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- Article] An oral preparation of mesalamine as long-term maintenance therapy for ulcerative colitis - A randomized, placebo-controlled trial
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DocNo of ILP: 7778
Doc. Type: Article
Title: An oral preparation of mesalamine as long-term maintenance therapy for ulcerative colitis - A randomized, placebo-controlled trial
Authors: Hanauer, SB; Sninsky, CA; Robinson, M; Powers, BJ; McHattie, JD; Mayle, JE; Elson, CO; DeMicco, MP; Butt, JH; Pruitt, RE; Bozdech, JM; Safdi, MA; Gurney, MS; Fixelle, AM; Levin, AI; Smoots, J; Wolf, DC
Full Name of Authors: Hanauer, SB; Sninsky, CA; Robinson, M; Powers, BJ; McHattie, JD; Mayle, JE; Elson, CO; DeMicco, MP; Butt, JH; Pruitt, RE; Bozdech, JM; Safdi, MA; Gurney, MS; Fixelle, AM; Levin, AI; Smoots, J; Wolf, DC
Keywords by Author: colitis, ulcerative; mesalamine; sulfasalazine; polymers; absorption
Keywords Plus: INFLAMMATORY BOWEL-DISEASE; 5-AMINO SALICYLIC-ACID; 5-AMINOSALICYLIC ACID; SULFASALAZINE; SULPHASALAZINE; REMISSION; RELEASE; SALICYLAZOSULFAPYRIDINE; METABOLISM; MESALAZINE
Abstract: Objective: To compare the safety and efficacy of a pH-sensitive, polymer-coated oral formulation of mesalamine (Asacol, Procter & Gamble Pharmaceuticals, Cincinnati, Ohio) with those of placebo in maintaining remission in patients with ulcerative colitis. Design: Multicenter, double-blind, placebo-controlled, randomized clinical trial. Setting: Eight private practices, five university-based medical centers, and four hospitals or clinics. Patients: 264 patients with ulcerative colitis that had been maintained in remission for at least 1 month while the patients were receiving stable doses of sulfasalazine or any oral mesalamine product. Intervention: Coated mesalamine at oral dosages of 0.8 g/d or 1.6 g/d or matching placebo for 6 months. Measurements: Treatment success, defined as maintenance of remission after 6 months, and treatment failure, defined as relapse during the study (as indicated by proctosigmoidoscopy at 1, 3, or 6 months of treatment) or withdrawal due to adverse events. Safety was assessed on the basis of laboratory analyses and patient- and investigator-noted adverse events. Results: 189 patients were compliant with the protocol for 6 months or stopped receiving therapy because of relapse or adverse events. Of these 189 patients, 25 of the 63 patients (39.7%) in the placebo group had treatment success compared with 40 of the 68 patients (58.8% [95% CI, 46.4% to 71.3%]) in the group receiving mesalamine, 0.8 g/d (P = 0.036) and 38 of the 58 patients (65.5% [CI, 52.4% to 78.6%]) in the group receiving mesalamine, 1.6 g/d (P = 0.006). In the intention-to-treat analysis of all patients, 42 of the 87 patients (48.3%) in the placebo group had treatment success compared with 57 of the 90 patients (63.3% [CI, 52.8% to 73.8%]) in the group receiving mesalamine, 0.8 gld (P = 0.050) and 61 of the 87 patients (70.1% [CI, 59.9% to 80.3%]) in the group receiving mesalamine, 1.6 g/d (P = 0.005). Age, sex, and race were not found to predict treatment success or failure. The mesalamine tablet was well tolerated, and no clinically significant changes were seen in hematologic, hepatic, or renal laboratory profiles. Conclusion: Coated mesalamine at oral dosages of 0.8 g/d and 1.6 g/d is safe and effective in maintaining remission in patients with quiescent ulcerative colitis.
