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Background Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults. Aims Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission. Methods Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months. Results Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25–0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31–0.84; P = 0.009) that was sustained during the OLE. Conclusions MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. ClinicalTrials.gov NCT00744016, NCT00767728, and NCT00326209.

During topical dissolution of gallstones,solvent can escape to the duodenum causing toxic effectsthat have not yet been adequately quantified. Wecompared the local intestinal cytotoxic and systemichepatotoxic effects of two gallstone solvents, methyltert-butyl ether and ethyl propionate, on the rabbit'sduodenum. Methyl tert-butyl ether, ethyl propionate, orsaline (control) was infused intraduodenally for 3 hr in 32 male New Zealand rabbits. Thesolvents were infused either at a high infusion rate of8.5 μl/min or at a low rate of 4.0 μl/min. Bloodsamples were collected for biochemical analysis fromeach animal before and after the 3-hr infusionperiod. A standardized histologic scoring system wasused by a pathologist blinded to the treatments toquantify liver and intestinal tissue injury. None of the animals studied showed any significant changesin serum alkaline phosphatase, amylase, bilirubin, ortheir hepatic histology or histologic scoring formucosal necrosis and ulceration. At the higher dose, methyl tert-butyl ether produced significantlymore submucosal inflammation (P = 0.0017) and showed atrend of causing more submucosal edema than ethylpropionate, but ethyl propionate led to significantly higher elevations of aminotransferases thanmethyl tert-butyl ether as compared to saline. Therewere no detectable blood levels of methanol or ethanolin any of the animals studied. Ethyl propionate may be less damaging to the intestinal mucosa ofthe rabbit than methyl tert-butyl ether, but at thehigher dose (equivalent to 60 ml/3 hr in a 70-kg human)it appears to produce more biochemical liver injury when administered intraduodenally.