Chemoprevention of colonic polyps with balsalazide: An exploratory, double-blind, placebo-controlled study

Digestive Diseases and Sciences

Volumn 54, Issue 11, 2009, Pages 2488-2496

  Terdiman, Jonathan P ^a   Johnson, Lorin K ^b   Kim, Young S ^a,c   Sleisenger, Marvin H ^a,c   Gum, James R ^a,c   Hayes, Ann ^a,c   Weinberg, Vivian K ^d   McQuaid, Kenneth R ^a,c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Salix a Division of Valeant Pharmaceuticals North America LLC   (United States)

^c SAN FRANCISCO VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

5 Aminosalicylic acid; Balsalazide; Chemoprevention; Colonic adenoma; Colonic polyp; Colorectal cancer

Indexed keywords

BALSALAZIDE; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COLON ADENOMA; COLON POLYP; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG WITHDRAWAL; ENDOSCOPY; EXPLORATORY RESEARCH; FOLLOW UP; HISTOLOGY; HUMAN; MAJOR CLINICAL STUDY; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIGMOID; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ADENOMA; AGED; APOPTOSIS; COLON, SIGMOID; COLONIC NEOPLASMS; COLONIC POLYPS; DOUBLE-BLIND METHOD; GASTROINTESTINAL AGENTS; HUMANS; MALE; MESALAMINE; MIDDLE AGED; PHENYLHYDRAZINES; PROSPECTIVE STUDIES;

EID: 70350231915     PISSN: 01632116     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10620-009-0966-2     Document Type: Article

References (34)

