1
the severity of all LI symptoms. In A pts the presence of LI symptoms do not strictly correlate with a positive LBT. On contrary the presence of LI symptoms in NA pts may predict a positive LBT. In particular, diarrhea, adjusted for the anxiety level, seems to be the most significant symptom related to the results of LBT. Su1198 Patient Response to Lubiprostone for the Treatment of Moderate to Severe Irritable Bowel Syndrome With Constipation (IBS-C) Taryn R. Joswick, Fasil Woldegeorgis, Ryuji Ueno INTRODUCTION: Rome Criteria cites abdominal pain as a distinguishing characteristic of patients experiencing IBS-C. Lubiprostone, a selective ClC-2 chloride channel activator, has been shown to accelerate recovery of injured mucosa (Moeser et al, 2007), and was approved for the treatment of IBS-C in women in 2008. Using data collected from two pivotal phase 3, placebo-controlled, 12-week studies, post-hoc analyses were conducted to investigate improvements among the subset of patients reporting more severe IBS-C symptoms at baseline. AIMS & METHODS: Pooled data from two pivotal trials from patients reporting a weekly baseline of moderate or greater abdominal pain and <3 spontaneous bowel movements (SBMs) were assessed for composite response rate. Among patients receiving lubiprostone 8 mcg twice daily (BID) or placebo (BID), responders were required to have a 30% improvement from baseline in mean abdominal pain scores, 1 SBM per week improvement over baseline, and 3 SBMs for 9 of 12 weeks. A similar responder analysis required these criteria to be met for 6 of 12 treatment weeks. Additionally, data from patients with baseline abdominal pain that was rated as severe or very severe were also assessed for weekly improvement in abdominal pain and overall percentage improvement in their abdominal pain scores as compared to baseline. RESULTS: For those patients reporting at least moderate or greater abdominal pain and <3 SBMs per week at baseline, lubiprostone 8 mcg BID produced statistically significantly higher proportions of responders vs. placebo for both 6 of 12 weeks (p=0.0031) and for 9 of 12 weeks (p=0.0109). Additionally, patients with severe or worse abdominal pain at baseline consistently reported more robust improvements in abdominal pain on a weekly basis with lubiprostone treatment versus placebo, which achieved overall statistical significance (p=0.0002). Of those patients with mean ratings of severe or very severe abdominal pain at baseline, 35.1% reported overall improvements of 30% or greater with lubiprostone 8 mcg BID treatment as compared to pre-treatment abdominal pain ratings. Across the assessed range of abdominal pain improvements (10% to 60% change from baseline), the percentage of patients reporting improvement in abdominal pain symptoms at each level was statistically significantly higher than observed in the placebo group (p<0.0001). Most common adverse events were nausea and headache. CONCLUSION: Overall, patients reporting more severe symptoms of IBS-C at baseline showed substantial improvement in these symptoms when treated with lubiprostone 8 mcg BID versus placebo. Furthermore, lubiprostone was well-tolerated over the 12-week treatment period. Lubiprostone 8 mcg BID provides a viable treatment option for patients experiencing IBS-C and, in particular, those with moderate to very severe abdominal pain. Su1199 Lymfocytic and Collagenous Colitis Have a Different Clinical Course; Experience From a Single-Center 10 Year Cohort of 125 Patients Mark van der Lugt, Joop van Baarlen, Maurice G. Russel, Gerard van Olffen, Jeroen J. Kolkman Introduction Microscopic colitis is an infrequent cause of diarrhea, characterized by typical histopathology and normal endoscopic findings. Two types can be distinguished: lymphocytic colitis (LC) and collagenous colitis (CC). After we adapted a colonoscopy biopsy protocol demanding colon biopsies from at least six segments in all patients with diarrhea and normal endoscopic findings > 10 years ago, we increasingly encountered MC. In this study we report on the differences in diagnostic findings, comorbidity, medication use and clinical course in LC and CC in a large, regional hospital. Methods We retrospectively studied patients with microscopic colitis between 1998 and 2009. Patients were identified from the pathology database using the search terms: microscopic colitis, lymphocytis or collagenous colitis. All charts were reviewed and all biopsies re-evaluated. The location of biopsies for making the diagnosis was established during the pathology revision. Comorbidities and medications were recorded, and the clinical course was categorized using three types: A single episode, a chronic remittent course , and a chronic continuous course. To complete follow-up an enquiry was sent to all patients with a last outpatient visit > 12 months ago. Results We identified 181 patients in whom biopsies were available for revision. In 8, an infectious agent was later identified, in 48 histopathology was not conclusive for the diagnosis (mainly because only epithelial lymphocytosis was seen without submucosal inflammation, always LC, never CC). In the remaining 125 patients LC was diagnosed in 77, and CC in 48. The follow-up was median 40 (1-154) months. Biopsies from the right colon were diagnostic in 100% vs. 86% from the left colon (P<0.001). The mean age did not differ between LC and CC (57 and 54 yrs), the F/M ratio was 2,1 in LC and 3.5 in CC. The calculated incidence rate for LC and CC was 3,9 and 2.4 per 100.000 inhabitants. A single MC period was seen more often in LC (49% vs 22%, p=0.02), while chronic continuous S-449 AGA