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53. P510 European multicenter trial of budesonide and mesalazine for short-term treatment of active collagenous colitis (BUC60/COC)

Author

Miehlke, S., primary, Madisch, A., additional, Kupcinskas, L., additional, Petrauskas, D., additional, Heptner, G., additional, Böhm, G., additional, Marks, H.-J., additional, Neumeyer, M., additional, Nathan, T., additional, Fernández-Bañares, F., additional, Greinwald, R., additional, Mohrbacher, R., additional, Vieth, M., additional, and Bonderup, O., additional

Published
2013
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54. P567 Budesonide induces clinical remission and improves quality of life in active collagenous colitis: results from the open-label induction phase of BUC-63/COC

Author

Münch, A., primary, Bohr, J., additional, Benoni, C., additional, Olesen, M., additional, Öst, Å., additional, Hjortswang, H., additional, Hellström, P.M., additional, Strandberg, L., additional, Björk, J., additional, Hertervig, E., additional, Lindberg, G., additional, Lapidus, A., additional, Löfberg, R., additional, Miehlke, S., additional, Kirsch, C., additional, Armerding, P., additional, Bonderup, O., additional, Stehlik, J., additional, Müller, R., additional, Greinwald, R., additional, Tysk, C., additional, and Ström, M., additional

Published
2013
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55. P608 Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in Crohn's disease patients with endoscopic recurrence: follow-up data of a randomised, double-blind, double-dummy, 1-year, multicentre trial

Author

Reinisch, W., primary, Angelberger, S., additional, Petritsch, W., additional, Shonova, O., additional, Lukas, M., additional, Greinwald, R., additional, Mueller, R., additional, Stange, E.F., additional, and Herrlinger, K., additional

Published
2013
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59. Relationship between Thiopurine metabolite levels and endoscopic improvement in patients with postoperative moderate to severe endoscopic recurrence of Crohn's disease

Author

Angelberger, S, primary, Schaeffeler, E, additional, Teml, A, additional, Petritsch, W, additional, Shonova, O, additional, Lukas, M, additional, Bar-Meir, S, additional, Greinwald, R, additional, Mueller, R, additional, Stange, EF, additional, Herrlinger, KR, additional, Schwab, M, additional, and Reinisch, W, additional

Published
2010
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60. Ein neues 1g Mesalazin-Suppositorium (Salofalk®) ist bei mittelschwerer proctitis ulcerosa genauso wirksam wie die 3 x tägliche Gabe von 500mg Suppositorien: Eine randomisierte multizentrische Studie

Author

Andus, T, primary, Kocjan, A, additional, Müser, M, additional, Simanenkov, V, additional, Baranovsky, A, additional, Mikhailova, TL, additional, Zvyagintseva, TD, additional, Dorofeyev, A, additional, Lozynskyy, Y, additional, Lavy, A, additional, Mohrbacher, R, additional, and Greinwald, R, additional

Published
2009
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61. P206 - Which patient population profits best from a high dose, once daily treatment with 3.0g mesalazine for maintaining clinical remission in ulcerative colitis? A subgroup analysis of a double-blind, double-dummy, randomised, controlled, dose-ranging study

Author

Kruis, W., primary, Jonaitis, L., additional, Kupcinskas, L., additional, Pokrotnieks, J., additional, Acute, G., additional, Mikhailova, T.L., additional, Horynski, M., additional, Batovsky, M., additional, Lozinskii, Y.S., additional, Racz, I., additional, Kull, K., additional, Vcev, A., additional, Faszczyk, M., additional, Greinwald, R., additional, and Mueller, R., additional

Published
2009
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76. Gastrointestinal transit and release of 5-aminosalicylic acid from 153 Sm-labelled mesalazine pellets vs. tablets in male healthy volunteers.

Author

Brunner, M., Greinwald, R., Kletter, K., Kvaternik, H., Corrado, M. E., Eichler, H. G., and Müller, M.

