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https://www.readbyqxmd.com/read/27158764/oral-5-aminosalicylic-acid-for-maintenance-of-remission-in-ulcerative-colitis
#1
REVIEW
Yongjun Wang, Claire E Parker, Brian G Feagan, John K MacDonald
BACKGROUND: Oral 5-aminosalicylic (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs were more effective than placebo but had a statistically significant therapeutic inferiority relative to SASP. This updated review includes more recent studies and evaluates the effectiveness, dose-responsiveness, and safety of 5-ASA preparations used for maintenance of remission in quiescent ulcerative colitis...
2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27101467/oral-5-aminosalicylic-acid-for-induction-of-remission-in-ulcerative-colitis
#2
REVIEW
Yongjun Wang, Claire E Parker, Tania Bhanji, Brian G Feagan, John K MacDonald
BACKGROUND: Oral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs in doses of at least 2 g/day, were more effective than placebo but no more effective than SASP for inducing remission in ulcerative colitis. This updated review includes more recent studies and evaluates the efficacy and safety of 5-ASA preparations used for the treatment of mild to moderately active ulcerative colitis...
April 21, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/26072136/-cost-effectiveness-assessment-through-theoretical-cost-minimization-analysis-of-the-use-of-two-gastro-resistant-modified-release-mesalazine-formulations-in-the-management-of-ulcerative-colitis-in-spain
#3
Javier P Gisbert, Fernando Gomollón, Ignacio Méndez
INTRODUCTION: The prevalence of ulcerative colitis (UC) and its associated economic burden is increasing in Spain. Oral mesalazines, which are the recommended first-line treatment for mild-moderate UC, show considerable variability in their formulations and prices. OBJECTIVE: To carry out a cost-effectiveness assessment of the use of the two formulations of oral gastro-resistant modified-release mesalazine formulations marketed in Spain (Salofalk(®) and Mezavant(®)) for the phases of induction of remission and its maintenance...
March 2016: Gastroenterología y Hepatología
https://www.readbyqxmd.com/read/25951927/release-of-5-aminosalicylic-acid-5-asa-from-mesalamine-formulations-at-various-ph-levels
#4
Adeyinka Abinusawa, Srini Tenjarla
INTRODUCTION: Oral formulations of 5-aminosalicylic acid (5-ASA) for treatment of ulcerative colitis have been developed to minimize absorption prior to the drug reaching the colon. In this study, we investigate the release of 5-ASA from available oral mesalamine formulations in physiologically relevant pH conditions. METHODS: Release of 5-ASA from 6 mesalamine formulations (APRISO®, Salix Pharmaceuticals, Inc., USA; ASACOL® MR, Procter & Gamble Pharmaceuticals UK Ltd...
May 2015: Advances in Therapy
https://www.readbyqxmd.com/read/25721685/gastrointestinal-release-behaviour-of-modified-release-drug-products-dynamic-dissolution-testing-of-mesalazine-formulations
#5
Alvaro Goyanes, Grace B Hatton, Hamid A Merchant, Abdul W Basit
The aminosalicylate mesalazine (mesalamine) forms the mainstay of treatment in ulcerative colitis (UC), a disease for which many commercial modified-release products have been developed with the aim of providing targeted gastrointestinal release. The release profiles of five of these commercial formulations were evaluated in bicarbonate buffer using a novel dissolution model that mimics the dynamic conditions of the gastrointestinal tract. Monolithic and multi-particulate mesalazine formulations with pH-dependent and/or independent release mechanisms were evaluated (Asacol(®) 800, Octasa(®), Mezavant(®) XL, Salofalk(®), Pentasa(®)), and each of the products displayed a distinctive dissolution profile...
April 30, 2015: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/25285021/long-term-efficacy-and-safety-of-once-daily-mesalazine-granules-for-the-treatment-of-active-ulcerative-colitis
#6
REVIEW
Stephan Karl Böhm, Wolfgang Kruis
In 1977, 5-aminosalicylic acid (5-ASA) was discovered as a therapeutically active moiety of sulfasalazine (SASP) and was launched for topical and oral therapy of ulcerative colitis (UC) in 1984. As a first-step, delivery systems had to be developed to protect 5-ASA against absorption in the upper gastrointestinal tract, resulting in different and competing strategies (azo compounds, controlled release, and pH-dependent release). In a second step, at the beginning of the new century, coinciding with the expiration of patent protection for the first 5-ASA formulations, two component composite release mechanisms (pH-dependent and controlled release) were developed...