Abstracts and relapsing pattern was seen more often in CC (33% vs 21% and 42% vs 32%, respectively). The cumulative rate of relapse was significantly lower in LC (41% vs 63% p = 0.04). Medication use included NSAID and SSRI in LC in 9% and 12%, and in CC in 17% and 4 %, respectively. In 64 patients duodenal biopsies were taken during work-up. In 51% they showed varying levels of celiac-type abnormalities were found (M-I in 67%, M-II in 12% and M-III in 21%). Conclusion A full colonoscopy with strict histological criteria is mandatory to diagnose LC. Almost halve of LC patients experience only one colitis period, CC is chronic in the vast majority. Left-sided biopsies would have missed 14%; right-sided biopsies were diagnostic in all. Duodenal histpathology suggested celiac-type abnormalities in 51% of those who were studied. Su1200 Prevalence of Diverticular Disease in the General Population, and Link to Diarrhea but Not Constipation or the Irritable Bowel Syndrome Jeong-Yeop Song, Peter T. Schmit, Lars Agreus, Lars Kjellström, Henry Nyhlin, Nicholas J. Talley, Anna N. Andreasson Background: The prevalence of diverticular disease (DD) in the general population is currently unknown. Previous studies on DD were based on autopsies, screening colonoscopies or hospital material (Aliment Pharmacol Ther 2011;33:487-94). The association of DD with chronic gastrointestinal symptoms is controversial but an association between diarrhea- predominant IBS (IBS-D) but not constipation (IBS-C) has been reported (Am J Gastroenterol 2010;105:652-61). Aim: To investigate the prevalence and location of DD in the general population. In addition, we investigated the association between DD and IBS symptoms, hypothesising that individuals with DD would report more IBS-D symptoms. Methods: We analysed the data collected from the Popcol study in which a random representative sample of 745 individuals born in Sweden aged 19-70 years at the selection (mean age 51.7 years) all had a colonoscopy performed and answered several questionnaires regarding GI symptoms, including the Rome II questionnaire. The cecum was reached in 94 % of the colonoscopies. Data on DD were missing in 3 participants, DD localization was missing for 4 participants and IBS symptoms were missing in 43 participants. The associations between DD and age, gender and IBS symptoms were calculated using logistic regression. Results: In total, 130 (17.5 %) had DD of the 742 participants with data on DD. There was no significant difference in prevalence of DD between men and women. The prevalence of DD increased with increasing age (p<.001) and DD was rare in participants younger than 40 years, see figure 1. All subjects with DD had DD in sigmoid. Of those with DD in sigmoid, DD was also found in cecum (3.2 %), ascending colon (4.0 %), flexures and transverse colon (13.6 %), and descending colon (12.7 %). There was no significant difference in presence of IBS between participants with DD versus participants without DD (IBS overall OR: 1.55, 95%CI: .83-2.90; IBS-D OR: 1.67, 95%CI: .61-4.61; IBS-C OR: .93, 95%CI: .24- 3.60, age and gender adjusted). However, adjusted for age and gender, participants with DD were significantly more likely to report mushy stools (OR: 1.88, 95%CI: 1.20-2.96) and high frequency defecation (OR: 2.02, 95%CI: 1.11-3.65) than participants without DD. Use of laxatives did not explain the association between DD and diarrheal symptoms. There were no significant differences in reports of abdominal pain (OR: 1.56, 95%CI: .96-2.54), lumpy stools (OR: 1.43, 95%CI: .88-2.33) or low frequency defecation (OR: 1.02, 95%CI: .47-2.19) between participants with DD versus participants without DD. Conclusion: Sig- moidoscopy may be sufficient to determine the presence of DD, which begins in 30 year olds and increases with age. Presence of DD was not associated with IBS, but DD was associated with diarrheal symptoms of mushy and high frequency stools. Su1202 Clinical Characteristics and Risk Factors of Acute Diverticulitis With Abscess in Japan - Analysis From Japanese Multicenter Large Study Cohort Noriaki Manabe, Ken Haruma, Atsushi Nakajima, Junji Yoshino, Shin'ichi Takahashi, Masami Yamada, Yasuhiko Maruyama, Masanori Gushimiyagi, Takatsugu Yamamoto, Hirokazu Oyamada Background & Aims: In recent years, an increase in the prevalence of diverticulosis of the colon has been reported in Japan as well as in Western countries. About 10-25% of patients with diverticulosis will develop diverticular disease, such as diverticulitis, in their life. Although the majority of patients are treated conservatively, 20-30% of them undergo emergency surgery. Therefore, it is important to know the clinical characteristics and risk factors of the disease. However, little is known about the epidemiology of the disease in Japan. The aim of this study was to clarify the clinical characteristics and risk factors of Japanese patients with diverticulitis with an abscess. Methods: This study was a Japanese multicenter large study cohort. The study subjects were 1,158 patients with acute diverticulitis (689 men, 469 women; mean age 52.6 years) who were diagnosed by ultrasonography and/ or computed tomography between January 2006 and May 2011 in Japan. We investigated their clinical characteristics and risk factors of diverticulitis with an abscess. Results: Diverticu- litis was detected mainly in the middle aged (30 to 50 years old for both men and women). Although diverticulitis frequently developed in the right-sided colon (right side: 67.7%), the ratio of diverticulitis in the left-sided colon was significantly higher in elderly patients AGA Abstracts

