메뉴 건너뛰기




Volumn 16, Issue 11, 2010, Pages 1947-1956

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

(14)  Andus, Tilo a   Kocjan, Andreas b   Müser, Moritz b   Baranovsky, Andrey c   Mikhailova, Tatyana L d   Zvyagintseva, Tatyana D e   Dorofeyev, Andrey E f   Lozynskyy, Yurii S g   Cascorbi, Ingolf h   Stolte, Manfred i   Vieth, Michael i   Dilger, Karin j   Mohrbacher, Ralf j   Greinwald, Roland j  


Author keywords

distal ulcerative colitis; mesalamine; N acetyltransferase; once daily; proctitis; suppository

Indexed keywords

MESALAZINE;

EID: 78249266327     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1002/ibd.21258     Document Type: Article
Times cited : (52)

References (40)
  • 1
    • 4344602852 scopus 로고    scopus 로고
    • Guidelines for the management of inflammatory bowel disease in adults
    • Carter MJ, Lobo AJ, Travis SPL, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2004; 53: V1-V16.
    • (2004) Gut. , vol.53
    • Carter, M.J.1    Lobo, A.J.2    Travis, S.P.L.3
  • 2
    • 2442526434 scopus 로고    scopus 로고
    • Medical therapy for ulcerative colitis 2004
    • Hanauer SB,. Medical therapy for ulcerative colitis 2004. Gastroenterology. 2004; 126: 1582-1592.
    • (2004) Gastroenterology , vol.126 , pp. 1582-1592
    • Hanauer, S.B.1
  • 3
    • 4844225502 scopus 로고    scopus 로고
    • Review article: Aminosalicylates in inflammatory bowel disease
    • Hanauer SB,. Review article: aminosalicylates in inflammatory bowel disease. Aliment Pharmacol Ther. 2004; 20: 60-65.
    • (2004) Aliment Pharmacol Ther. , vol.20 , pp. 60-65
    • Hanauer, S.B.1
  • 4
    • 7044243293 scopus 로고    scopus 로고
    • Diagnosis and therapy of ulcerative colitis: Results of an evidence based consensus conference by the German Society of Digestive and Metabolic Diseases and the Competence Network on Inflammatory Bowel Disease (in German)
    • Hoffmann JC, Zeitz M, Bischoff SC, et al. Diagnosis and therapy of ulcerative colitis: Results of an evidence based consensus conference by the German Society of Digestive and Metabolic Diseases and the Competence Network on Inflammatory Bowel Disease (in German). Z Gastroenterol. 2004; 42: 979-1032.
    • (2004) Z Gastroenterol. , vol.42 , pp. 979-1032
    • Hoffmann, J.C.1    Zeitz, M.2    Bischoff, S.C.3
  • 5
    • 3843109109 scopus 로고    scopus 로고
    • Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee
    • Kornbluth A, Sachar DB,. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2004; 99: 1371-1385.
    • (2004) Am J Gastroenterol. , vol.99 , pp. 1371-1385
    • Kornbluth, A.1    Sachar, D.B.2
  • 6
    • 38749095183 scopus 로고    scopus 로고
    • European evidence-based Consensus on the management of ulcerative colitis: Current management
    • Travis SPL, Stange EF, Lémann M, et al. European evidence-based Consensus on the management of ulcerative colitis: current management. J Crohn Colitis. 2008; 2: 24-62.
    • (2008) J Crohn Colitis , vol.2 , pp. 24-62
    • Travis, S.P.L.1    Stange, E.F.2    Lémann, M.3
  • 7
    • 49349100984 scopus 로고    scopus 로고
    • PPARgamma is involved in mesalazine-mediated induction of apoptosis and inhibition of cell growth in colon cancer cells
    • Schwab M, Reynders V, Loitsch S, et al. PPARgamma is involved in mesalazine-mediated induction of apoptosis and inhibition of cell growth in colon cancer cells. Carcinogenesis. 2008; 29: 1407-1414.
    • (2008) Carcinogenesis , vol.29 , pp. 1407-1414
    • Schwab, M.1    Reynders, V.2    Loitsch, S.3
  • 8
    • 69449098480 scopus 로고    scopus 로고
    • Effects of mesalamine (5-aminosalicylic acid) on bacterial gene expression
    • Kaufman J, Griffiths TA, Surette MG, et al. Effects of mesalamine (5-aminosalicylic acid) on bacterial gene expression. Inflamm Bowel Dis. 2009; 15: 985-996.
    • (2009) Inflamm Bowel Dis. , vol.15 , pp. 985-996
    • Kaufman, J.1    Griffiths, T.A.2    Surette, M.G.3
  • 9
    • 0029044783 scopus 로고
    • Rectal aminosalicylate therapy for distal ulcerative colitis: A meta-analysis
