinically for 40 years but less than 10 years ago it was recognized that the active moiety is 5-ASA. Sulphapyridine appears to act only as a carrier molecule to deliver mesalazine to the bowel, yet it is the sulphapyridine which appears to be responsible for many of the adverse effects observed with sulphasalazine. Normally, mesalazine is rapidly absorbed from the upper gastrointestinal tract. Since the action of mesalazine is thought to be locally at the site of disease in the intestine, the 5-ASA must be 'protected' to ensure its release in the terminal ileum and colon, the site of bowel inflammation in patients with Crohn's disease or ulcerative colitis. Recent clinical studies have confirmed the efficacy of topical (suppositories and enemas) therapy for ulcerative proctitis and left-sided colitis; oral mesalazine has been proven to be useful for the treatment of acute ulcerative colitis and for the maintenance of remission. There is preliminary evidence for the clinical usefulness of mesalazine in acute Crohn's disease as well as for the maintenance of remission.
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ClinicalTrials.gov identifier: NCT01257399.
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We investigated the safety and efficacy of sodium hyaluronate enema (IBD98E) in distal active ulcerative colitis, in a prospective, uncontrolled, open-label pilot trial. Subjects with active distal ulcerative colitis (UCDAI ≥ 4 and sigmoidoscopy score ≥ 1) received IBD98E 60 mL enema once a day. Primary endpoints were safety and clinical response rate at Day 28. Secondary endpoints included clinical remission, endoscopic remission, and tolerability of IBD98E. Paired Student's t-test was performed to assess statistically significant differences in subjects between baseline and Day 28.
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Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%).
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This was a 3-year, two-cohort, multi-centre study: one cohort was in stable remission (52 patients) and the other was newly in remission (76 patients) from ulcerative colitis. Two 750-mg balsalazide capsules were given twice daily for maintenance, increased by 750-mg increments to a maximum of 6 g for up to 7 days depending on symptom severity. Clinical assessments were made every 12-14 weeks; laboratory assessments were made every 6 months.