BENEFICIAL EFFECT OF ORAL MESALAZINE POWDER ADMINISTRATION ON GASTRIC INVOLVEMENT OF BEHÇET's DISEASE
Reiko KunisakiTakako KawaiMakiko ShiozawaFumio SuzakiMasaru NaitohShizuo TominagaMasayuki FujinoMasanori Tanaka
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Behçet's disease (BD) is a multisystem immune‐mediated inflammatory disorder that involves the gastrointestinal tract. Although intestinal BD chiefly affects the ileocecum and colon, it may involve the entire alimentary tract. Upper gastrointestinal involvements of BD are not common, and its treatment has been rarely reported. Mesalazine is known to be an effective anti‐inflammatory agent for treatment of distal intestinal lesions of inflammatory bowel disease by its delayed drug release system. Here we show a case of chronic active, steroid‐dependent BD involving the upper gastrointestinal tract who was treated with ground mesalazine powder. Endoscopy performed 8 weeks after the treatment showed marked improvement of the gastric ulcers. This is the first report of intestinal BD treated with oral administration of mesalazine powder, and our results suggest that it may be a beneficial and effective new therapy for the upper gastrointestinal lesion of BD.Keywords:
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This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission.In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding.The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, -3.9% to 17.6%). The noninferiority margin of -10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety.A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.
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Objective: In order to learn more side-effects of Mesalazine,one case that Mesalazine indced fever in a patient with Crohn disease(CD) was investigated.Methods:Many clinical case-report about side-effects of Mesalazine were observed by index system.Results:Patient's temperature returned to normal after Mesalazine disused for two days.Conclusion:It's necessary to pay more attention on rare side-effects of Mesalazine,fever,which was reported less in clinic.
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Objective To evaluate the clinical efficacy of bifico combined with mesalazine in patients with mild to moderate ulcerative colitis(UC),and to explore its mechanism.Methods Sixty patients with mild to moderate active UC were randomized to combination group(n=30) and mesalazine group(n=30).The patients were treated by bifico and mesalazine in combination group and only by mesalazine in mesalazine group for 8 weeks.The changes of clinical symptoms and disease activity under endoscopy were evaluated before and after the treatment.The expression of NF-κB in colonic mucosa was also detected by immunohistochemical staining.Results The clinical symptoms and disease activity under endoscopy were improved more in combination group than in mesalazine group(P0.05).The expression of NF-κB significantly lower in combination group than that in mesalazine group(P0.05).Conclusion The combination of bifico and mesalazine is more effective than mesalazine alone in treatment of mild to moderate active UC.Bifico is an effective agent in the treatment of mild to moderate active UC probably by decreasing expression of NF-κB.
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Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity, and topical mesalazine (5-aminosalicylic acid [5-ASA]) is known to inhibit the inflammatory processes in UP. We successfully devised mesalazine suppositories, in which 250mg mesalazine was equally distributed and remained stable for at least 2 weeks. We evaluated the effect of using mesalazine suppositories twice a day (BID) on two UP patients. The results demonstrated that mesalazine suppositories were efficacious, well tolerated and safe for the long-term maintenance of UP remission.
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Summary Background Mesalazine (mesalamine) is standard first line treatment for moderately active ulcerative colitis (UC). Recently, doubling the mesalazine dose (Asacol 4.8 g/day) was shown to improve efficacy with no increase in adverse events. The cost‐effectiveness of this strategy remains unknown. Aim To assess the cost‐utility of high dose (HD) mesalazine (Asacol 4.8 g/day) compared with standard dose (SD) mesalazine (Asacol 2.4 g/day) as first line treatment for moderately active UC. Methods The costs and benefits associated with a treatment pathway beginning with HD or SD mesalazine were determined over 12 weeks using a decision tree analytical model. Results A 12‐week treatment pathway starting with HD mesalazine cost an average of £2382 per patient compared with £2474 for SD mesalazine and generated 0.0016 more quality adjusted life years (QALYs). HD mesalazine dominated SD mesalazine, being both more effective and less costly. HD mesalazine treatment resulted in fewer patients requiring surgery or hospitalization for intensive pharmacological treatment. Probabilistic sensitivity analysis indicated a 72% chance that HD mesalazine was cost effective, based on a cost/QALY threshold of £30 000. Conclusions This study suggests that HD mesalazine represents a cost‐effective alternative to SD mesalazine for moderately active UC, while potentially reducing the need for hospitalization.
