April 2008 Volume 134 • Number 4 • Suppl 1
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`www.gastrojournal.org
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`April 30, 2008
`HEALTH SCIENCES
`LIBRARJES
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`Digestive Disease Week®
`and the
`109th Annual Meeting of the
`AGA Institute
`May 17-22, 2008, San Diego, CA
`
`Program of the Annual Meeting of the
`AGA Institute, the American Association for the
`Study of Liver Diseases, the Gastroenterology
`Research Group, the Society for Surgery of the
`Alimentary Tract, and the American Society
`for Gastrointestinal Endoscopy
`
`•
`
`Abstracts of Papers Accepted by the AGA Institute
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`Abstracts of Papers-Accepted by the American
`Association for the Study of Liver Diseases
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`• Abstracts of Papers Accepted by the Society for
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`Surgery of the Alimentary Tract
`
`616.305 GA
`V.134 no.4 suppl.1 Apr. 2008
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`Health Serials
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`DRL EXHIBIT 1011 PAGE 1
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`GASTROENTEROLOGY: GASTAB 134{4) A1-A914(2008)
`ISSN 0016-5085
`© 2008 by the AGA Institute
`
`DRL EXHIBIT 1011 PAGE 2
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`

`

`TABLE OF CONTENTS
`
`AGA Institute Council .......................................... ........................... ....... ........ . x
`
`AGA Institute Abstract Reviewers .................................................. ......... .. xi - xii
`
`Future Meeting Dates ..................................................................... ... .......... xiii
`
`AGA Institute and Digestive Disease Week Program ....................................... xiv
`
`Guide to AGA Institute and Digestive Disease Week Program Pages .... .... ... ..... xv
`
`CME Statements for Digestive Disease Week Sponsoring Societies ................ xvi
`
`AGA Institute and Digestive Disease Week 2008 Week-at-a-Glance ...... P-1 - P-22
`
`AGA Institute and Digestive Disease Week 2008 Program Pages ..... P-23 - P-332
`
`AGA Institute Abstracts ............................................ .......... ....... ..... . A-1 - A-749
`
`American Association for the Study of Liver Disease (AASLD)
`Abstracts ................................................... ............... ... ....... .... A-7 50 - A-843
`
`Society for Surgery of the Alimentary Tract (SSAT) Abstracts ......... A-844 - A-914
`
`Participant Index .................................................................. ... ...... AA-1 - AA-64
`
`Subject Index .............................................................................. AA-65 - AA-80
`
`DRL EXHIBIT 1011 PAGE 3
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`

`

`iplications in Spain. Methods: Setting: 10 general hospitals in Spain attending -
`.000 people. All patients hospitalized due to GI events with diagnostic codes registered
`Mtrumum Basic Data Set that describe GI complication events (AJG 2005) occurring
`partiopating hospital from Jan I , 1996, to Dec 31 , 2005, have been included in
`lllldy All codes identifying either upper, lower or non-defined (e.g. g;istrointestinal
`sour= or GI events have been validated. Results: A total or 30,498 patients had
`n'elllS in 10 ycars. There were clear decreasing trends m the crude rate of upper
`,ts from 77/100,000 people in 1996 (59.6% of all GI events) to 39/100,000 people
`of GI events) in 2005•, and increasing trends in the crude rate of lower GI events
`10 cases/100,000 people (7.9% of GI events) in 1996 to 27/100,000 people (27.9%
`Milts) in 2005•. Occurrence o[ cases with non-specific codes was stable over time.
`reviewing ongmal clinical chans (6726 • 22% of all 30,498 patients) showed
`die source or the event in patients with non-defined GI codes (n•4492) was located
`upper GI tract in 51 % of cases, 28% in the lower GI tract whereas the rest remained
`ltd This suggests that of all hospitalizauon due to GI events, 56% were upper GI
`38% lower GI events and 6 % undefined in the year 2005. Data [rom validation
`of cbans revealed that compared to upper GI events, lower GI events were more
`(dead rate 5.5% vs 8.7%•), had longer duration of hospitalization (7.8±8.4 vs
`IJ9 days•) and higher impact on resource utilization (Group related diagnosis weight•
`U ,-s 1.9,:2.2•). Overall, recorded NSAID/ASA use was lugher in the elderly (> 65
`,, was similar in elderly men with either upper or lower GI events (36.7% vs 31.6%),
`u 111 elderly women (42% vs 31.5%•). Conclusions: Over the last 10 years, there was
`decreasing trend m the rates of hospitalizations due to upper GI complications ,n
`wuh an increasing trend o[ lower GI complications. The clinical impact and severity
`,tahzauons due to lower GI events were greater than those of upper GI events, and
`the elderly, a third or lower GI events were associated with NSAID/ASA use. (•p
`I. chi-square test).