Su1200 Prevalence of Diverticular Disease in the General Population, and Link to Diarrhea but Not Constipation or the Irritable Bowel Syndrome

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Page 1: Su1200 Prevalence of Diverticular Disease in the General Population, and Link to Diarrhea but Not Constipation or the Irritable Bowel Syndrome

the severity of all LI symptoms. In A pts the presence of LI symptoms do not strictly correlatewith a positive LBT. On contrary the presence of LI symptoms in NA pts may predict apositive LBT. In particular, diarrhea, adjusted for the anxiety level, seems to be the mostsignificant symptom related to the results of LBT.

Su1198

Patient Response to Lubiprostone for the Treatment of Moderate to SevereIrritable Bowel Syndrome With Constipation (IBS-C)Taryn R. Joswick, Fasil Woldegeorgis, Ryuji Ueno

INTRODUCTION: Rome Criteria cites abdominal pain as a distinguishing characteristic ofpatients experiencing IBS-C. Lubiprostone, a selective ClC-2 chloride channel activator, hasbeen shown to accelerate recovery of injured mucosa (Moeser et al, 2007), and was approvedfor the treatment of IBS-C in women in 2008. Using data collected from two pivotal phase3, placebo-controlled, 12-week studies, post-hoc analyses were conducted to investigateimprovements among the subset of patients reporting more severe IBS-C symptoms atbaseline. AIMS & METHODS: Pooled data from two pivotal trials from patients reporting aweekly baseline ofmoderate or greater abdominal pain and <3 spontaneous bowel movements(SBMs) were assessed for composite response rate. Among patients receiving lubiprostone8 mcg twice daily (BID) or placebo (BID), responders were required to have a ≥30%improvement from baseline in mean abdominal pain scores, ≥1 SBM per week improvementover baseline, and ≥3 SBMs for 9 of 12 weeks. A similar responder analysis required thesecriteria to be met for 6 of 12 treatment weeks. Additionally, data from patients with baselineabdominal pain that was rated as severe or very severe were also assessed for weeklyimprovement in abdominal pain and overall percentage improvement in their abdominalpain scores as compared to baseline. RESULTS: For those patients reporting at least moderateor greater abdominal pain and <3 SBMs per week at baseline, lubiprostone 8 mcg BIDproduced statistically significantly higher proportions of responders vs. placebo for both 6of 12 weeks (p=0.0031) and for 9 of 12 weeks (p=0.0109). Additionally, patients withsevere or worse abdominal pain at baseline consistently reported more robust improvementsin abdominal pain on a weekly basis with lubiprostone treatment versus placebo, whichachieved overall statistical significance (p=0.0002). Of those patients with mean ratings ofsevere or very severe abdominal pain at baseline, 35.1% reported overall improvements of30% or greater with lubiprostone 8 mcg BID treatment as compared to pre-treatmentabdominal pain ratings. Across the assessed range of abdominal pain improvements (≥10%to ≥60% change from baseline), the percentage of patients reporting improvement inabdominal pain symptoms at each level was statistically significantly higher than observedin the placebo group (p<0.0001). Most common adverse events were nausea and headache.CONCLUSION: Overall, patients reporting more severe symptoms of IBS-C at baselineshowed substantial improvement in these symptoms when treated with lubiprostone 8 mcgBID versus placebo. Furthermore, lubiprostonewas well-tolerated over the 12-week treatmentperiod. Lubiprostone 8 mcg BID provides a viable treatment option for patients experiencingIBS-C and, in particular, those with moderate to very severe abdominal pain.