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Fish oil (FO) and mesalazine have well-known anti-inflammatory and antioxidant effects; on the other hand, information related to combined intrarectal administration of FO and mesalazine is limited. The present study was conducted to make comparison on therapeutic effectiveness of rectally administered FO and mesalazine in rats with trinitrobenzenesulfonic acid (TNBS)-induced colitis. Wistar rats were randomly assigned to 5 groups as (1) Control, (2) Colitis, (3) Colitis + Mesalazine (Colitis + M), (4) Colitis + Fish Oil (Colitis + F), and (5) Colitis + Mesalazine + Fish Oil (Colitis + M + F). Intrarectally administered TNBS induced colitis. At the end of the trial, the rats' macroscopic and histopathologic lesions were rated and tumour necrosis factor (TNF)-α, Interleukin 6 (IL6), glutathione reductase (GR), glutathione peroxidase (GP), myeloperoxidase (MPO), malondialdehyde (MDA), Superoxide dismutase (SOD), Total nitrate and nitrite, and catalase (CAT) in serum and tissue were detected. As a result of macroscopic and microscopic examination, although separate administrations of FO and mesalazine partly decreased the damage, their combined administration decreased the damage scores significantly (p < 0.01). It was observed that separate and combined administrations of FO and mesalazine decreased the increase in the serum and tissue TNF-α and IL-6 levels caused by colitis (p < 0.05). It was observed that the serum MPO, serum GR, tissue SOD, tissue nitrite/nitrate values of both Colitis + M and Colitis + F groups were close to the control in terms of all the parameter values in Colitis + M + F group (p > 0.05). Also based on the histological results, the inflammation damage in the tissue caused by colitis in the Colitis + M + F group recovered significantly. We found that microscopic and macroscopic damage, serum IL-6 level decreased and increased serum and tissue GP and tissue GR values in Colitis + M + F group compared to Colitis + M and Colitis + F groups. Combined intrarectal administration of FO and mesalazine may bring a new insight concerning the treatment of ulcerative colitis.
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Mesalazine is widely used in the treatment of inflammatory bowel disease. Little is known about the doseresponse relationship and about possible dose related side effects. In ulcerative colitis higher dosages of mesalazine (3 g) are more effective in maintaining a remission than lower dosages (1.5 g). In mild to moderately active ulcerative colitis, studies also indicate that higher dosages might be more effective in inducing remission. Dose‐comparing studies in Crohn′s disease are even more sparse, but the available results indicate higher efficacy at higher dose levels. None of the known side effects of mesalazine are clearly dose‐related. A pH‐dependent release system, however, can cause a sudden release of high doses of mesalazine. Consequent peak levels in serum have been implicated in mesalazine induced nephrotoxicity. In conclusion, despite the current practice of using increasing dosages of mesalazine in inflammatory bowel disease, both efficacy and safety have been established tentatively.
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Aliment Pharmacol Ther 2011; 34: 1115–1122 Summary Background Different oral formulations of 'mesalazine (mesalamine)' may have different efficacy in distal ulcerative colitis. Aim To evaluate the efficacy of mesalazine granules (Salofalk granules) vs. mesalazine tablets (Salofalk tablets) as induction therapy in patients with distinct extensions of ulcerative colitis. Methods A pooled analysis of 705 patients from four prospective, randomised, double-blind phase III trials was performed. The efficacy of 8 weeks' induction with 3 g/day mesalazine granules [3 g once daily (o.d.) or 1 g three times daily (t.d.s)] vs. 3 g/day mesalazine tablets (1 g t.d.s.) was compared in terms of clinical remission (CR: CAI ≤ 4) and endoscopic remission (ER: EI ≤ 3) (both according to Rachmilewitz) in subgroups with pancolitis, left-sided colitis, or proctosigmoiditis. Results Mesalazine granules were equipotent to mesalazine tablets in pancolitis regarding CR (72% vs. 71%, P = 0.909) and ER (58% vs. 49%, P = 0.338). In left-sided colitis, both mesalazine formulations were equipotent regarding CR (66% vs. 67%; P = 0.843) but mesalazine granules were superior regarding ER (56% vs. 37%; P = 0.025). In proctosigmoiditis, mesalazine granules were significantly more effective than mesalazine tablets regarding CR (78% vs. 55%P < 0.001) and ER (67% vs. 43%P < 0.001). Furthermore, o.d. application of mesalazine granules was more effective than t.d.s. dosing in left-sided colitis (CR 73% vs. 62%, P = 0.181; ER 71% vs. 48%P = 0.005) and proctosigmoiditis (CR 86% vs. 73%, P = 0.020; ER 75% vs. 61%, P = 0.021), but not in pancolitis. Conclusion This pooled analysis supports the hypothesis that mesalazine granules are superior to mesalazine tablets in induction of remission in distal colitis and should be taken once daily.
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DISTRIBUTION AND ANTI‐INFLAMMATORY EFFECT OF MESALAZINE ON CARRAGEENAN‐INDUCED COLITIS IN THE RABBIT
SUMMARY 1. A controlled‐release preparation of mesalazine microgranules (Pentasa R ; Ferring AS, Vanlose, Denmark) releases the active ingredient over a wide area from the small intestine to the rectum and is consequently expected to bring about therapeutic benefits to patients with ulcerative colitis and Crohn's disease. 2. Mesalazine microgranules (50 or 150 mg/kg per day) were administered orally to each rabbit with carrageenan‐induced colitis for six weeks. Its inhibitory effect on colonic mucosal damage was assessed in terms of the microscopic damage scores, leukotriene B 4 concentrations and concentrations of mesalazine derivatives. 3. At the end of the experiment, the mesalazine 150 mg group had gained a significantly greater bodyweight than the control group. Microscopic damage was significantly lower in the 150 mg group than in the untreated control group. Tissue concentrations of 5‐aminosalicylic acid and acetyl‐5‐aminosalicylic acid in the small and large intestine were higher in the 150 mg group than in the 50 mg group. Mucosal leukotriene B 4 levels tended to be lower in rabbits receiving the larger dose of mesalazine. 4. The present study indicates that slow release 5‐aminosalicylic acid at the larger dose reaches the large bowel in sufficiently high concentrations following oral administration and significantly reduces carrageenan‐induced colitis in the rabbit.
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