`
`ination of a Cyclooxyge~ ( COX)-2 Selective NSAlD and a Proton
`Inhibitor for Prevention of Gastroduodenal Ulcers in Very High Risk
`ts: A One-Year, Double-Blind, Randomized Trial
`K. L Chan, Bing-yee Suen, Vincent W. Wong, Justin Wu, Joseph jY Sung
`,und & Aims: Among patients with anhritis who had prior ulcer bleeding, we
`ly showed in a randomized trial that none receiving celecoxib plus esomeprazole
`rtCUrrent ulcer bleeding in I year. While endoscopic ulcer remains to be an imponant
`11t for ulcer complications, it is uncertain i[ this treatment strategy could eliminate
`m gastroduodenal ulcers in these very high risk patients. We srudled the ulcer
`1~nct and factors predicting ulcer recurrence in a prospective, double blinded trial or
`
`:,ams wuh pnor ulcer bleeding. Methods: Consecutive patients who presented with NSAID(cid:173)
`-illocwed ulcer bleeding were screened. Patients were enrolled after their ulcers had healed
`911 a test [or Helicclxu:ter pylori was negative. All patients were given celecoxib 200 mg
`-.X daily. They were randomly assigned to receive 20 mg of esomeprazole twice daily
`'1imbmcd-treatmenl group) or a placebo (control group) for 12 months. Patients underwent
`'~ ,f they developed recurrent bleeding. Those without recurrent events underwent
`adoscopy at 1heir last follow-up V1Sil. The endpoint was recurrent endoscopic and/or
`'8du,g ulcers. Analysis was by intention to treaL Results: 273 patients were enrolled, 221
`Isl\) undcrwen1 endoscopy (111 in the combined-treatment group and 110 in the control
`pip). The cumulative incidence of recurrent bleeding ulcers was 0% in the combined(cid:173)
`l!D>Cnl group and 8.9% in the controls (difference, 8.9; 95% Cl, 4.1 to 13.7; p=0.0004).
`1lita1mulauve incidence of recurrent endoscopic ulcers was 6. 7% m the combined-treatment
`pip and 16.8% in the controls (difference, JO.I ; 95% Cl, 1.4 to 18.8; p•0.02). Combining
`ljlalmgand endoscopic ulcers, 6.7% in the combined-treatment group and 25.9% in the
`lltlllD'ols had recurrent ulcers in one year (difference, 19.2; 95% CJ, 9.8 to 28.6; p«).0001).
`5ippmcant dyspepsia (hazard ratio, 11.0; 95% Cl, 3.8 to 31.5), treatmenl assignment (hazard
`..,, 7.6, 95% Cl, 2.9 10 20), concomitant low-dose aspirin (hazard rauo, 2.4; 95% 0,
`LI to 5.1), and ulcer diameter greater than 2 cm (hazard ratio, 2.4; 95% CJ, l.l 10 4.9)
`adtpendently predicted ulcer recurrence. Conclusion: Combined treatment with a COX-2
`trkcuvt NSAID and a proton-pump inhibitor did not totally ehminate ulcer recurrence in
`pioents wuh very high gastrointestinal risk.
`
`A Single Tablet Multilayer Formulation of Enteric-Coated Naproxen Coupled
`111m Noo-Enteric-Coated OMEPRAZOLE ls Associated with a Significantly
`Wuccd Incidence of Gastric Ulcers vs. Enteric-Coated Naproxen: A
`h,spcctive, Randomized, Double-Blind Study
`Jti, L Goldstein, Mark B. Sostek, John G. Fon, Dennis S. Riff, Ying Zhang, John R.
`~ka
`lmoduction: Co-prescribed enteric-<:oated (EC) proton pump inhibitors (PPls) reduce the
`~ of gastric ulcers (GUs) associated with NSAID use. Long-term adherence to such
`ID-dtmpy is suboptimal and new approaches are needed to help ensure full medical benefit,
`Illich may be lost due to non-adherence. The efficacy and safety of a single tablet formulation,
`PN200, which provides sequential delivery of non-EC omeprazole 20 mg + EC naproxen
`,00 mg was compared with EC naproxen 500 mg alone (1wice daily use for both). Methods:
`A6-month, randomized, double-blind, parallel-group, multicenter study included H. pylori(cid:173)
`lllOOCgilllVe pauents who requu-ed chronic NSA1Ds and were at risk of NSAID-associated
`QJs (18-49 y/o with a Hx of GU or duodenal ulcer (DU) within the past 5 yrs, and/or ;.,:50
`Jlo). M>JOr exclusion criteria included use of anlisecretory agents/misoprostol within 14
`days Pauents were randomized to either PN200 bid or EC naproxen 500 mg bid. EGO was
`performed at baseline, l, 3 and 6 months. The primary endpoint was the proponion of
`pumsdevdopinga GU (2:3 mm diameter with depth) during the 6-month study. Secondary
`mdpomts included incidence of DU, tolerability and safety. Results: Baselme demographics
`wtre 5l1Dllar be1ween groups. The table shows the results of the ITI population (randomized
`pums who had no baseline ulcer and reccJVed 2: I dose of study drug) and additional
`n1hs of the sub-population of patients who concomitanlly received low-dose (:5325 mg)
`
`ASA. The proportion of patients discontinuing due to UGI adverse events was 4.4% for
`PN200 and 10.8% for EC naproxen (p.0.012). Conclusion: This multicenter concept
`trial demonstrates that non-EC omeprazole + EC naproxen in a single tablet formulation
`sigrtificantly reduce the incidence of GUs and DUs in the overall population (RR for GU,
`72%), and in those with concomuant ASA therapy (RR for GU, 73%). This approach may
`add to the treatment arrnamentarium for pattents at risk of NSAID-assoc,ated GU, and
`address adherence to GPA co-therapy.