    • Marshall JK, Irvine EJ,. Rectal aminosalicylate therapy for distal ulcerative colitis: a meta-analysis. Aliment Pharmacol Ther. 1995; 9: 293-300.
    • (1995) Aliment Pharmacol Ther. , vol.9 , pp. 293-300
    • Marshall, J.K.1    Irvine, E.J.2
  • 10
    • 0034061366 scopus 로고    scopus 로고
    • A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis
    • Cohen RD, Woseth DM, Thisted RA, et al. A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis. Am J Gastroenterol. 2000; 95: 1263-1276.
    • (2000) Am J Gastroenterol. , vol.95 , pp. 1263-1276
    • Cohen, R.D.1    Woseth, D.M.2    Thisted, R.A.3
  • 11
    • 0033944708 scopus 로고    scopus 로고
    • Putting rectal 5-aminosalicylic acid in its place: The role in distal ulcerative colitis
    • Marshall JK, Irvine EJ,. Putting rectal 5-aminosalicylic acid in its place: the role in distal ulcerative colitis. Am J Gastroenterol. 2000; 95: 1628-1636.
    • (2000) Am J Gastroenterol. , vol.95 , pp. 1628-1636
    • Marshall, J.K.1    Irvine, E.J.2
  • 12
  • 13
    • 0027281895 scopus 로고
    • Metabolic activation and deactivation of arylamine carcinogens by recombinant human NAT1 and polymorphic NAT2 acetyltransferases
    • Hein DW, Doll MA, Rustan TD, et al. Metabolic activation and deactivation of arylamine carcinogens by recombinant human NAT1 and polymorphic NAT2 acetyltransferases. Carcinogenesis. 1993; 14: 1633-1638.
    • (1993) Carcinogenesis , vol.14 , pp. 1633-1638
    • Hein, D.W.1    Doll, M.A.2    Rustan, T.D.3
  • 14
    • 33644995445 scopus 로고    scopus 로고
    • Systematic review: Adherence issues in the treatment of ulcerative colitis
    • Kane SV,. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2006; 23: 577-585.
    • (2006) Aliment Pharmacol Ther. , vol.23 , pp. 577-585
    • Kane, S.V.1
  • 15
    • 18944363679 scopus 로고    scopus 로고
    • A new oral delivery system for 5-ASA: Preliminary clinical findings for MMX
    • Prantera C, Viscido A, Biancone L, et al. A new oral delivery system for 5-ASA: preliminary clinical findings for MMX. Inflamm Bowel Dis. 2005; 11: 421-427.
    • (2005) Inflamm Bowel Dis. , vol.11 , pp. 421-427
    • Prantera, C.1    Viscido, A.2    Biancone, L.3
  • 16
    • 33751574430 scopus 로고    scopus 로고
    • A practical perspective on ulcerative colitis: Patients' needs from aminosalicylate therapies
    • Loftus EV Jr,. A practical perspective on ulcerative colitis: patients' needs from aminosalicylate therapies. Inflamm Bowel Dis. 2006; 12: 1107-1113.
    • (2006) Inflamm Bowel Dis. , vol.12 , pp. 1107-1113
    • Loftus Jr., E.V.1
  • 17
    • 0030862269 scopus 로고    scopus 로고
    • Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis
    • Gionchetti P, Rizzello F, Venturi A, et al. Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis. Aliment Pharmacol Ther. 1997; 11: 1053-1057.
    • (1997) Aliment Pharmacol Ther. , vol.11 , pp. 1053-1057
    • Gionchetti, P.1    Rizzello, F.2    Venturi, A.3
  • 18
    • 0025322421 scopus 로고
    • Mesalazine (5-aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis. A randomized controlled trial
    • Campieri M, De Franchis R, Bianchi-Porro G, et al. Mesalazine (5-aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis. A randomized controlled trial. Scand J Gastroenterol. 1990; 25: 663-668.
    • (1990) Scand J Gastroenterol. , vol.25 , pp. 663-668
    • Campieri, M.1    De Franchis, R.2    Bianchi-Porro, G.3
  • 19
    • 0023221030 scopus 로고
    • 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis
    • Sutherland LR, Martin F, Greer S, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology. 1987; 92: 1894-1898.
    • (1987) Gastroenterology , vol.92 , pp. 1894-1898
    • Sutherland, L.R.1    Martin, F.2    Greer, S.3
  • 20
    • 0024587677 scopus 로고
    • Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: A randomised trial
    • Rachmilewitz D,. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ. 1989; 298: 82-86.
    • (1989) BMJ. , vol.298 , pp. 82-86
    • Rachmilewitz, D.1
  • 21
    • 0026065160 scopus 로고
    • Microscopic activity in ulcerative colitis: What does it mean?