2014: Clinical and Experimental Gastroenterology
https://www.readbyqxmd.com/read/24440672/budesonide-is-more-effective-than-mesalamine-or-placebo-in-short-term-treatment-of-collagenous-colitis
#7
RANDOMIZED CONTROLLED TRIAL
Stephan Miehlke, Ahmed Madisch, Limas Kupcinskas, Dalius Petrauskas, Günter Böhm, Hans-Joachim Marks, Michael Neumeyer, Torben Nathan, Fernando Fernández-Bañares, Roland Greinwald, Ralf Mohrbacher, Michael Vieth, Ole K Bonderup
BACKGROUND & AIMS: Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled, multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis. METHODS: Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk, n = 30), mesalamine granules (3 g mesalamine once daily, Salofalk, n = 25), or placebo for 8 weeks (n = 37) in a double-blind, double-dummy fashion...
May 2014: Gastroenterology
https://www.readbyqxmd.com/read/23899280/mesalazine-in-treating-diverticular-disease-of-the-colon
#8
COMMENT
Antonio Tursi
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...
July 2013: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/23414061/randomised-clinical-trial-mesalazine-salofalk-granules-for-uncomplicated-diverticular-disease-of-the-colon-a-placebo-controlled-study
#9
RANDOMIZED CONTROLLED TRIAL
W Kruis, E Meier, M Schumacher, O Mickisch, R Greinwald, R Mueller
BACKGROUND: Robust evidence regarding medical intervention for symptomatic uncomplicated colonic diverticular disease (DD) is sparse. AIM: To investigate mesalazine (Salofalk granules) in this setting. METHODS: In a double-blind, placebo-controlled, multicentre, 6-week trial, patients were randomised to mesalazine 1000 mg three times daily or placebo. Primary efficacy endpoint was change in lower abdominal pain to week 4 (baseline defined using pain score from 7 days pre-treatment)...
April 2013: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/23115226/extended-release-mesalamine-granules-for-ulcerative-colitis
#10
REVIEW
Bryan L Love, April D Miller
OBJECTIVE: To evaluate the efficacy and safety of extended-release mesalamine granules in the maintenance of remission in ulcerative colitis (UC). DATA SOURCES: Literature was obtained through searches of MEDLINE (1990-June 2012) using the terms mesalamine granules, ulcerative colitis, Apriso, and Salofalk. Bibliographies from retrieved articles were searched for additional citations. STUDY SELECTION AND DATA EXTRACTION: All English-language articles reporting on use of extended-release mesalamine granules in humans identified through the search were evaluated and included...
November 2012: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/23076890/oral-5-aminosalicylic-acid-for-maintenance-of-remission-in-ulcerative-colitis
#11
REVIEW
Brian G Feagan, John K Macdonald
BACKGROUND: Oral 5-aminosalicylic (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs were more effective than placebo but had a statistically significant therapeutic inferiority relative to SASP. This updated review includes more recent studies and evaluates the effectiveness, dose-responsiveness, and safety of 5-ASA preparations used for maintenance of remission in quiescent ulcerative colitis...
2012: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/23076889/oral-5-aminosalicylic-acid-for-induction-of-remission-in-ulcerative-colitis
#12
REVIEW
Brian G Feagan, John K Macdonald
BACKGROUND: Oral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs in doses of at least 2 g/day, were more effective than placebo but no more effective than SASP for inducing remission in ulcerative colitis. This updated review includes more recent studies and evaluates the efficacy and safety of 5-ASA preparations used for the treatment of mild to moderately active ulcerative colitis...
2012: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/21923715/mesalazine-granules-are-superior-to-eudragit-l-coated-mesalazine-tablets-for-induction-of-remission-in-distal-ulcerative-colitis-a-pooled-analysis
#13
L Leifeld, R Pfützer, J Morgenstern, P R Gibson, Y Marakhouski, R Greinwald, R Mueller, W Kruis
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...
November 2011: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/21453882/3g-mesalazine-granules-are-superior-to-9mg-budesonide-for-achieving-remission-in-active-ulcerative-colitis-a-double-blind-double-dummy-randomised-trial
#14
RANDOMIZED CONTROLLED TRIAL
Volker Gross, Ivan Bunganic, Elena A Belousova, Tatyana L Mikhailova, Limas Kupcinskas, Gediminas Kiudelis, Zsolt Tulassay, Libor Gabalec, Andrey E Dorofeyev, Jelena Derova, Karin Dilger, Roland Greinwald, Ralph Mueller
BACKGROUND AND AIMS: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD. METHODS: This was an eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ≥6 and Endoscopic Index (EI) ≥4, received budesonide (Budenofalk® 3mg capsules×3) or mesalazine (Salofalk® 1000mg granules×3)...
