A randomized controlled study of mesalamine after acute diverticulitis: Results of the DIVA trial

Journal of Clinical Gastroenterology

Volumn 47, Issue 7, 2013, Pages 621-629

  Stollman, Neil ^a,b   Magowan, Simon ^c   Shanahan, Fergus ^d   Quigley, Eamonn M M ^d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Summitt Medical Center   (United States)

^c PROCTER AND GAMBLE COMPANY   (United States)

^d UNIVERSITY COLLEGE CORK   (Ireland)

Author keywords

antiinflammatory; diverticular disease; diverticulitis; mesalamine

Indexed keywords

ALIGN; MESALAZINE; PLACEBO; PROBIOTIC AGENT; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ABDOMINAL TENDERNESS; ACUTE DIVERTICULITIS; ADULT; AGED; ARTICLE; BIFIDOBACTERIUM LONGUM INFANTIS; BLOATING; CLOSTRIDIUM DIFFICILE; COMPUTER ASSISTED TOMOGRAPHY; CONSTIPATION; CONTROLLED STUDY; DEFECATION URGENCY; DIARRHEA; DIVERTICULITIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG WITHDRAWAL; DYSURIA; FEMALE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; MUCUS; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; SCORING SYSTEM; SYMPTOM; TREATMENT RESPONSE; VOMITING;

ACUTE DISEASE; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BIFIDOBACTERIUM; COLONIC DISEASES; DIVERTICULITIS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MESALAMINE; MIDDLE AGED; PROBIOTICS; RECURRENCE; SEVERITY OF ILLNESS INDEX; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME; UNITED STATES;

EID: 84880751655     PISSN: 01920790     EISSN: 15392031     Source Type: Journal    
DOI: 10.1097/MCG.0b013e31828003f6     Document Type: Article

References (53)