    • Riley SA, Mani V, Goodman MJ, et al. Microscopic activity in ulcerative colitis: what does it mean? Gut. 1991; 32: 174-178.
    • (1991) Gut. , vol.32 , pp. 174-178
    • Riley, S.A.1    Mani, V.2    Goodman, M.J.3
  • 22
    • 0027292761 scopus 로고
    • Mesalamine capsules for treatment of active ulcerative colitis: Results of a controlled trial. Pentasa Study Group
    • Hanauer SB, Schwartz J, Robinson M, et al. Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Pentasa Study Group. Am J Gastroenterol. 1993; 88: 1188-1197.
    • (1993) Am J Gastroenterol. , vol.88 , pp. 1188-1197
    • Hanauer, S.B.1    Schwartz, J.2    Robinson, M.3
  • 23
    • 0035393497 scopus 로고    scopus 로고
    • Association of NAT1 and NAT2 polymorphisms to urinary bladder cancer: Significantly reduced risk in subjects with NAT1*10
    • Cascorbi I, Roots I, Brockmoller J,. Association of NAT1 and NAT2 polymorphisms to urinary bladder cancer: significantly reduced risk in subjects with NAT1*10. Cancer Res. 2001; 61: 5051-5056.
    • (2001) Cancer Res. , vol.61 , pp. 5051-5056
    • Cascorbi, I.1    Roots, I.2    Brockmoller, J.3
  • 24
    • 0035104031 scopus 로고    scopus 로고
    • Frequency of single nucleotide polymorphisms in the P-glycoprotein drug transporter MDR1 gene in white subjects
    • Cascorbi I, Gerloff T, Johne A, et al. Frequency of single nucleotide polymorphisms in the P-glycoprotein drug transporter MDR1 gene in white subjects. Clin Pharmacol Ther. 2001; 69: 169-174.
    • (2001) Clin Pharmacol Ther. , vol.69 , pp. 169-174
    • Cascorbi, I.1    Gerloff, T.2    Johne, A.3
  • 25
    • 0345240943 scopus 로고    scopus 로고
    • Correlation between genotype and phenotype of the human arylamine N-acetyltransferase type 1 (NAT1)
    • Bruhn C, Brockmöller J, Cascorbi I, et al. Correlation between genotype and phenotype of the human arylamine N-acetyltransferase type 1 (NAT1). Biochem Pharmacol. 1999; 58: 1759-1764.
    • (1999) Biochem Pharmacol. , vol.58 , pp. 1759-1764
    • Bruhn, C.1    Brockmöller, J.2    Cascorbi, I.3
  • 26
    • 0029163589 scopus 로고
    • Arylamine N-acetyltransferase (NAT2) mutations and their allelic linkage in unrelated Caucasian individuals: Correlation with phenotypic activity
    • Cascorbi I, Drakoulis N, Brockmöller J, et al. Arylamine N-acetyltransferase (NAT2) mutations and their allelic linkage in unrelated Caucasian individuals: correlation with phenotypic activity. Am J Hum Genet. 1995; 57: 581-592.
    • (1995) Am J Hum Genet. , vol.57 , pp. 581-592
    • Cascorbi, I.1    Drakoulis, N.2    Brockmöller, J.3
  • 27
    • 33749267293 scopus 로고    scopus 로고
    • Role of pharmacogenetics of ATP-binding cassette transporters in the pharmacokinetics of drugs
    • Cascorbi I,. Role of pharmacogenetics of ATP-binding cassette transporters in the pharmacokinetics of drugs. Pharmacol Ther. 2006; 112: 457-473.
    • (2006) Pharmacol Ther. , vol.112 , pp. 457-473
    • Cascorbi, I.1
  • 28
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien PC, Fleming TR,. A multiple testing procedure for clinical trials. Biometrics. 1979; 35: 549-556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 30
    • 0025633361 scopus 로고
    • Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk
    • Farrington CP, Manning G,. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990; 9: 1447-1454.
    • (1990) Stat Med. , vol.9 , pp. 1447-1454
    • Farrington, C.P.1    Manning, G.2
  • 31
    • 10744221150 scopus 로고    scopus 로고
    • Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis
    • Rutter M, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004; 126: 451-459.
    • (2004) Gastroenterology , vol.126 , pp. 451-459
    • Rutter, M.1    Saunders, B.2    Wilkinson, K.3
  • 32
    • 9344253340 scopus 로고    scopus 로고
    • Cancer surveillance in longstanding ulcerative colitis: Endoscopic appearances help predict cancer risk
    • Rutter MD, Saunders BP, Wilkinson KH, et al. Cancer surveillance in longstanding ulcerative colitis: endoscopic appearances help predict cancer risk. Gut. 2004; 53: 1813-1816.
    • (2004) Gut. , vol.53 , pp. 1813-1816
