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Therapy with mesalamine significantly reduced the risk of symptomatic relapse (pooled risk difference, -6.3%; 95% confidence interval, -10.4% to -2.1%). The pooled risk difference was significant in the postsurgical setting (-13.1%; 95% confidence interval, -21.8% to -4.5%) but not in the medical setting (-4.7%; 95% confidence interval, -9.6% to 2.8%). Multivariate model predicts that the probability of symptomatic relapse significantly decreases with mesalamine treatment, by increasing proportion of patients with ileal disease, with prolonged disease duration, and with surgically induced remission.
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We identified the natural phenols, caffeic acid and resveratrol, the NSAID, flufenamic acid, and the polyphenol 13b as novel KCa3.1 inhibitors. The high potency of 13b with pan-activity on KCa3.1/KCa2 channels makes 13b a new pharmacological tool to manipulate inflammation and cancer growth through KCa3.1/KCa2 blockade and a promising template for new drug design.
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To investigate the possibility of local treatment of colitis with the adhesive antioxidant enzymes catalase and superoxide dismutase (SOD).
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Ulcerative colitis (UC) substantially reduces patients' health-related quality of life (HRQoL). The current study examined the burden of disease and the impact of daily multimatrix (MMX®) mesalamine treatment on HRQoL for patients with active or quiescent mild-to-moderate UC.
Well-designed pharmacoepidemiology studies address several limitations of postmarketing spontaneous reports in regard to signal evaluation. This study evaluated a signal of disproportionate reporting of acute pancreatitis cases observed in patients with ulcerative colitis (UC) treated with MMX Multi Matrix System® (MMX®) mesalazine and demonstrated how inherent limitations of postmarketing reports were overcome.
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We recommend periodic ocular fundus examination for patients undergoing long-term therapy with mesalazine, especially if decreased vision, headaches, or neck stiffness are present, to avoid potentially severe complications of intracranial hypertension
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Intrarectal pretreatment with NPC 15669 results in a significant reduction of all measured indices of inflammation. The median effective dose (ED50) of NPC 15669 for inhibition of MPO accumulation and vascular permeability is 13.2 mg/kg and 31 mg/kg, respectively. The active moiety of sulfasalazine, 5-aminosalicylic acid (5-ASA), the antioxidant/5-lipoxygenase inhibitor, nordihydroguaiaretic acid (NDGA) and the corticosteroids dexamethasone and hydrocortisone, yielded ED50 values (MPO accumulation) of 68 mg/kg, 95 mg/kg, 0.7 mg/kg, and 13 mg/kg, respectively. When formulated suspensions of NPC 15669, 5-ASA, or dexamethasone were used, potency was increased 10-40-fold. Furthermore, NPC 15669 (10 mg/kg) administered 7 hours after acetic acid and evaluated 24 hours after acetic acid administration significantly attenuated neutrophil influx (70% inhibition of MPO accumulation), whereas 5-ASA (100 mg/kg) displayed no therapeutic effects.
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Drug plasma concentrations and urinary and fecal excretions after a single dose (400-4800 mg) and multiple doses (3600 mg/day for 7 days) were investigated.
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The study was a double-blind, randomized, multi-centre, prospective, controlled clinical trial. Two hundred and six patients, submitted to first or second intestinal resection for Crohn's disease limited to the terminal ileum, with or without involvement of the caecum/ascending colon, were enrolled. Of these, 101 were randomly allocated to receive 4.0 g/day of mesalazine (Asacol, Giuliani SpA, Milan, Italy) and 105 to receive 2.4 g/day, starting 2 weeks after surgery. The primary outcome was endoscopic recurrence, at 12 months after surgery. Three different degrees of endoscopic recurrence were evaluated (endoscopic scores: > 0, > 1 and > 2). The secondary outcome was clinical recurrence, defined as a Crohn's disease activity index of more than 150 points or an increase in the Crohn's disease activity index of 100 points or more. For statistical analysis, chi-square, Wilcoxon and Cox regression model tests were used, when appropriate.