Subjects
*GASTROINTESTINAL system, *SALICYLIC acid, *MEN, *INTESTINAL diseases
Abstract

Summary Background : Mesalazine (5-aminosalicylic acid)-containing formulations, designed to optimize drug delivery to the ileo-caecal region, represent a cornerstone in the treatment of inflammatory bowel diseases. Aim : To test, by means of pharmaco-scintigraphy, whether novel mesalazine-containing pellets release 5-aminosalicylic acid in the same target region as mesalazine tablets (Salofalk). Methods : Fourteen healthy male volunteers received a single dose of either pellets or tablets containing 500 mg of mesalazine and 2 mg of 152 Sm2 O3 with a 1-week washout period. The gastrointestinal transit of 153 Sm, incorporated into the formulations, was followed by gamma-scintigraphy. Mesalazine release was verified by assessing 5-aminosalicylic acid plasma pharmacokinetics. Results : The formulations reached the ileo-caecal target region almost at the same time (3.3 ± 1 and 3.8 ± 1 h for pellets and tablets, respectively). Plasma 5-aminosalicylic acid t max values were comparable and corresponded to the time during which the formulations were located in the target region. Plasma AUC values were significantly lower for pellets, which might be explained by a more prolonged release of 5-aminosalicylic acid. Conclusions : Novel mesalazine pellets and Salofalk tablets release active 5-aminosalicylic acid in the same target region and pass through the gastrointestinal tract under fasting conditions in healthy volunteers in a comparable time. From a comparison of in vitro dissolution and plasma concentration data, a slower and more prolonged release of 5-aminosalicylic acid from pellets is suggested. [ABSTRACT FROM AUTHOR]

Published
2003
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77. The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: A dose-finding study with newly developed mesalamine

Author

Kruis, W., Bar-Meir, S., Feher, J., Mickisch, O., Mlitz, H., Faszczyk, M., Chowers, Y., Lengyele, G., Kovacs, A., Lakatos, L., Stolte, M., Vieth, M., and Greinwald, R.

Abstract

Background & Aims: 5-Aminosalicylate is the gold standard for inducing remission in patients with mildly to moderately active ulcerative colitis. The optimal dose is as yet not defined. Despite some recent developments, the ideal formulation for 5-aminosalicylic acid is still awaited. A new pellet preparation was designed combining slow and delayed release properties. Aims of the study were to find the optimal dose and to test efficacy and safety of a new 5-aminosalicylic acid formulation. Methods: Three hundred twenty-one patients were included in a double-blind multicenter trial. Inclusion criteria were active ulcerative colitis (Clinical Activity Index [CAI] and Endoscopic Index [EI] according to Rachmilewitz, CAI 6-12; EI >=4). Three different doses of 5-aminosalicylic acid (0.5 g 3 times a day, 1.0 g 3 times a day, and 1.5 g 3 times a day) were studied for 8 weeks. Results: Clinical remission rate (CAI @?4) was highest in the 1.0 g 3 times a day group (66 %), 50% in the 0.5 g 3 times a day group, and 55% in the 1.5 g 3 times a day group. Hierarchical testing showed no significance, indicating a lack of dose response across the 3 mesalamine doses. In addition, times to first clinical response were similar: 26.5 days (1.0 g 3 times a day), 27.5 days (0.5 g 3 times a day), and 21.5 days (1.5 g 3 times a day). Endoscopic improvement was better with 1.0 g mesalamine 3 times a day than with 0.5 g 3 times a day, but overall endoscopic and histologic improvement was not different between treatment groups. Baseline activity, duration, and localization of ulcerative colitis did have some influence on the therapeutic activity, but there was no significant interaction with the dose of the study drug. Safety, with special focus on kidney function, was excellent in all 3 groups. Conclusions: There is no significant dose response between mesalamine 1.5 g/day, 3.0 g/day, and 4.5 g/day. The optimal dose to induce remission of ulcerative colitis is 0.5 g 5-aminosalicylic acid 3 times a day. Patients failing with this dose may benefit from an increase of the dose up to 1.0 g 3 times a day, but should also be considered for alternative treatment. A newly developed pellet formulation of 5-aminosalicylic acid has promising efficacy and excellent safety. CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2003;1:36-43

Published
2003
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78. norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis

Author

Fickert, P, Hirschfield, G, Denk, G, Marschall, H, Altorjay, I, Färkkilä, M, Schramm, C, Spengler, U, Chapman, R, Bergquist, A, Schrumpf, E, Nevens, F, Trivedi, P, Reiter, F, Tornai, I, Halilbasic, E, Greinwald, R, Pröls, M, Manns, M, Trauner, M, Group, European Psc Norudca Study, Clinicum, Department of Medicine, University of Helsinki, Gastroenterologian yksikkö, and HUS Abdominal Center