1. Petruzziello L, Iacopini F, Bulajic M, et al. Review article: uncomplicated diverticular disease of the colon. Aliment Parmacol Ther. 2006;23:1379-1391.
2. Delvaux M. Diverticular disease of the colon in Europe: epidemiology, impact on citizen health and prevention. Aliment Pharmacol Ther. 2003;18(suppl 3):71-74.
3. Kang JY, Hoare J, Tinto A, et al. Diverticular disease of the colon-on the rise: a study of hospital admissions in England between 1989/1990 and 1999/2000. Aliment Pharmacol Ther. 2003;17:1189-1195.
4. Schwesinger WH, Page CP, Gaskill HV III, et al. Operative management of diverticular emergencies: strategies and outcomes. Arch Surg. 2000;135:558-562; discussion 562-563.
5. Makela J, Kiviniemi H, Laitinen S. Prevalence of perforated sigmoid diverticulitis is increasing. Dis Colon Rectum. 2002;45:955-961.
6. Warner E, Crighton EJ, Moineddin R, et al. Fourteen-year study of hospital admissions for diverticular disease in Ontario. Can J Gastroenterol. 2007;21:97-99.
7. Simpson J, Scholefield JH, Spiller RC. Origin of symptoms in diverticular disease. Br J Surg. 2003;90:899-908.
8. Parks TG. Natural history of diverticular disease of the colon. Clin Gastroenterol. 1975;4:53-69.
9. Roberts P, Abel M, Rosen L, et al. Practice parameters for sigmoid diverticulitis: the Standards Task Force American Society of Colon and Rectal Surgeons. Dis Colon Rectum. 1995;38: 125-132.
10. Nathan BN. Who first described colonic diverticula? Can J Surg. 1991;34:203.
11. Parks TG. Natural history of diverticular disease of the colon: a review of 521 cases. BMJ. 1969;4:639-642.
12. Stollman NH, Raskin JB, for and on behalf of the Ad Hoc Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines. Diagnosis and management of diverticular disease of the colon in adults. Am J Gastroenterol. 1999;94:3110-3121.
13. Rafferty J, Shellito P, Hyman NH, et al. and the Standards Committee of the American Society of Colon and Rectal Surgeons. Practice parameters for sigmoid diverticulitis. Dis Colon Rectum. 2006;49:939-944.
14. Tursi A, Brandimarte G, Giorgetti GM, et al. Balsalazide and/or high potency probiotic mixture (VSL#3) in maintaining remission after attack of acute, uncomplicated diverticulitis of the colon. Int J Colorectal Dis. 2007;22:103-108.
15. Tursi A, Brandimarte G, Giorgetti GM, et al. Mesalazine and/or Lactobacillus casei in preventing recurrence of symptomatic uncomplicated diverticular disease of the colon. J Clin Gastroenterol. 2006;40:312-316.
16. DiMario F, Aragona G, Leandro G, et al. Efficacy of mesalamine in the treatment of symptomatic diverticular disease. Dig Dis Sci. 2005;50:581-586.
17. Chinn BT. Efficacy of mesalamine in diverticulitis. Am J Gastroenterol. 2005;100:S389.
18. Brandimarte G, Tursi A. Rifaximin plus mesalazine followed by mesalazine alone is highly effective in obtaining remission of symptomatic uncomplicated diverticular disease. Med Sci Monit. 2004;10:170-173.
19. Fric P, Zavoral M. The effect of non-pathogenic Escherichia coli in symptomatic uncomplicated diverticular disease of the colon. Eur J Gastroenterol Hepatol. 2003;15:313-315.
20. Tursi A, Brandimarte G, Daffina R. Long-term treatment with mesalamine and rifaximin versus rifaximin alone for patients with recurrent attacks of acute diverticulitis of colon. Dig Liver Dis. 2002;34:510-515.
21. Giaccari S, Tronci S, Falconieri M, et al. Long-term treatment with rifaximin and lactobacilli in post-diverticulitic stenoses of the colon. Riv Eur Med Sci Farmacol. 1993;15:29-34.
22. Tursi A. Acute diverticulitis of the colon-current medical therapeutic management. Expert Opin Pharmacother. 2004;5: 55-59.
23. Comparato G, Fanigliulo L, Cavallaro LG, et al. Prevention of complications and symptomatic recurrences in diverticular disease with mesalazine: a 12-month follow-up. Dig Dis Sci. 2007;52:2934-2941.
24. O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005;128:541-551.
25. Everhart JE. The burden of digestive diseases in the United States. NIH Publication No. 09-6433. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC; Bethesda, MD: US Government Printing Office; National Institute of Diabetes and Digestive and Kidney Diseases; 2008:107-110.
26. Sandler RS, Everhart JE, Donowitz M, et al. The burden of selected digestive diseases in the United States. Gastroenterology. 2002;122:1500-1511.
27. Whiteway J, Morson BC. Elastosis in diverticular disease of the sigmoid colon. Gut. 1985;26:258-276.
28. Bode MK, Karttunen TJ, Makela J, et al. Type I and III collagens in human colon cancer and diverticulosis. Scand J Gastroenterol. 2000;35:747-752.