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New acrylic type polymeric systems having degradable ester or amide bonds linked to the bioactive agent 5-amino salicylic acid (5-ASA), were prepared and evaluated as materials for colon-specific drug delivery. Methacryloyloxyethyl 5-amino salicylate (MOES), and N-methacryloylaminoethyl 5-amino salicylamide (MAES) were prepared as the polymerizable derivatives of 5-ASA using activated ester methodology. The drug-containing monomers were free radically copolymerized with methacrylic acid or hydroxyethyl methacrylate, utilizing azobisisobutyronitrile as initiator. The polymer bearing 5-ASA units as side substituents of the acrylic backbone were obtained in the form of poly pendent esters or poly pendent amides. The drug release studies were performed by hydrolysis in buffered solutions (pH 1, 7.2, 8.5), or simulated intestinal fluid containing pancreatin to measure the chemical degradation expected to occur in the intestinal tract. The release profiles indicated that the hydrolytic behavior of polymers strongly depends on their degree of swelling, type of comonomer, and the nature of hydrolyzable bond. Implication of the results for use of these polymers for colon targeting are discussed.
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The risk of developing colorectal cancer is increased in patients with inflammatory bowel disease. Surveillance colonoscopy has not been shown to prolong survival and rates of interval cancer are reported to be high. Continuing colonic inflammation has been shown to be important in the development of colorectal cancer and therefore anti-inflammatory agents such as the 5-aminosalicylates and immunomodulators have been considered as potential chemopreventive agents. This review focuses on various chemopreventive agents that have been clearly shown to reduce the risk of colorectal adenoma and cancer in the patients with inflammatory bowel disease.
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Therapeutic efficacy of 5-aminosalicylic acid (5-ASA) preparations is reviewed. In the acute treatment of Crohn's disease, Pentasa and Salofalk seem to be more effective than placebo. When it is given in an equimolar 5-ASA regimen, Salofalk appears to be at least as effective as sulfasalazine (SAS) in the treatment of both Crohn's disease and ulcerative colitis. Asacol and SAS are equally effective in maintenance therapy of ulcerative colitis. Dipentum was more efficient than placebo. There was only a low incidence of side effects from oral 5-ASA preparations, but larger-scale trials may be needed for a more accurate profile of adverse reactions.
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Maintenance therapy with mesalazine or sulfasalazine reduces the risk of clinical disease relapse in Crohn's disease after 1 yr. This benefit is seen primarily in the more recent studies that have used mesalazine as the therapeutic agent.
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We report 3 cases of the occurrence of adverse events in patients with Crohn's disease who were given aminosalicylic acids. The first case involved a 43-year-old woman who developed interstitial pneumonitis requiring intubation after switching from mesalazine to sulphasalazine. Thereafter, mesalazine was used without complications. When sulphasalazine was reintroduced, the symptoms recurred. A second patient was a 56-year-old man who experienced worsening of abdominal symptoms after commencing mesalazine for an exacerbation of Crohn's disease; these symptoms improved following discontinuation of mesalazine. A third patient, a 23-year-old woman, had been treated with mesalazine for Crohn's disease for 6 months when budesonide was added because of insufficient response. After 3 weeks she was hospitalized for acute pancreatitis, which resolved after both medications were discontinued. Pancreatitis due to budesonide has not been previously described, but mesalazine is known to cause pancreatitis even after uncomplicated long-term use. Although effective in ulcerative colitis, aminosalicylic acid is not an effective treatment for Crohn's disease in general. Although adverse effects are rare, physicians should be aware of them and avoid unnecessary use.
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Acute bloody diarrhoea may be commonly encountered in the acute medical unit. Among young patients, the main differential diagnoses are acute infectious colitis, and first presentation of inflammatory bowel disease (IBD). A combination of clinical, laboratory, radiological, endoscopic and histological investigations are required to make the diagnosis. If inflammatory bowel disease is suspected, then the patient should be admitted to a specialist gastroenterology ward and receive input from the surgical team, IBD nurses and specialist stoma nurses. Intravenous steroid therapy for acute severe disease should be started before stool cultures are back unless there is a strong clinical suspicion of amoebiasis. All patients require thromboprophylaxis and close attention paid to fluid balance and nutritional requirements. Daily clinical review is required. The Travis criteria may be employed at day 3 to assess the likelihood of requiring surgery and plans for rescue therapy, medical or surgical should be made between day 3-7 if the patient is not responding adequately to initial medical therapy.
