title: Extended-release mesalamine granules for ulcerative colitis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of extended-release mesalamine granules in the maintenance of remission in ulcerative colitis (UC).
  
  
  METHODS
  Literature was obtained through searches of MEDLINE (1990-June 2012) using the terms mesalamine granules, ulcerative colitis, Apriso, and Salofalk. Bibliographies from retrieved articles were searched for additional citations.
  
  
  METHODS
  All English-language articles reporting on use of extended-release mesalamine granules in humans identified through the search were evaluated and included.
  
  
  RESULTS
  The preferred initial treatment for induction and maintenance of remission in mild to moderate UC is agents from the 5-aminosalicylate class (balsalazide, mesalamine, olsalazine, sulfasalazine). Mesalamine granules are available as an encapsulated product in the US and as a nonencapsulated formulation in Europe. Data evaluating encapsulated mesalamine granules for induction of remission are lacking; however, the European mesalamine granule formulation has been evaluated for induction of remission. Patients receiving mesalamine granules for induction achieved clinical and endoscopic remission more frequently than those receiving placebo. Two pivotal, randomized, double-blind, placebo-controlled, multicenter studies have evaluated encapsulated mesalamine granules for maintenance in 562 adults in remission from UC. In both studies, the proportion of patients who remained relapse-free at 6 months was higher for those receiving encapsulated mesalamine granules than placebo. Mesalamine granules are well tolerated, with headache, nausea, and upper respiratory infections being the most frequently reported adverse effects.
  
  
  CONCLUSIONS
  Current evidence supports the use of extended-release mesalamine granules for maintenance of remission in mild to moderate UC. Further studies are necessary to examine the ideal dose and regimen of encapsulated mesalamine granules for induction of remission in UC.
authors.affiliation: Department of Clinical Pharmacy and Outcomes Sciences, South Carolina College of Pharmacy-University of South Carolina Campus, Columbia, SC, USA. loveb@sccp.sc.edu
authors.forename: Bryan L
authors.initials: BL
authors.lastname: Love
authors.forename: April D
authors.initials: AD
authors.lastname: Miller
mesh_terms: D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000378:metabolism; D003692:Delayed-Action Preparations; D004347:Drug Interactions; D006801:Humans; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D019804:Mesalamine