Subjects
Male, 0301 basic medicine, LIVER FIBROSIS, Gastroenterology, law.invention, 0302 clinical medicine, Primary biliary cirrhosis, Randomized controlled trial, law, QUALITY-OF-LIFE, Medicine, BILE-ACIDS, Cholestasis, Orvostudományok, Middle Aged, Side chain-shortened bile acids, Ursodeoxycholic acid, 3. Good health, SURVIVAL, Alkaline phosphatase, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, medicine.medical_specialty, Cholangitis, Sclerosing, Placebo, Klinikai orvostudományok, CONTROLLED-TRIAL, Primary sclerosing cholangitis, Cholehepatic shunting, 03 medical and health sciences, Double-Blind Method, INFLAMMATION, Internal medicine, Humans, PRIMARY BILIARY-CIRRHOSIS, Dose-Response Relationship, Drug, Hepatology, business.industry, DOSE URSODEOXYCHOLIC ACID, medicine.disease, 030104 developmental biology, ALKALINE-PHOSPHATASE, Concomitant, 3121 General medicine, internal medicine and other clinical medicine, Bile acid treatment, business, KNOCKOUT MICE, Sclerosing cholangitis
Abstract

Background & Aim: Primary sclerosing cholangitis (PSC) represents a devastating bile duct disease, currently lacking effective medical therapy. 24-norursodeoxycholic acid (norUDCA) is a side chain-shortened C-23 homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. A randomized controlled trial, including 38 centers from 12 European countries, evaluated the safety and efficacy of three doses of oral norUDCA (500 mg/d, 1,000 mg/d or 1,500 mg/d) compared with placebo in patients with PSC. Methods: One hundred sixty-one PSC patients without concomitant UDCA therapy and with elevated serum alkaline phosphatase (ALP) levels were randomized for a 12-week treatment followed by a 4-week follow-up. The primary efficacy endpoint was the mean relative change in ALP levels between baseline and end of treatment visit. Results: norUDCA reduced ALP levels by -12.3%, -17.3%, and -26.0% in the 500, 1,000, and 1,500 mg/d groups (p = 0.029, tively, while a +1.2% increase was observed in the placebo group. Similar dose-dependent results were found for secondary end-points, such as ALT, AST, gamma-GT, or the rate of patients achieving ALP levels

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80. Taxonomic significance of alkaloids in the genus Liparia(Fabaceae – Liparieae)

Author

van Wyk, B.-E., Verdoorn, G.H., and Greinwald, R.

Abstract

Comparative GC and GC–MS analyses of the alkaloids of Liparia splendens(Burm. f.) Bos & De Wit and L. parvaVog. ex Walp. have shown that the two species differ considerably. L. splendenscontains ammodendrine (a bipiperidyl compound) as major alkaloid, while L. parvahas sparteine, lupanine and other quinolizidine alkaloids as major alkaloids. Only small quantities of bipiperidyl alkaloids were present in the latter. The two species of Lipariaare morphologically similar and the different alkaloid patterns are therefore quite unexpected. Our results support the idea that different pollination mechanisms may lead to an enlarged taxonomic distance between closely related species.

Published
1991
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81. Chemotaxonomic significance of alkaloids in the genus Spartidium(Fabaceae — Crotalarieae)

Author

van Wyk, B-E., Greinwald, R., Verdoorn, G.H., and Witte, L.

Abstract

The presence of alkaloids in the monotypic North African genus SpartidiumPomel is reported for the first time. Comparative GC and MS analyses showed that S. saharae(Coss.) Pomel contains the bipiperidyl compounds ammodendrine and N′-formylammodendrine as major and minor alkaloids respectively. In addition, sparteine (a quinolizidine alkaloid) and two isomers of N-cinnamoylhistamine (an imidazole derivative) were present in small quantities. The morphological similarities between Spartidiumand the genus LebeckiaThunb. are not reflected in the alkaloid patterns. In Spartidiumonly a trace of one quinolizidine alkaloid was detected. Ammodendrine, the major Spartidiumalkaloid, is absent or occurs only as a trace amount in Lebeckia.The results provide supporting evidence for Polhill’s (1976) decision to retain Spartidiumas a distinct genus rather than to consider it a species of Lebeckia.