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The second scientific workshop of the European Crohn's and Colitis Organization (ECCO) focused on the relevance of intestinal healing for the disease course of inflammatory bowel disease (IBD). The objective was to better understand basic mechanisms, markers for disease prediction, detection and monitoring of intestinal healing, impact of intestinal healing on the disease course of IBD as well as therapeutic strategies. The results of this workshop are presented in four separate manuscripts. This section describes basic mechanisms of intestinal healing, identifies open questions in the field and provides a framework for future studies.
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In all, 354 patients were evaluable for safety and per-protocol analysis. The new regimen demonstrated noninferiority: The percentage of patients with remission was 87.9% for the once-daily 1 g mesalamine suppository and 90.7% for the thrice-daily 0.5 g mesalamine suppository. Each regimen resulted in prompt cessation of clinical symptoms (e.g., median time to ≤3 stools per day (all without blood): 5 days in the 1 g mesalamine once-daily and 7 days in the 0.5 g mesalamine thrice-daily group). Patients preferred applying suppositories once a day.
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A 14-year-old girl with ulcerative colitis was admitted for a left pneumothorax. She was given corticoidsteroids and enemas of 5 aminosalicylic acid. The pneumothorax was not controlled by pleural drainage and a pleural irritation was performed under thoracoscopy. Recurrence of pneumothorax led to surgical pleurectomy. The following day, a right pneumothorax occurred, also requiring pleurectomy. The pulmonary biopsies showed constrictive bronchiolitis. A restrictive syndrome was confirmed by functional pulmonary examinations. Total colectomy was performed nine months later for the ulcerative colitis.
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To compare the efficacy in delivery of active 5-ASA to the colon and the systemic load as the basis for potential long-term toxicity during treatment with olsalazine or mesalazine in patients with ulcerative colitis in remission.
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Of 1,490 patients in our registry, 394 have UC (mean age at diagnosis 11.3±3.7 years); 197 (50%) received thiopurine (49% ≤3 months from diagnosis). Also, 84% were receiving CSs and 60% 5-aminosalicylates at thiopurine start. Of the 197 patients, there was insufficient follow-up (41), previous or concomitant use of infliximab (16), or calcineurin inhibitor (7), leaving 133 patients evaluable at 1 year. Of these, 65 (49%) had CS-free inactive UC without rescue therapy. CS-free inactive disease at 1 year after initiating thiopurine was not affected by starting thiopurine ≤3 months vs. >3 months from diagnosis, gender, age, or concomitant treatment with 5-aminosalicylates. Kaplan-Meier analysis showed that the likelihood of remaining free of rescue therapy in the thiopurine-treated patients was 73% at 1 year.
Ibuprofen (IB) and mesalamine (MES) are commonly used NSAIDs whereas benzimidazole (BZ) and 2-aminobenzimidazole (ABZ) are important pharmacophore for immunomodulatory activities. In the present study, IB and MES were coupled with variedly substituted BZ or ABZ nucleus to synthesize IB-BZ (2a-2e), IB-ABZ (3a-3e), MES-BZ (4a-4e) and MES-ABZ (5a-5e) chimeric conjugates as novel compounds that could elicit both anti-inflammatory and immunomodulatory activities. Each compound retained the anti-inflammatory activity of the parent NSAID. The BZ conjugates (2 and 4) were found immunostimulatory whereas the ABZ conjugates (3 and 5) were immunosuppressive. Each compound also exhibited good antioxidant activity, which is attributed to the electron rich BZ and ABZ nuclei. Compound 2a, 2e, 3a, 3e and 5b exhibited the most significant anti-inflammatory and immunomodulatory activities. Hence, these were evaluated for in vivo acute gastric ulcerogenicity. The compounds were safe to gastric mucosa, probably due to masking of the free -COOH group of IB and MES, and/or to the BZ nucleus itself. A benzoyl group at 5-position of BZ and ABZ incurred maximum immunostimulatory activity. In contrast, a -NO2 group incurred the maximum immunosuppressive action. Docking analysis revealed the compounds to be more selective towards COX-2 enzyme, which support the gastroprotective activity. These results suggest that the compounds can be taken as lead for development of new drugs for the treatment of immune related inflammatory disorders, such as cancer and rheumatoid arthritis.