1. JM Walsh JP Terdiman 2003 Colorectal cancer screening: scientific review JAMA 289 1288 1296 10.1001/jama.289.10.1288 12633191 (Pubitemid 37432910)
2. JH Bond 2000 Colorectal cancer update. Prevention, screening, treatment, and surveillance for high-risk groups Med Clin North Am 84 1163 1182 10.1016/S0025-7125(05)70281-9 1:STN:280:DC%2BD3cvns1ymsQ%3D%3D 11026923
3. A Jemal R Siegel E Ward T Murray J Xu MJ Thun 2007 Cancer statistics, 2007 CA Cancer J Clin 57 43 66 10.3322/canjclin.57.1.43 17237035
4. SJ Winawer AG Zauber RH Fletcher JS Stillman MJ O'brien B Levin RA Smith DA Lieberman RW Burt TR Levin JH Bond D Brooks T Byers N Hyman L Kirk A Thorson C Simmang D Johnson DK Rex 2006 Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US multi-society task force on colorectal cancer and the American cancer society CA Cancer J Clin 56 143 159 10.3322/canjclin.56.3.143 16737947 (Pubitemid 43847925)
5. JH Bond 2000 Polyp guideline: diagnosis, treatment, and surveillance for patients with colorectal polyps Am J Gastroenterol 95 3053 3063 10.1111/j.1572-0241.2000.03434.x 1:STN:280:DC%2BD3M%2FnsFGqsA%3D%3D 11095318 For the practice parameters committee of the American college of gastroenterology
6. WS Atkin BC Morson J Cuzick 1992 Long-term risk of colorectal cancer after excision of rectosigmoid adenomas N Engl J Med 326 658 662 1:STN:280:DyaK387ktVClsw%3D%3D 1736104
7. SJ Winawer 2007 Colorectal cancer screening Best Pract Res Clin Gastroenterol 21 1031 1048 10.1016/j.bpg.2007.09.004 18070702 (Pubitemid 350215368)
8. C Dubé A Rostom G Lewin A Tsertsvadze N Barrowman C Code M Sampson D Moher 2007 The use of aspirin for primary prevention of colorectal cancer: a systematic review prepared for the US preventive services task force Ann Intern Med 146 365 375 17339622
9. K Krishnan DE Brenner 1996 Chemoprevention of colorectal cancer Gastroenterol Clin North Am 25 821 858 10.1016/S0889-8553(05)70277-6 1:STN:280:DyaK2s7itVahtg%3D%3D 8960895 (Pubitemid 27022918)
10. CN Bernstein J Eaden AH Steinhart P Munkholm PH Gordon 2002 Cancer prevention in inflammatory bowel disease and the chemoprophylactic potential of 5-aminosalicylic acid Inflamm Bowel Dis 8 356 361 10.1097/00054725-200209000- 00007 12479651
11. ET Hawk A Umar JL Viner 2004 Colorectal cancer chemoprevention-an overview of the science Gastroenterology 126 1423 1447 10.1053/j.gastro.2004.03. 002 15131803 (Pubitemid 38552806)
12. A Rostom C Dubé G Lewin A Tsertsvadze N Barrowman C Code M Sampson D Moher 2007 Nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors for primary prevention of colorectal cancer: a systematic review prepared for the US preventive services task force Ann Intern Med 146 376 389 17339623
13. JA Eaden KR Abrams JF Mayberry 2001 The risk of colorectal cancer in ulcerative colitis: a meta-analysis Gut 48 526 535 10.1136/gut.48.4.526 1:STN:280:DC%2BD3M3hs1Orsw%3D%3D 11247898 (Pubitemid 32234798)
14. JP Terdiman M Steinbuch WA Blumentals TA Ullman DT Rubin 2007 5-Aminosalicylic acid therapy and the risk of colorectal cancer among patients with inflammatory bowel disease Inflamm Bowel Dis 13 367 371 10.1002/ibd.20074 17206695 (Pubitemid 46668239)
15. FS Velayos JP Terdiman JM Walsh 2005 Effect of 5-aminosalicylate use on colorectal cancer and dysplasia risk: a systematic review and metaanalysis of observational studies Am J Gastroenterol 100 1345 1353 10.1111/j.1572-0241.2005. 41442.x 1:CAS:528:DC%2BD2MXmtFarsL4%3D 15929768 (Pubitemid 40904360)
16. CN Bernstein JF Blanchard C Metge M Yogendran 2003 Does the use of 5-aminosalicylates in inflammatory bowel disease prevent the development of colorectal cancer? Am J Gastroenterol 98 2784 2788 10.1111/j.1572-0241.2003. 08718.x 1:CAS:528:DC%2BD3sXpvVahsLg%3D 14687833 (Pubitemid 38020124)
17. BM Ryan MGVM Russel E Langholz RW Stockbrugger 2003 Aminosalicylates and colorectal cancer in IBD: a not-so bitter pill to swallow Am J Gastroenterol 98 1682 1687 10.1111/j.1572-0241.2003.07599.x 1:CAS:528:DC%2BD3sXlvFGkurw%3D 12907319 (Pubitemid 36959145)
18. J Eaden 2003 Review article: the data supporting a role for aminosalicylates in the chemoprevention of colorectal cancer in patients with inflammatory bowel disease Aliment Pharmacol Ther 18 Suppl 2 15 21 10.1046/j.1365-2036.18.s2.3.x 1:CAS:528:DC%2BD3sXot1Cntr4%3D 12950416
19. J Eaden K Abrams A Ekbom E Jackson J Mayberry 2000 Colorectal cancer prevention in ulcerative colitis: a case-control study Aliment Pharmacol Ther 14 145 153 10.1046/j.1365-2036.2000.00698.x 1:STN:280:DC%2BD3c7hsleqsg%3D%3D 10651654 (Pubitemid 30088290)