Su1199

Lymfocytic and Collagenous Colitis Have a Different Clinical Course;Experience From a Single-Center 10 Year Cohort of 125 PatientsMark van der Lugt, Joop van Baarlen, Maurice G. Russel, Gerard van Olffen, Jeroen J.Kolkman

Introduction Microscopic colitis is an infrequent cause of diarrhea, characterized by typicalhistopathology and normal endoscopic findings. Two types can be distinguished: lymphocyticcolitis (LC) and collagenous colitis (CC). After we adapted a colonoscopy biopsy protocoldemanding colon biopsies from at least six segments in all patients with diarrhea and normalendoscopic findings > 10 years ago, we increasingly encountered MC. In this study wereport on the differences in diagnostic findings, comorbidity, medication use and clinicalcourse in LC and CC in a large, regional hospital. Methods We retrospectively studiedpatients with microscopic colitis between 1998 and 2009. Patients were identified from thepathology database using the search terms: microscopic colitis, lymphocytis or collagenouscolitis. All charts were reviewed and all biopsies re-evaluated. The location of biopsies formaking the diagnosis was established during the pathology revision. Comorbidities andmedications were recorded, and the clinical course was categorized using three types: Asingle episode, a chronic remittent course , and a chronic continuous course. To completefollow-up an enquiry was sent to all patients with a last outpatient visit > 12 months ago.Results We identified 181 patients in whom biopsies were available for revision. In 8, aninfectious agent was later identified, in 48 histopathology was not conclusive for the diagnosis(mainly because only epithelial lymphocytosis was seen without submucosal inflammation,always LC, never CC). In the remaining 125 patients LC was diagnosed in 77, and CC in48. The follow-up was median 40 (1-154) months. Biopsies from the right colon werediagnostic in 100% vs. 86% from the left colon (P<0.001). The mean age did not differbetween LC and CC (57 and 54 yrs), the F/M ratio was 2,1 in LC and 3.5 in CC. Thecalculated incidence rate for LC and CC was 3,9 and 2.4 per 100.000 inhabitants. A singleMC period was seen more often in LC (49% vs 22%, p=0.02), while chronic continuous

S-449 AGA Abstracts

and relapsing pattern was seen more often in CC (33% vs 21% and 42% vs 32%, respectively).The cumulative rate of relapse was significantly lower in LC (41% vs 63% p = 0.04).Medication use included NSAID and SSRI in LC in 9% and 12%, and in CC in 17% and4 %, respectively. In 64 patients duodenal biopsies were taken during work-up. In 51%they showed varying levels of celiac-type abnormalities were found (M-I in 67%, M-II in12% and M-III in 21%). Conclusion A full colonoscopy with strict histological criteria ismandatory to diagnose LC. Almost halve of LC patients experience only one colitis period,CC is chronic in the vast majority. Left-sided biopsies would have missed 14%; right-sidedbiopsies were diagnostic in all. Duodenal histpathology suggested celiac-type abnormalitiesin 51% of those who were studied.