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380 patients were evaluable for efficacy and safety by intention-to-treat (ITT); 345 for per protocol (PP) analysis. In the ITT population, 79.1% in the OD group (n = 191) and 75.7% in the TID group (n = 189) achieved clinical remission (p<0.0001 for non-inferiority). Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group (86%; n = 97) versus the TID group (73%; n = 100; p = 0.0298). About 70% of patients in both treatment groups achieved endoscopic remission, and 35% in the OD group and 41% in the TID group achieved histological remission. About 80% of all patients preferred OD dosing. Similar numbers of adverse events occurred in 55 patients (28.8%) in the OD group and in 61 patients (32.3%) in the TID group, indicating that the two dosing regimens were equally safe and well tolerated.
Any patient presenting with chest pain, shortness of breath, or fever within 28 days after initiating a 5-ASA-containing drug should be considered as exhibiting drug-induced inflammation. The 5-ASA-containing drug should be stopped immediately until other causes can be proven (or excluded); if no other cause is discovered, the 5-ASA should not be restarted.
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The aim was to evaluate the effect of 5-aminosalicylic acid on myocardial capillary permeability for small hydrophilic molecules after ischaemia and reperfusion.
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The rates of remission at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 17.9%, 13.2%, and 12.1%, respectively, compared with 7.4% for placebo (P = .0143, P = .1393, and P = .2200). The rates of clinical improvement at week 8 among patients given 9 mg or 6 mg budesonide MMX or mesalamine were 33.3%, 30.6%, and 33.9%, respectively, compared with 24.8% for placebo (P = .1420, P = .3146, and P = .1189). The rates of endoscopic improvement at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 41.5%, 35.5%, and 33.1%, respectively, compared with 33.1% for placebo. The rates of symptom resolution at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 28.5%, 28.9%, and 25.0%, respectively, compared with 16.5% for placebo (P = .0258, P = .0214, and P = .1025). Adverse events occurred at similar frequencies among groups.
The medical records of patients with CD who underwent bowel resection during a 4-year period were reviewed. Only patients who received AZA or 5-ASA as prophylaxis for recurrence were included.
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Sulfapyridine (SP) and 5-aminosalicylic acid (5-ASA) are the two primary metabolites of the anti-inflammatory drug salicylazosulfapyridine (SASP). These two metabolites were studied for induction of chromosomal damage in mammalian cells, in vitro and in vivo, in an attempt to understand better the genetic effects produced by SASP in humans and laboratory mice. To this end, SP and 5-ASA were tested for induction of sister-chromatid exchanges (SCE) and chromosomal aberrations (Abs) in Chinese hamster ovary (CHO) cells in vitro. In addition, they were tested in vivo for induction of micronuclei (MN) in mouse bone marrow polychromatic erythrocytes (PCE). SP gave positive results in the in vitro SCE test and the in vivo MN test, and negative results in the in vitro Abs test. 5-ASA was negative in all three tests. These results indicate that it is the SP metabolite of SASP that is necessary for the induction of chromosomal damage reported to occur in humans and mice after treatment with SASP.
We report two cases of systemic lupus erythematosus (SLE) complicated with colonic ulcerations. One patient was successfully cured by steroid therapy, while the other did not respond to steroid but oral mesalazine was effective. Systemic lupus erythematosus is frequently accompanied by gastrointestinal symptoms, but colonic lesions are quite rare, and the regular treatment is not fixed yet. The high-dose steroidal regimen may be effective for microvasculitis, although it may increase the risk of perforated ulcer of the intestinal tract, which is a life-threatening complication. Further analysis of its outcomes, and establishment of the regular guideline for its treatment are expected.
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Evaluation of: Kruis W, Meier E, Schumacher M, Mickisch O, Greinwald R, Mueller R; German SAG-20 Study Group. Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon - a placebo-controlled study. Aliment. Pharmacol. Ther. 37(7), 680-690 (2013). Although diverticular disease (DD) is one of the commonest diseases in the western world, robust evidences about its treatment are lack so far. A recent, placebo-controlled study found mesalazine effective in obtaining pain relief in patients suffering from DD. A brief comment is provided herein in order to assess the rationale of this drug in treating DD.
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To determine the prevalence of Helicobacter pylori in patients with inflammatory bowel disease (IBD) and compare this to the prevalence in a control population with non-organic bowel symptoms, and to investigate the effect of sulphasalazine and other 5-aminosalicylic acid (5-ASA) drugs on the prevalence of H. pylori in IBD patients.