20. TP van Staa T Card RF Logan HG Leufkens 2005 5-Aminosalicylate use and colorectal cancer risk in inflammatory bowel disease: a large epidemiological study Gut 54 1573 1578 10.1136/gut.2005.070896 15994215 (Pubitemid 41531774)
21. PJ Bus ID Nagtegaal HW Verspaget CB Lamers H Geldof JH Van Krieken G Griffioen 1999 Mesalazine-induced apoptosis of colorectal cancer: on the verge of a new chemopreventive era? Aliment Pharmacol Ther 13 1397 1402 10.1046/j.1365-2036.1999.00652.x 1:CAS:528:DyaK1MXnvVKms7g%3D 10571594 (Pubitemid 29516250)
22. MG Luciani C Campregher JM Fortune TA Kunkel C Gasche 2007 5-ASA affects cell cycle progression in colorectal cells by reversibly activating a replication checkpoint Gastroenterology 132 221 235 10.1053/j.gastro.2006.10.016 1:CAS:528:DC%2BD2sXit1aqsbs%3D 17241873 (Pubitemid 46108738)
23. JRB Green AJ Lobo CD Holdsworth RJ Leicester JA Gibson GD Kerr HJ Hodgson KJ Parkins MD Taylor 1998 Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis Gastroenterology 114 15 22 10.1016/S0016-5085(98)70627-4 1:CAS:528:DyaK1cXksFyrtA%3D%3D 9428213 (Pubitemid 28020949)
24. DS Levine DS Riff R Pruitt L Wruble G Koval D Sales JK Bell LK Johnson 2002 A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis Am J Gastroenterol 97 1398 1407 1:CAS:528:DC%2BD2MXjtFOnsbw%3D 12094857
25. JRB Green JA Gibson GD Kerr ET Swarbrick AJ Lobo CD Holdsworth 1998 Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months Aliment Pharmacol Ther 12 1207 1216 10.1046/j.1365-2036.1998.00427.x 1:CAS:528:DyaK1MXlvV2ksg%3D%3D 9882028
26. JRB Green CHJ Swan JA Gibson GD Kerr ET Swarbrick PC Thornton 2004 Patient-led variable dosing with balsalazide as long-term therapy for maintenance in ulcerative colitis: a 3-year prospective observational study Aliment Pharmacol Ther 19 435 442 10.1111/j.1365-2036.2004.01866.x 1:CAS:528:DC%2BD2cXis1Sgtro%3D 14871283 (Pubitemid 38297112)
27. DJ MacGregor YS Kim MH Sleisenger LK Johnson 2000 Chemoprevention of colon cancer carcinogenesis by balsalazide: inhibition of azoxymethane-induced aberrant crypt formation in the rat colon and intestinal tumor formation in the B6-Min/+ mouse Int J Oncol 17 173 179 1:CAS:528:DC%2BD3cXksV2qsro%3D 10853036
28. Y Gavrieli Y Sherman SA Ben-Sasson 1992 Identification of programmed cell death in situ via specific labeling of nuclear DNA fragmentation J Cell Biol 119 493 501 10.1083/jcb.119.3.493 1:CAS:528:DyaK38XmtVyhsbs%3D 1400587
29. DT Rubin MR Cruz-Correa C Gasche JR Jass GR Lichtenstein EA Montgomery RH Riddell MD Rutter TA Ullman FS Velayos S Itzkowitz 2008 Prevention meeting group: colorectal cancer prevention in inflammatory bowel disease and the role of 5-aminosalicylic acid: a clinical review and update Inflamm Bowel Dis 14 265 274 10.1002/ibd.20297 17932965 (Pubitemid 351288050)
30. FM Giardiello SR Hamilton AJ Krush S Piantadosi LM Hylind P Celano SV Booker CR Robinson GJ Offerhaus 1993 Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis N Engl J Med 328 1313 1316 10.1056/NEJM199305063281805 1:STN:280:DyaK3s3is1Sjtg%3D%3D 8385741 (Pubitemid 23131373)
31. G Steinbach PM Lynch RK Phillips MH Wallace E Hawk GB Gordon N Wakabayashi B Saunders Y Shen T Fujimura LK Su B Levin 2000 The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis N Engl J Med 342 1946 1952 10.1056/NEJM200006293422603 1:CAS:528: DC%2BD3cXltVCnu7Y%3D 10874062 (Pubitemid 30419089)
32. C Rousseaux B Lefebvre L Dubuquoy P Lefebvre O Romano J Auwerx D Metzger W Wahli B Desvergne GC Naccari P Chavatte A Farce P Bulois A Cortot JF Colombel P Desreumaux 2005 Intestinal antiinflammatory effect of 5-aminosalicylic acid is dependent on peroxisome proliferator-activated receptor-g J Exp Med 201 1205 1215 10.1084/jem.20041948 1:CAS:528:DC%2BD2MXjs1CitLg%3D 15824083 (Pubitemid 40629065)
33. C Gasche A Goel L Natarajan CR Boland 2005 Mesalazine improves replication fidelity in cultured colorectal cells Cancer Res 65 3993 3997 10.1158/0008-5472.CAN-04-3824 1:CAS:528:DC%2BD2MXktlSmsL8%3D 15899787 (Pubitemid 40775634)
34. M Fukata A Chen AS Vamadevan J Cohen K Breglio S Krishnareddy D Hsu R Xu N Harpaz AJ Dannenberg K Subbaramaiah HS Cooper SH Itzkowitz MT Abreu 2007 Toll-like receptor-4 promotes the development of colitis-associated colorectal tumors Gastroenterology 133 1869 1881 10.1053/j.gastro.2007.09.008 1:CAS:528:DC%2BD1cXnt1KqtA%3D%3D 18054559 (Pubitemid 350186162)