Su1200

Prevalence of Diverticular Disease in the General Population, and Link toDiarrhea but Not Constipation or the Irritable Bowel SyndromeJeong-Yeop Song, Peter T. Schmit, Lars Agreus, Lars Kjellström, Henry Nyhlin, NicholasJ. Talley, Anna N. Andreasson

Background: The prevalence of diverticular disease (DD) in the general population is currentlyunknown. Previous studies on DD were based on autopsies, screening colonoscopies orhospital material (Aliment Pharmacol Ther 2011;33:487-94). The association of DD withchronic gastrointestinal symptoms is controversial but an association between diarrhea-predominant IBS (IBS-D) but not constipation (IBS-C) has been reported (Am J Gastroenterol2010;105:652-61). Aim: To investigate the prevalence and location of DD in the generalpopulation. In addition, we investigated the association between DD and IBS symptoms,hypothesising that individuals with DD would report more IBS-D symptoms. Methods: Weanalysed the data collected from the Popcol study in which a random representative sampleof 745 individuals born in Sweden aged 19-70 years at the selection (mean age 51.7years) all had a colonoscopy performed and answered several questionnaires regarding GIsymptoms, including the Rome II questionnaire. The cecum was reached in 94 % of thecolonoscopies. Data on DD were missing in 3 participants, DD localization was missing for4 participants and IBS symptoms were missing in 43 participants. The associations betweenDD and age, gender and IBS symptoms were calculated using logistic regression. Results:In total, 130 (17.5 %) had DD of the 742 participants with data on DD. There was nosignificant difference in prevalence of DD between men and women. The prevalence of DDincreased with increasing age (p<.001) and DD was rare in participants younger than 40years, see figure 1. All subjects with DD had DD in sigmoid. Of those with DD in sigmoid,DD was also found in cecum (3.2 %), ascending colon (4.0 %), flexures and transversecolon (13.6 %), and descending colon (12.7 %). There was no significant difference inpresence of IBS between participants with DD versus participants without DD (IBS overallOR: 1.55, 95%CI: .83-2.90; IBS-D OR: 1.67, 95%CI: .61-4.61; IBS-C OR: .93, 95%CI: .24-3.60, age and gender adjusted). However, adjusted for age and gender, participants withDD were significantly more likely to report mushy stools (OR: 1.88, 95%CI: 1.20-2.96) andhigh frequency defecation (OR: 2.02, 95%CI: 1.11-3.65) than participants without DD. Useof laxatives did not explain the association between DD and diarrheal symptoms. Therewere no significant differences in reports of abdominal pain (OR: 1.56, 95%CI: .96-2.54),lumpy stools (OR: 1.43, 95%CI: .88-2.33) or low frequency defecation (OR: 1.02, 95%CI:.47-2.19) between participants with DD versus participants without DD. Conclusion: Sig-moidoscopy may be sufficient to determine the presence of DD, which begins in 30 yearolds and increases with age. Presence of DD was not associated with IBS, but DD wasassociated with diarrheal symptoms of mushy and high frequency stools.

Su1202

Clinical Characteristics and Risk Factors of Acute Diverticulitis With Abscessin Japan - Analysis From Japanese Multicenter Large Study CohortNoriaki Manabe, Ken Haruma, Atsushi Nakajima, Junji Yoshino, Shin'ichi Takahashi,Masami Yamada, Yasuhiko Maruyama, Masanori Gushimiyagi, Takatsugu Yamamoto,Hirokazu Oyamada

Background & Aims: In recent years, an increase in the prevalence of diverticulosis of thecolon has been reported in Japan as well as in Western countries. About 10-25% of patientswith diverticulosis will develop diverticular disease, such as diverticulitis, in their life.Although the majority of patients are treated conservatively, 20-30% of them undergoemergency surgery. Therefore, it is important to know the clinical characteristics and riskfactors of the disease. However, little is known about the epidemiology of the disease inJapan. The aim of this study was to clarify the clinical characteristics and risk factors ofJapanese patients with diverticulitis with an abscess. Methods: This study was a Japanesemulticenter large study cohort. The study subjects were 1,158 patients with acute diverticulitis(689 men, 469 women; mean age 52.6 years) who were diagnosed by ultrasonography and/or computed tomography between January 2006 and May 2011 in Japan. We investigatedtheir clinical characteristics and risk factors of diverticulitis with an abscess. Results: Diverticu-litis was detected mainly in the middle aged (30 to 50 years old for both men and women).Although diverticulitis frequently developed in the right-sided colon (right side: 67.7%),the ratio of diverticulitis in the left-sided colon was significantly higher in elderly patients

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