Once-daily mesalamine granules for ulcerative colitis

Expert Review of Clinical Immunology

Volumn 6, Issue 4, 2010, Pages 521-526

  Lawlor, Garrett ^a   Ahmed, Awais ^a   Moss, Alan C ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

adherence; granules; mesalamine; remission; ulcerative colitis

Indexed keywords

APRISO; MESALAZINE; PLACEBO; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; CLINICAL TRIAL; DIARRHEA; DRUG CAPSULE; DRUG EFFICACY; DRUG FATALITY; DRUG MECHANISM; DRUG RELEASE; DRUG SAFETY; DRUG WITHDRAWAL; HEADACHE; HEARING IMPAIRMENT; HEMOLYTIC ANEMIA; HUMAN; INTERSTITIAL NEPHRITIS; LIVER FAILURE; PANCREATITIS; PNEUMONIA; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT;

ABDOMINAL PAIN; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CLINICAL TRIALS AS TOPIC; COLITIS, ULCERATIVE; DELAYED-ACTION PREPARATIONS; DIARRHEA; DRUG ADMINISTRATION SCHEDULE; HEADACHE; HUMANS; MESALAMINE; METABOLIC CLEARANCE RATE; TREATMENT OUTCOME;

EID: 77954401346     PISSN: 1744666X     EISSN: None     Source Type: Journal    
DOI: 10.1586/eci.10.22     Document Type: Review

References (34)