April 2011: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/21138455/randomised-clinical-trial-a-comparative-dose-finding-study-of-three-arms-of-dual-release-mesalazine-for-maintaining-remission-in-ulcerative-colitis
#15
RANDOMIZED CONTROLLED TRIAL
W Kruis, L Jonaitis, J Pokrotnieks, T L Mikhailova, M Horynski, M Bátovský, Y S Lozynsky, Y Zakharash, I Rácz, K Kull, A Vcev, M Faszczyk, K Dilger, R Greinwald, R Mueller et al.
BACKGROUND: Comparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited. AIM: To evaluate whether 3.0 g mesalazine once-daily (OD) is superior to the standard treatment of 0.5 g mesalazine three times daily (t.d.s.) and to prove the therapeutic equivalence of OD vs. t.d.s. dosing of total 1.5 g mesalazine for remission maintenance in patients with ulcerative colitis. METHODS: A 1-year, multicentre, double-blind, double-dummy study was undertaken in patients with endoscopically and histologically confirmed ulcerative colitis in remission...
February 2011: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/20396718/artrofoon-as-alternative-preparation-in-the-treatment-of-uncomplicated-forms-of-nonspecific-ulcerative-colitis
#16
A M Osadchuk, M A Osadchuk
Therapy of uncomplicated nonspecific ulcerative colitis with artrofoon effectively reduces the duration and number of relapses. During remissions, the count of apudocytes, serotonin-, melatonin-, vasointestinal peptide-producing, and mast cells and the parameters of cell homeostasis against the background of artrofoon therapy were much closer to the normal than during treatment with salofalk.
September 2009: Bulletin of Experimental Biology and Medicine
https://www.readbyqxmd.com/read/20310020/clinical-trial-a-novel-high-dose-1-g-mesalamine-suppository-salofalk-once-daily-is-as-efficacious-as-a-500-mg-suppository-thrice-daily-in-active-ulcerative-proctitis
#17
RANDOMIZED CONTROLLED TRIAL
Tilo Andus, Andreas Kocjan, Moritz Müser, Andrey Baranovsky, Tatyana L Mikhailova, Tatyana D Zvyagintseva, Andrey E Dorofeyev, Yurii S Lozynskyy, Ingolf Cascorbi, Manfred Stolte, Michael Vieth, Karin Dilger, Ralf Mohrbacher, Roland Greinwald et al.
BACKGROUND: Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository. METHODS: This was a single-blind (investigator-blinded), randomized, multicenter, comparative, Phase III clinical trial...
November 2010: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/19897969/primary-sclerosing-cholangitis-a-clinical-case
#18
Natalya B Gubergrits
The basic hypotheses of pathogenesis of primary sclerosing cholangitis (PSC) are discussed, i.e. genetically conditioned pathology, autoimmune pathology, the result of inflammatory reaction in bile ducts, and cholangiopathy. A clinical case of monozygotic twins with association of PSC and non-specific ulcerative colitis (NUC) is presented. The first twin had a severe course of PSC and a mild course of NUC; he died due to bacterial complications of cholangitis. The second twin, patient B, had an opposite situation, a severe course of NUC, while PSC was suspected only after determination of cholestasis biochemical markers...
2009: Digestive Diseases
https://www.readbyqxmd.com/read/18832520/once-daily-versus-three-times-daily-mesalazine-granules-in-active-ulcerative-colitis-a-double-blind-double-dummy-randomised-non-inferiority-trial
#19
RANDOMIZED CONTROLLED TRIAL
W Kruis, G Kiudelis, I Rácz, I A Gorelov, J Pokrotnieks, M Horynski, M Batovsky, J Kykal, S Boehm, R Greinwald, R Mueller
OBJECTIVES: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis. DESIGN: A randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III non-inferiority study. SETTING: 54 centres in 13 countries. PATIENTS: 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis (clinical activity index (CAI)>4 and endoscopic index > or =4 at baseline) were randomised and treated...
February 2009: Gut
https://www.readbyqxmd.com/read/18547758/impairment-of-the-in-vitro-drug-release-behaviour-of-oral-modified-release-preparations-in-the-presence-of-alcohol
#20
Hala M Fadda, Mohamed A M Mohamed, Abdul W Basit
Recently, there has been concern by regulatory authorities of the risk of alcohol-induced dose dumping of oral modified release (MR) formulations. The aim of this work was to use in vitro dissolution methodology to investigate the vulnerability of MR products to alcohol under different physiological conditions of the upper gastrointestinal tract. A variety of dissolution scenarios with ethanol concentrations in the range of 5-40% v/v were explored. Mesalazine (5-aminosalicylic acid) was selected as the model drug and the release behaviour of three commercially available MR, monolithic and multi-particulate preparations with pH-dependent or independent release mechanisms was evaluated (Salofalk, Asacol and Pentasa)...
August 6, 2008: International Journal of Pharmaceutics
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