Cate of OECD: Clinical medicine
Year of Publication: 1996
Business Area: other
Detail Business: medicine & science
Country: USA
Study Area:
Name of Journal: ANNALS OF INTERNAL MEDICINE
Language: English
Country of Authors: UNIV FLORIDA,GAINESVILLE,FL; UNIV OKLAHOMA,COLL MED,OKLAHOMA CITY,OK; CLEVELAND CLIN,CLEVELAND,OH 44106; PORTLAND CLIN,PORTLAND,OR; WESTERN CLIN,TACOMA,WA; EMORY UNIV,ATLANTA,GA 30322; ARAPAHOE GASTROENTEROL,ENGLEWOOD,CO 80210; PASQUA HOSP,GASTROINTESTINAL UNIT,REGINA,SK S4T 1A5,CANADA; MICHIGAN STATE UNIV,GASTROENTEROL SERV,INGHAM MED PROFESS CTR,LANSING,MI 48910; UNIV ALABAMA,DIV GASTROENTEROL,BIRMINGHAM,AL 35294; ASSOCIATED GASTROENTEROL MED GRP,ANAHEIM,CA 92801; UNIV MISSOURI,SCH MED,HARRY S TRUMAN MEM VET HOSP,COLUMBIA,MO 65201; NASHVILLE MED RES INST,NASHVILLE,TN 37205; GREATER CINCINNATI GASTROENTEROL ASSOCIATES,CINCINNATI,OH 45219; EASTSIDE DIGEST DIS CLIN,KIRKLAND,WA 98034
Press Adress: Hanauer, SB (reprint author), UNIV CHICAGO HOSP,DIV GASTROENTEROL,5841 S MARYLAND AVE,BOX 400,CHICAGO,IL 60637, USA.
Email Address:
Citaion:
Funding:
Lists of Citation: Azad Khan AK, 1980, GUT, V21, P232; Azad Khan AK, 1977, LANCET, V2, P892; BACHRACH WH, 1988, AM J GASTROENTEROL, V83, P487; BARON JH, 1962, LANCET, V1, P1094; PORRO GB, 1989, GUT, V30, pA1467; CALDER IC, 1972, BRIT MED J, V1, P152; DAS KM, 1973, NEW ENGL J MED, V289, P491, DOI 10.1056/NEJM197309062891001; DEW MJ, 1982, BRIT MED J, V285, P1012; DEW MJ, 1983, BRIT MED J, V287, P23; DEW MJ, 1982, BRIT J CLIN PHARMACO, V14, P405; DEW MJ, 1983, LANCET, V2, P801; DEW MJ, 1983, BRIT J CLIN PHARMACO, V16, P185; DICK AP, 1964, GUT, V5, P437, DOI 10.1136/gut.5.5.437; DISSANAY.AS, 1973, GUT, V14, P923, DOI 10.1136/gut.14.12.923; DONALD IP, 1985, POSTGRAD MED J, V61, P1047; GIONCHETTI P, 1990, GASTROENTEROLOGY, V98, P251; KIRSNER JB, 1980, INFLAMMATORY BOWEL D; KLOTZ U, 1980, NEW ENGL J MED, V303, P1499, DOI 10.1056/NEJM198012253032602; MISIEWIC.JJ, 1965, LANCET, V1, P185; MULDER CJJ, 1988, GASTROENTEROLOGY, V95, P1449; NIELSEN OH, 1983, BRIT J CLIN PHARMACO, V16, P738; PEPPERCO.MA, 1972, J PHARMACOL EXP THER, V181, P555; PEPPERCORN MA, 1990, ANN INTERN MED, V112, P50; RIIS P, 1973, SCAND J GASTROENTERO, V8, P71; RILEY SA, 1988, GASTROENTEROLOGY, V94, P1383; RUTGEERTS P, 1989, ALIMENT PHARM THERAP, V3, P183; SCHROEDER KW, 1987, NEW ENGL J MED, V317, P1625, DOI 10.1056/NEJM198712243172603; SNINSKY CA, 1991, ANN INTERN MED, V115, P350; TAFFET SL, 1983, DIGEST DIS SCI, V28, P833, DOI 10.1007/BF01296907; VANHEES PAM, 1980, GUT, V21, P632, DOI 10.1136/gut.21.7.632
Number of Citaion: 30
Publication: AMER COLL PHYSICIANS
City of Publication: PHILADELPHIA
Address of Publication: INDEPENDENCE MALL WEST 6TH AND RACE ST, PHILADELPHIA, PA 19106-1572
ISSN: 0003-4819
29-Character Source Abbreviation: ANN INTERN MED
ISO Source Abbreviation: Ann. Intern. Med.
Volume: 124
Version: 2
Start of File: 204
End of File: &
DOI:
Number of Pages: 9
Web of Science Category: Medicine, General & Internal
Subject Category: General & Internal Medicine
Document Delivery Number: TQ016
Unique Article Identifier: WOS:A1996TQ01600003
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