29. Mimura T, Bateman AC, Lee RL, et al. Up-regulation of collagen and tissue inhibitors of matrix metalloproteinase in colonic diverticular disease. Dis Colon Rectum. 2004;47: 371-378.
30. Rosemar A, Ivarsson ML, Borjesson L, et al. Increased concentration of tissue-degrading matrix metalloproteinases and their inhibitor in complicated diverticular disease. Scand J Gastroenterol. 2007;42:215-220.
31. Arfwidsson S, Knock NG, Lehmann L, et al. Pathogenesis of multiple diverticula of the sigmoid colon in diverticular disease. Acta Chir Scand. 1964;63:1-68.
32. Painter NS. The aetiology of diverticulosis of the colon with special reference to the action of certain drugs on the behaviour of the colon. Ann R Coll Surg Engl. 1964;34:98-119.
33. Painter NS, Truelove SC, Ardran GM, et al. Segmentation and the localization of intraluminal pressures in the human colon, with special reference to the pathogenesis of colonic diverticula. Gastroenterology. 1965;49:169-177.
34. Trotman IF, Misiewicz JJ. Sigmoid motility in diverticular disease and the irritable bowel syndrome. Gut. 1988;29: 218-222.
35. Cortesini C, Pantalone D. Usefulness of colonic motility study in identifying patients at risk for complicated diverticular disease. Dis Colon Rectum. 1991;34:339-342.
36. Bassotti G, Battaglia E, Spinozzi F, et al. Twenty-four hour recordings of colonic motility in patients with diverticular disease: Evidence for abnormal motility and propulsive activity. Dis Colon Rectum. 2001;44:1814-1820.
37. Sugihara K, Muto T, Morioka Y. Motility study in right-sided diverticular disease of the colon. Gut. 1983;24:1130-1134.
38. Stollman N, Raskin JB. Diverticular disease of the colon. Lancet. 2004;363:631-639.
39. Painter NS, Burkitt DP. Diverticular disease of the colon: a deficiency disease of Western civilization. BMJ. 1971;2: 450-454.
40. Tursi A, Papagrigoriadis S. The current and evolving treatment of colonic diverticular disease. Aliment Pharmacol Ther. 2009; 30:532-546.
41. Aldoori WH, Giovannucci EL, Rimm EB, et al. A prospective study of diet and the risk of symptomatic diverticular disease in men. Am J Clin Nutr. 1994;60:757-764.
42. Aldoori WH, Giovannucci EL, Rockett HR, et al. A prospective study of dietary fiber types and symptomatic diverticular disease in men. J Nutr. 1998;128:714-719.
43. Berman LG, Burdick D, Heitzman ER, et al. A critical reappraisal of sigmoid peridiverticulitis. Surg Gynecol Obstet. 1968;127:481-491.
44. Schoetz DJ Jr. Uncomplicated diverticulitis: Indications for surgery and surgical management. Surg Clin North Am. 1993;73:965-974.
45. Chapman JR, Dozois EJ, Wolff BG, et al. Diverticulitis: a progressive disease? Do multiple recurrences predict less favorable outcomes? Ann Surg. 2006;243:876-880.
46. Tursi A, Joseph RE, Streck P. Expanding applications: the potential usage of 5-aminosalicylic acid in diverticular disease. Dig Dis Sci. 2011;56:3112-3121.
47. White J. Probiotics and their use in diverticulitis. J Clin Gastroenterol. 2006;40:S160-162.
48. Papi C, Ciaco A, Koch M, et al. Efficacy of rifaximin in the treatment of symptomatic diverticular disease of the colon. A multicentre double-blind placebo-controlled trial. Aliment Pharmacol Ther. 1995;9:33-39.
49. Colecchia A, Vestito A, Pasqui F, et al. Efficacy of long term cyclic administration of the poorly absorbed antibiotic rifaximin in symptomatic, uncomplicated colonic diverticular disease. World J Gastroenterol. 2007;13:264-269.
50. A phase III, randomised, double-blind, dose-response, stratified, placebo-controlled study evaluating the safety and efficacy of SPD476 versus placebo over 104 weeks in the prevention of recurrence of diverticulitis. Shire Pharmaceuticals. Clinicaltrial.gov identifier: NCT00545103.
51. A phase III, randomised, double-blind, dose-response, stratified, placebo-controlled study evaluating the safety and efficacy of SPD476 versus placebo over 104 weeks in the prevention of recurrence of diverticulitis. Shire Pharmaceuticals. Clinicaltrial.gov identifier: NCT00545740.
52. Double-blind, randomized, placebo-controlled, parallel group, multi-centre Phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis. Dr. Falk Pharma GmbH. Clinicaltrial.gov identifier: NCT00695643.
53. Double-blind, dose-response, randomised, placebo-controlled, parallel group, multi-centre Phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis. Dr. Falk Pharma GmbH. Clinicaltrial.gov identifier: NCT01038739.