    • Rutter, M.D.1    Saunders, B.P.2    Wilkinson, K.H.3
  • 33
    • 0026492902 scopus 로고
    • Efficacy of a daily application of mesalazine (Pentasa) suppository with progressive release, in the treatment of ulcerative proctitis. A double-blind versus placebo randomized trial
    • Ngo Y, Gelinet JM, Ivanovic A, et al. [Efficacy of a daily application of mesalazine (Pentasa) suppository with progressive release, in the treatment of ulcerative proctitis. A double-blind versus placebo randomized trial.] Gastroenterol Clin Biol. 1992; 16: 782-786.
    • (1992) Gastroenterol Clin Biol. , vol.16 , pp. 782-786
    • Ngo, Y.1    Gelinet, J.M.2    Ivanovic, A.3
  • 34
    • 0030997075 scopus 로고    scopus 로고
    • Efficacy and tolerance of mesalazine suppositories vs. hydro-cortisone foam in proctitis
    • Lucidarme D, Marteau P, Foucault M, et al. Efficacy and tolerance of mesalazine suppositories vs. hydro-cortisone foam in proctitis. Aliment Pharmacol Ther. 1997; 11: 335-340.
    • (1997) Aliment Pharmacol Ther. , vol.11 , pp. 335-340
    • Lucidarme, D.1    Marteau, P.2    Foucault, M.3
  • 35
    • 0033987732 scopus 로고    scopus 로고
    • Comparative, open, randomized trial of the efficacy and tolerance of slow-release 5-ASA suppositories once daily versus conventional 5-ASA suppositories twice daily in the treatment of active cryptogenic proctitis
    • the French Pentasa Study Group.
    • Marteau P, Florent C, and the French Pentasa Study Group. Comparative, open, randomized trial of the efficacy and tolerance of slow-release 5-ASA suppositories once daily versus conventional 5-ASA suppositories twice daily in the treatment of active cryptogenic proctitis. Am J Gastroenterol. 2000; 95: 166-170.
    • (2000) Am J Gastroenterol. , vol.95 , pp. 166-170
    • Marteau, P.1    Florent, C.2
  • 36
    • 21844438005 scopus 로고    scopus 로고
    • Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: A multicenter randomized study
    • Lamet M, Ptak T, Dallaire C, et al. Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: a multicenter randomized study. Inflamm Bowel Dis. 2005; 11: 625-630.
    • (2005) Inflamm Bowel Dis. , vol.11 , pp. 625-630
    • Lamet, M.1    Ptak, T.2    Dallaire, C.3
  • 37
    • 34250375662 scopus 로고    scopus 로고
    • A clinical trial on absorption and N-Acetylation of oral and rectal mesalazine
    • Dilger K, Trenk D, Rössle M, et al. A clinical trial on absorption and N-Acetylation of oral and rectal mesalazine. Eur J Clin Invest. 2007; 37: 558-565.
    • (2007) Eur J Clin Invest. , vol.37 , pp. 558-565
    • Dilger, K.1    Trenk, D.2    Rössle, M.3
  • 38
    • 0025376146 scopus 로고
    • Topical treatment with 5-aminosalicylic in distal ulcerative colitis by using a new suppository preparation. A double-blind placebo controlled trial
    • Campieri M, Gionchetti P, Belluzzi A, et al. Topical treatment with 5-aminosalicylic in distal ulcerative colitis by using a new suppository preparation. A double-blind placebo controlled trial. Int J Colorectal Dis. 1990; 5: 79-81.
    • (1990) Int J Colorectal Dis. , vol.5 , pp. 79-81
    • Campieri, M.1    Gionchetti, P.2    Belluzzi, A.3
  • 39
    • 0842265246 scopus 로고    scopus 로고
    • Systematic review: Short-term adverse effects of 5-aminosalicylic acid agents in the treatment of ulcerative colitis
    • Loftus EV, Kane SV, Bjorkman D,. Systematic review: short-term adverse effects of 5-aminosalicylic acid agents in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2004; 19: 179-189.
    • (2004) Aliment Pharmacol Ther. , vol.19 , pp. 179-189
    • Loftus, E.V.1    Kane, S.V.2    Bjorkman, D.3
  • 40
    • 0028198167 scopus 로고
    • Expression of monomorphic and polymorphic N-acetyltransferases in human colon
    • Ilett KF, Ingram DM, Carpenter DS, et al. Expression of monomorphic and polymorphic N-acetyltransferases in human colon. Biochem Pharmacol. 1994; 47: 914-917.
    • (1994) Biochem Pharmacol. , vol.47 , pp. 914-917
    • Ilett, K.F.1    Ingram, D.M.2    Carpenter, D.S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.