3 42.3 61.1 54.5 23.1 Non-adherers 10.5 58.3 55.5 40.0 66.7 P 0.008 0.358 0.551 0.500 0.095 SD SILVA SANCHEZ,1 H WAN,2 P STRECK,2 D WILLSHIRE,3 JB RASKIN4 1Shire, Brussels, Belgium, 2Shire, Wayne, PA, USA, 3Shire, North Ryde, Australia, 4University of Miami Health System, Miami, FL, USA Introduction: Multimatrix mesalazine is an oral, once-daily, 5-aminosalicylic acid formulation indicated for induction and maintenance of remission of mild-to-moderate ulcerative colitis (UC), and has also been studied for selleckchem the prevention of recurrent diverticulitis (DV). This analysis examines long-term pooled safety data from several clinical trials, including data from long-term use of high-dose (4.8 g)

multimatrix mesalazine. Methods: Safety Selleck Gefitinib data were pooled from 2 phase 3 (NCT00151944, NCT00151892) and 2 phase 4 trials (NCT00446849, NCT01124149) evaluating multimatrix mesalazine for maintenance of UC remission, and 2 phase 3 trials (NCT00545740, NCT00545103) assessing multimatrix mesalazine for prevention of recurrent DV. In the UC trials, patients were administered maintenance therapy with 2.4 g/day multimatrix mesalazine for 6 or 12 months; eligibility was based upon having quiescent UC symptoms (symptom scores of 0 for rectal bleeding and bowel movements), or

being in partial or complete remission (some combination of qualifying endoscopy and Ribonucleotide reductase symptom scores). In the DV trials, patients with a history of acute DV that had resolved without surgery were randomized to mesalazine 1.2, 2.4, or 4.8 g once daily for 24 months. In all studies,

safety was assessed based on adverse event (AE) reporting, physical examinations, assessment of vital signs, and clinical laboratory blood, biochemistry, and urinalysis. The safety profiles of patients across all trials (mesalazine 1.2, 2.4, and 4.8 g/day), patients in UC trials only (mesalazine 2.4 g/day), and patients with DV on high-dose mesalazine (4.8 g/day) were examined independently. Results: A total of 2,859 patients across all trials (1,979 with UC and 880 with DV including 299 on 4.8 g/day mesalazine) received ≥1 dose of multimatrix mesalazine. Overall, 1,542 patients (54%) reported ≥1 treatment emergent AE (TEAE) and 9% discontinued due to TEAEs; maximum severity of TEAEs was mild for 23%, moderate for 24%, and severe for 7%. The most frequently reported TEAEs were abdominal pain (5%), headache (5%), UC (4%), diarrhoea (4%), nasopharyngitis (4%), and urinary tract infection (3%). AEs were determined to be treatment related for 13% of patients; the most frequently reported were diarrhoea (2%), abdominal pain (1%), headache (1%), and UC (1%). For the pooled UC trials only (mesalazine 2.4 g/day), 45% (897/1,979) of patients reported ≥1 TEAE; maximum severity of TEAEs was mild for 23%, moderate for 18%, and severe for 4%. The most common TEAEs were UC (6.