COTTONE, Mario

Criscouli

Sinagra E

Archivio istituzionale della ricerca - Università di Palermo

t4aoapsmpswasgtoc2rowdpaaasnfncdttoitMarch 2013 CORRESPONDENCE e234. Rungoe C, et al. Gut 2012;Suppl:[Abstract]OP225.5. Storm HH, et al. Dan Med Bull 1997;44:535–539.Conﬂicts of interestThe authors disclose no conﬂicts.http://dx.doi.org/10.1053/j.gastro.2013.01.052Budesonide MMX and Mesalamine toInduce Remission in Patients WithUlcerative ColitisDear Sir:We read with interest about the randomized, controlledtrial (RCT) by Sandborn et al,1 which deserve some com-ments concerning the methodology and the interpreta-tion of the results.First, the authors compared the efficacy of Budes-onide MMX (9 and 6 mg/d) with mesalamine 2.4 g/d orplacebo to induce remission in patients with activemild to moderate ulcerative colitis (UC). When a newdrug must be evaluated versus an old treatment, themain rule is to choose the most appropriate dosage ofthe comparison drug. In 1987, Schroeder et al2 showedhat oral 5-aminosalicylic acid therapy in a dosage of.8 g/d was an effective therapy to induce remission inctive UC. Two successive metaanalyses of the all RCTsf mesalamine confirmed that 3 g/d are needed tochieve the best result.3,4 Therefore, the comparison inthis trial was not appropriate.Second, the clinical and combined remission (clinicaland endoscopic) data observed in this study with me-salamine tablets (34% and 12%, respectively) are at vari-ance with those of published RCTs. Leifeld et al,5 in aooled analysis of 4 RCTs of 3 g/d of mesalamine,howed that tablets were able to obtain a clinical re-ission in 71% and endoscopic remission in 48% ofatients. In the discussion, the authors state that me-alamine 2.4 g/d is not more effective than placebo,hen this statement seems debatable according to thenalysis previously quoted.5Considering that mesalamine is an effective drug inmild-to-moderate, active UC, before introducing budes-onide MMx as a standard treatment for mild to mod-erate UC, it is advisable to design a trial which comparebudesonide MMX with an effective dose of mesalamine.VALERIA CRISCUOLIEMANUELE SINAGRAMARIO COTTONEBiomedical Department of Internal andSpecialist MedicineDivision of MedicineVilla Sofia-V Cervello HospitalPalermo UniversityPalermo, Italy1. Sandborn WJ. Gastroenterology 2012;143:1218–1226.2. Schroeder KW, et al. N Engl J Med 1987;317:1625–1629.3. Ford AC, et al. Am J Gastroenterol 2011;106:601–616.4. Sutherland L. Cochrane Database Syst Rev 2006;2:CD000544.5. Leifeld, et al. Aliment Pharmacol Ther 2011;34:1115–1122.Conﬂicts of interestThe authors disclose no conﬂicts.http://dx.doi.org/10.1053/j.gastro.2012.12.032Reply. We appreciated Criscuoli, Sinagra, and Cottone’scomments regarding our manuscript, “Once-Daily Budes-onide MMX Extended-Release Tablets Induce Remissionin Patients with Mild to Moderate Ulcerative Colitis: Re-sults from the CORE I Study.”1 Their primary concernurrounds the dose of Asacol utilized in the study (2.4/d) and the performance of the drug in the clinical trialhat was designed to examine the efficacy of MMX budes-nide for mild to moderately active ulcerative colitis.There is now abundant evidence that there are notlinically important differences in dose response between.4 and 4.8 g/d for the 2 different dose forms of delayed-elease mesalamine, Asacol2–4 and Lialda,5,6 in patientswith mild to moderately active ulcerative colitis. Based onthese large, randomized, controlled trials and the originaltrial by Sninsky et al,7 which showed that Asacol at dosesf both 1.6 and 2.4 g/d was more effective than placebo,e believe that Asacol 2.4 g/d is an effective dose.Furthermore, the primary goals of our study were toemonstrate the efficacy of budesonide MMX relative tolacebo and to establish a dose response. Those goals werechieved in this study. The nonpowered Asacol referencerm was included at the request of European regulatoryuthorities, and was the approved dose at the time thetudy protocol was designed and approved. The study wasot powered to demonstrate either superiority or nonin-eriority of Asacol relative to MMX budesonide; therefore,o conclusions can be drawn regarding the relative effi-acy of these 2 agents. Last, the trial was not powered toemonstrate the superiority of Asacol relative to placebo;herefore, no conclusions can be from our data regardinghe efficacy of Asacol.We stand by the conclusion of our study, that budes-nide MMX 9 mg/d is effective for induction of remissionn patients with mild to moderately active ulcerative coli-is.WILLIAM J. SANDBORNUniversity of California San DiegoLa Jolla, CaliforniaSIMON TRAVISRadcliff InfirmaryOxford UniversityOxford, UKDAVID BALLARDSantarusDel Mar, California

Budesonide MMX and mesalamine to induce remission in patients with ulcerative colitis

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Budesonide MMX and mesalamine to induce remission in patients with ulcerative colitis

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