Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis

Alimentary Pharmacology and Therapeutics

Volumn 46, Issue 3, 2017, Pages 292-302

  D'Haens, G R ^a   Sandborn, W J ^a   Zou, G ^a   Stitt, L W ^a   Rutgeerts, P J ^a   Gilgen, D ^a   Jairath, V ^a   Hindryckx, P ^a   Shackelton, L M ^a   Vandervoort, M K ^a   Parker, C E ^a   Muller, C ^a   Pai, R K ^a   Levchenko, O ^a   Marakhouski, Y ^a   Horynski, M ^a   Mikhailova, E ^a   Kharchenko, N ^a   Pimanov, S ^b   Feagan, B G ^a  

^a NONE   (Ukraine)

^b VITEBSK STATE MEDICAL UNIVERSITY   (Belarus)

Author keywords

[No Author keywords available]

Indexed keywords

MESALAZINE; PLACEBO; NONSTEROID ANTIINFLAMMATORY AGENT;

AGE; ARTICLE; CONTROLLED STUDY; DISEASE ACTIVITY; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; HUMAN; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MORNING DOSAGE; MULTICENTER STUDY; OPEN STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; TABLET; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; ADOLESCENT; ADULT; AGED; CLINICAL TRIAL; COMPARATIVE STUDY; FEMALE; MALE; MEDICINAL CHEMISTRY; MIDDLE AGED; ORAL DRUG ADMINISTRATION;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CHEMISTRY, PHARMACEUTICAL; COLITIS, ULCERATIVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MESALAMINE; MIDDLE AGED; REMISSION INDUCTION; TABLETS;

EID: 85019995284     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.14164     Document Type: Article

References (40)

1. Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015;148:1035-1058.
2. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012;6:991-1030.
3. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology. Practice Parameters Committee. Am J Gastroenterol. 2010;105:501-523.
4. Wang Y, Parker CE, Bhanji T, et al. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016;4:CD000543.
5. Wang Y, Parker CE, Feagan BG, et al. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016;5:CD000544.
6. Kane S, Huo D, Aikens J, et al. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003;114:39-43.
7. Shale MJ, Riley SA. Studies of compliance with delayed-release mesalazine therapy in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2003;18:191-198.
8. Lachaine J, Yen L, Beauchemin C, et al. Medication adherence and persistence in the treatment of Canadian ulcerative colitis patients: analyses with the RAMQ database. BMC Gastroenterol. 2013;13:23.
9. Kane SV, Sumner M, Solomon D, et al. Twelve-month persistency with oral 5-aminosalicylic acid therapy for ulcerative colitis: results from a large pharmacy prescriptions database. Dig Dis Sci. 2011;56:3463-3470.
10. Khan N, Abbas AM, Bazzano LA, et al. Long-term oral mesalazine adherence and the risk of disease flare in ulcerative colitis: nationwide 10-year retrospective cohort from the veterans affairs healthcare system. Aliment Pharmacol Ther. 2012;36:755-764.
11. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987;317:1625-1629.
12. Feagan BG, Sandborn WJ, D'Haens G, et al. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013;145:149-157.
13. Jairath V, Zou G, Parker CE, et al. Systematic review and meta-analysis: placebo rates in induction and maintenance trials of ulcerative colitis. J Crohns Colitis. 2016;10:607-618.
14. Geboes K, Riddell R, Ost A, et al. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000;47:404-409.
15. Mosli MH, Feagan BG, Zou G, et al. Development and validation of a histological index for UC. Gut. 2017;66:50-58.
16. US Food and Drug Administration (FDA). Guidance for Industry: Patient-Reported Outcome Measures use in Medical Product Development to Support Labeling Claims. Department of Health and Human Services (US) FaDA, Center for Drug Evaluation and Research (CDER), Rockville, MD: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf, 2009. Accessed August 21, 2016.
17. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473-483.
18. EuroQol Group. EuroQol–a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199-208.
19. Reilly MC, Gerlier L, Brabant Y, et al. Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease. Clin Ther. 2008;30:393-404.
20. Jairath V, Khanna R, Zou GY, et al. Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials. Aliment Pharmacol Ther. 2015;42:1200-1210.
21. Matilde Sanchez M, Chen X. Choosing the analysis population in non-inferiority studies: per protocol or intent-to-treat. Stat Med. 2006;25:1169-1181.
22. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998;17:873-890.
23. Smith DG, Clemens J, Crede W, et al. Impact of multiple comparisons in randomized clinical trials. Am J Med. 1987;83:545-550.
24. Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007;132:66-75.
25. Hosmer D, Lemesbow S. A goodness-of-fit test for the multiple logistic regression model. Commun Stat. 1980;A10:1043-1069.
26. Mosli MH, Feagan BG, Sandborn WJ, et al. Histologic evaluation of ulcerative colitis: a systematic review of disease activity indices. Inflamm Bowel Dis. 2014;20:564-575.
27. Lichtenstein GR, Kamm MA, Boddu P, et al. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007;5:95-102.
28. Levy RL, Feld AD. Increasing patient adherence to gastroenterology treatment and prevention regimens. Am J Gastroenterol. 1999;94:1733-1742.
29. Dignass AU, Bokemeyer B, Adamek H, et al. Mesalamine once daily is more effective than twice daily in patients with quiescent ulcerative colitis. Clin Gastroenterol Hepatol. 2009;7:762-769.
30. Flourie B, Hagege H, Tucat G, et al. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis. Aliment Pharmacol Ther. 2013;37:767-775.
31. Hawthorne AB, Stenson R, Gillespie D, et al. One-year investigator-blind randomized multicenter trial comparing Asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis. Inflamm Bowel Dis. 2012;18:1885-1893.
32. Kamm MA, Lichtenstein GR, Sandborn WJ, et al. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008;57:893-902.
33. Kane S, Holderman W, Jacques P, et al. Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: preliminary results from a randomized trial. Patient Prefer Adherence. 2008;2:253-258.
34. Kane S, Huo D, Magnanti K. A pilot feasibility study of once daily dosing versus conventional dosing mesalamine for maintenance of ulcerative colitis. Clin Gastroenterol Hepatol. 2003;1:170-173.
35. Kruis W, Jonaitis L, Pokrotnieks J, et al. Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. Aliment Pharmacol Ther. 2011;33:313-322.
36. Prantera C, Kohn A, Campieri M, et al. Clinical trial: ulcerative colitis maintenance treatment with 5-ASA: a 1-year, randomized multicentre study comparing MMX with Asacol. Aliment Pharmacol Ther. 2009;30:908-918.
37. Watanabe M, Hanai H, Nishino H, et al. Comparison of QD and TID oral mesalazine for maintenance of remission in quiescent ulcerative colitis: a double-blind, double-dummy, randomized multicenter study. Inflamm Bowel Dis. 2013;19:1681-1690.
38. Dalager T, Bredahl TG, Pedersen MT, et al. Does training frequency and supervision affect compliance, performance and muscular health? A cluster randomized controlled trial. Man Ther. 2015;20:657-665.
39. Fuller C, Michie S, Savage J, et al. The Feedback intervention trial (FIT)–improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial. PLoS ONE. 2012;7:e41617.
40. Lonsdale C, Hall AM, Williams GC, et al. Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods. BMC Musculoskelet Disord. 2012;13:104.