Published
1989
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87. The alkaloid pattern of Cytisophyllum sessilifolium(Fabaceae-Genisteae)

Author

Greinwald, R., Witte, L., Wray, V., and Czygan, F.-C.

Abstract

A survey of alkaloids from Cytisophyllum sessilifoliumhas shown the presence of several quinolizidine and dipiperidine alkaloids. The investigation afforded a new alkaloid, 7-hydroxylupanine. The structure of this alkaloid was assigned spectroscopically, α-Isosparteine, sparteine, β-isosparteine, ammodendrine, lusitanine, isolupanine, 5,6-dehydrolupanine, lupanine, a tentative dihydroxylupanine, cis-adenocarpine and trans-adenocarpine have been found. The co-occurrence of quinolizidine alkaloids and adenocarpine appears to be a good chemotaxonomic character of the genus Cytisophyllum.

Published
1991
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88. Mesalazine foam (Salofalk® foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalko® enema

Author

SANDRO ARDIZZONE, Doldo, P., Ranzi, T., Sturniolo, G. C., Giglio, L. A., Annese, V., D Arienzo, A., Gaia, E., Gullini, S., Riegler, G., Valentini, M., Massa, P., Del Piano, M., Rossini, F., Sategna Guidetti, C., Pera, A., Greinwald, R., Bianchi Porro, G., Andriulli, A., Lombardi, G., Rotondo, S. G., Fiorentini, M. T., Caula, G., Grosso, S. B., Pennazio, M., Cavallero, M., Cosintino, R., Prantera, C., Sambataro, A., Gallo, M., Scaglione, G., Bennato, R., Cantarini, D., Orsello, M., Bianchi, P. A., Piodi, L., Fornasarig, M., Parrello, T., Pallone, F., D Inca, R., Ferronato, A., Morace, F., and Tartaglione, M. T.

89. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis

Author

Kruis W., Neshta V., Pesegova M., Alekseeva O., Andreev P., Datsenko O., Levchenko O., Abdulkhakov S., Lozynskyy Y., Mostovoy Y., Soloviev K., Dorofeyev A., Vieth M., Stiess M., Greinwald R., Mohrbacher R., Siegmund B., Kruis W., Neshta V., Pesegova M., Alekseeva O., Andreev P., Datsenko O., Levchenko O., Abdulkhakov S., Lozynskyy Y., Mostovoy Y., Soloviev K., Dorofeyev A., Vieth M., Stiess M., Greinwald R., Mohrbacher R., and Siegmund B.

Abstract

© 2019 AGA Institute Background & Aims: Although proctitis is the most limited form of ulcerative colitis, it causes unpleasant symptoms. Topical mesalamine, the standard treatment, is not always effective. We conducted a randomized phase 2 trial to determine the efficacy and safety of 2 doses of a budesonide suppository vs mesalamine suppositories vs combined budesonide and mesalamine suppositories for proctitis. Methods: We performed a prospective, double-blind, double-dummy, multicenter trial in 337 patients with active proctitis to compare the efficacies of 4 different suppository treatments. Patients were randomly assigned to groups given 2 mg budesonide suppositories (2 mg BUS; n = 89 patients), 4 mg BUS (n = 79), 1 g mesalamine suppositories (1 g MES; n = 81), or the combination of 2 mg BUS and 1 g MES (n = 88). The study was performed from November 2013 through July 2015 at 36 study sites in Europe and Russia. The primary end point was the time to resolution of clinical symptoms, defined as the first of 3 consecutive days with a score of 0 for rectal bleeding and stool frequency. Results: The mean time to resolution of symptoms in the 4 mg BUS (29.8 days) and combination of 2 mg BUS and 1 g MES (29.3 days) groups resembled that of the standard 1 g MES treatment (29.2 days), but was significantly longer in the 2 mg BUS group (35.5 days). Furthermore, proportions of patients with deep, clinical, and endoscopic remission, as well as mucosal healing, were similar among the 1 g MES, 4 mg BUS, and combination therapy groups, but significantly lower in the group that received 2 mg BUS. No safety signals were observed, and the patients’ treatment acceptance was high (67%–85% of patients). Conclusions: In a multicenter randomized trial, we found that the efficacy and safety of 4 mg BUS in treatment of active proctitis did not differ significantly from those of 1 g MES. Budesonide suppositories offer an alternative therapy to mesalamine for topical treatment of procti

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