1. Loftus EV Jr. Clinical epidemiology of infammatory bowel disease: Incidence, prevalence, and environmental infuences. Gastroenterology 126(6), 1504-1517 (2004).
2. Svartz N. The treatment of 124 cases of ulcerative colitis with salazopyrine and attempts of desensibilization in cases of hypersensitiveness to sulfa. Acta Med. Scand. 131(Suppl. 206), 465-472 (1948).
3. Svartz N. Treatment of ulcerative colitis with salazopyrin. Int. Surg. 50(5), 421-427 (1968).
4. Das KM, Eastwood MA, McManus JP, Sircus W. Adverse reactions during salicylazosulfapyridine therapy and the relation with drug metabolism and acetylator phenotype. N. Engl. J. Med. 289(10), 491-495 (1973).
5. Azad Khan AK, Piris J, Truelove SC. An experiment to determine the active therapeutic moiety of sulphasalazine. Lancet 2(8044), 892-895 (1977). (Pubitemid 8222894)
6. Fernandez-Becker NQ, Moss AC. Improving delivery of aminosalicylates in ulcerative colitis: effect on patient outcomes. Drugs 68(8), 1089-1103 (2008).
7. Brunner M, Greinwald R, Kletter K et al. Gastrointestinal transit and release of 5-aminosalicylic acid from 153Sm-labelled mesalazine pellets vs. tablets in male healthy volunteers. Aliment. Pharmacol. Ther. 17(9), 1163-1169 (2003). (Pubitemid 36605753)
8. Brunner M, Assandri R, Kletter K et al. Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation. Aliment. Pharmacol. Ther. 17(3), 395-402 (2003). (Pubitemid 36259402)
9. Safdi A, Pieniaszek H, Grigston A, Forbes W. Multiple dose pharmacokinetics of granulated mesalamine, a unique formulation providing delayed and extended release of 5-ASA. Am. J. Gastroenterol. 103(A1126), S439 (2008).
10. Wiersma H, Escher JC, Dilger K et al. Pharmacokinetics of mesalazine pellets in children with infammatory bowel disease. Infamm. Bowel Dis. 10(5), 626-631 (2004). (Pubitemid 39276472)
11. Wilding IR, Behrens C, Tardif SJ, Wray H, Bias P, Albrecht W. Combined scintigraphic and pharmacokinetic investigation of enteric-coated mesalazine micropellets in healthy subjects. Aliment. Pharmacol. Ther. 17(9), 1153-1162 (2003). (Pubitemid 36605752)
12. Desreumaux P, Ghosh S. Review article: mode of action and delivery of 5-aminosalicylic acid-new evidence. Aliment. Pharmacol. Ther. 24(Suppl. 1), 2-9 (2006). (Pubitemid 44267773)
13. Dubuquoy L, Rousseaux C, Thuru X et al. PPARg as a new therapeutic target in infammatory bowel diseases. Gut 55(9), 1341-1349 (2006). (Pubitemid 44277368)
14. Rousseaux C, Lefebvre B, Dubuquoy L et al. Intestinal antiinfammatory effect of 5-aminosalicylic acid is dependent on peroxisome proliferator- activated receptor-g. J. Exp. Med. 201(8), 1205-1215 (2005). (Pubitemid 40629065)
15. Sandborn WJ, Hanauer SB. Systematic review: the pharmacokinetic profles of oral mesalazine formulations and mesalazine pro-drugs used in the management of ulcerative colitis. Aliment. Pharmacol. Ther. 17(1), 29-42 (2003).
16. Safdi A, Pieniaszek H, Grigston A, Forbes W. Minimal effect of a high-fat meal on the pharmacokinetics of once-daily, granulated mesalazine. Am. J. Gastroenterol. 103(A1127), S440 (2008).
17. Zakko S, Gordon GL, Murthy U et al. Once-daily mesalamine granules effectively maintain remission from ulcerative colitis: data from two Phase 3 trials. Gastroenterology 136(5), 252, T1202 (2009).
18. Sutherland LR, Martin F, Greer S et al. 5-aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 92(6), 1894-1898 (1987). (Pubitemid 17072238)
19. Lichtenstein GR. Once-daily 1.5g granulated mesalamine effectively maintains remission in patients with ulcerative colitis who switch from different 5-ASA formulations. Am. J. Gastroenterol. 103(S1), 429-430 (2008).
20. Lichtenstein G, Merchant K, Shaw A, Yuan J, Bortey E, Forbes W. Effcacy of mesalamine granules for maintenance of remission in patients recently treated with corticosteroids. Gastroenterology 136(5,Suppl. 1), T1204 (2009).
21. Kruis W, Bar-Meir S, Feher J et al. The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-fnding study with newly developed mesalamine. Clin. Gastroenterol. Hepatol. 1(1), 36-43 (2003). (Pubitemid 37254470)
22. Marakhouski Y, Fixa B, Holoman J et al. A double-blind dose-escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative colitis. Aliment. Pharmacol. Ther. 21(2), 133-140 (2005). (Pubitemid 40227447)
23. Kruis W, Kiudelis G, Racz I et al. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double dummy, randomised, non-inferiority trial. Gut 58(2), 233-240 (2009).
24. Zakko S, Murthy U, Pruitt R et al. Safety profle of once daily 1.5 g granulated mesalamine as maintenance therapy for mild-to-moderate ulcerative colitis: results from 2 Phase 3 trials. Am. J. Gastroenterol. 103(S437), 1119 (2008).
25. Gordon G, Zakko S, Murthy U et al. Long-term safety of once-daily 1.5 g mesalamine granules in patients in remission from ulcerative colitis. Gastroenterology 136(5, Suppl. 1), A521 (T1200) (2009).
26. Moss AC, Peppercorn MA. The risks and the benefts of mesalazine as a treatment for ulcerative colitis. Expert Opin. Drug Saf. 6(2), 99-107 (2007). (Pubitemid 46380804)
27. Arend LJ, Springate JE. Interstitial nephritis from mesalazine: case report and literature review. Pediatr. Nephrol. 19(5), 550-553 (2004). (Pubitemid 38594297)
28. Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am. J. Med. 114(1), 39-43 (2003). (Pubitemid 36126514)
29. Kane S, Shaya F. Medication non-adherence is associated with increased medical health care costs. Dig. Dis. Sci. 53(4), 1020-1024 (2008). (Pubitemid 351379831)
30. Kane S. A 38-year-old with recurrent colitis. Is it noncompliance? Clin. Gastroenterol. Hepatol. 7(11), 1164-1167 (2009).
31. 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. 7(7), 762-769 (2009).
32. Sandborn WJ, Korzenik J, Lashner B et al. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology 138(4), 1286-1296 (2010).
33. Ito H, Iida M, Matsumoto T et al. Direct comparison of two different mesalamine formulations for the maintenance of remission in patients with ulcerative colitis: a double-blind, randomized study. Infamm. Bowel Dis. DOI: 10.1002/ibd.21194 (2010) (Epub ahead of print).
34. Kruis W, Jonaitis L, Pokrotnieks J et al. Once daily 3 g mesalamine is the optimal dose for maintaining clinical remission in ulcerative colitis: a double-blind, double-dummy, randomized, controlled, dose-ranging study. Gastroenterology 134(4, Suppl. 1, T1124), A-489 (2008).