`
`Sw-vival analysis and cumulati ve observed ulcer> [%: (n)l
`
`--- -- ---
`
`DU
`
`PN200 (n=206)
`
`llC naproxcn (n=203)
`
`GU
`
`PN200 (n=206)
`
`EC naproxcn
`(n=203)
`
`1 month
`
`3.411,(7')
`
`10.311> (21)
`
`0.511>(1·)
`
`5.1%(10')
`
`23.111>(40)
`
`0.5%(1·)
`
`5.4'il,(t I)
`
`8.9%(l6)
`
`3
`month,,
`
`6
`n..:>nOiR
`
`6
`months
`
`8.311>" (15' )
`
`29.4 '1 (48)
`
`0.511,• (l'l
`
`I0.811, (18)
`
`Survival analysis and currulMiveobsctvcd GU by ASA use ('ii,; (n)J
`
`PN200 +ASA
`(n-56)
`
`PN200NoASA
`(n= l 50)
`
`EC naproxcn + ASA
`(nz'2)
`
`10.411,(5)
`
`7.6% (l0)
`
`39.()'il,(15)
`
`llC naproxcn No ASA
`
`(n•l51) -
`
`26.511, (33)
`
`'For observed incidence p«).01 at I month and p«).001 at 3 and 6 months (CMH test);
`bfor survival analysis at 6 months p«).001 between groups for GU and DU Oog-rank tcs1)
`
`117
`
`Physicians Fail to Provide Protective Co-Therapy for High GI Risk Patients
`Taking NSAIDs--Eveo with Direct Interactive Communication and Free PPI:
`Results of a Prospective Outcomes Trial
`Loren . Laine, Laurine Connors, Marie R. Griffin. Sean P. Cunis, Chnstopher P. Cannon
`We assessed the success of strategics designed to opttmize adherence to guidelines for co-
`1herapy in NSAID users with increased GI risk in a large, prospective, double-blind outcomes
`trial. METHODS: Anhritis patients 2: 50 yrs were randomly assigned to diclofenac (75 mg
`bid) or etoricoxib (60-90 mg qd). Reminders that protective therapy (PPI or mtSOprostol)
`should be provided to patients with GI risk factors (age > 65 yrs; prior ulcer or hemorrhage;
`use of steroids, anticoagulants or aspirin) were presented at intual investigator meeting.s and
`,n the protocol. Omeprazole was provided at no charge. Midway through the study, an
`intervention was performed: investigators received a form for each patient with a risk factor
`reminding them to provtde co-therapy; if they did not, they were required to return the
`fonn slating the reason. RESULTS: 23,504 were enrolled (14,029 prior to the mtervention).
`15,235 (65%) patients had 2: I risk factor and 7913 (52%) of them received PPI or
`misoprostol (> 99% PPI). Table I shows results relattve to time of m1erven1ion. The main
`reasons for not providing co-therapy were physician judgment (52%) and patient refusal
`(42%). CONCLUSIONS: Approximately 50% of NSAID users with GI risk factors are not
`given protective co-therapy~en if prescribers are remmded repeatedly and the cost of
`therapy is not an issue. Direct communication requiring written response increased adherence
`to guidehnes modestly. Physicians prescribed prophylaxis most often m those with a pnor
`ulcer or hemorrhage and those with multiple risk factors. Achieving high levels or adherence
`to guidelines will be difficult. Our results support the need for patient and physician
`educational programs and pharmacy systems that require prescribers to consider additions
`(e.g., PPL) and/or substitutions (e.g., coxib) in high GI risk patients prescribed NSAIDs .
`Table I. Proponion of patients with nsk factors who received PPI or misoprostol
`
`Risk Fac10r
`
`All patients enrol.led All potic,., enrolled
`post-intctvcntion
`prc-intervc-ntion
`(N=-9,475)
`(N•l4.029)
`
`Any risk factO<
`
`437419347 (47'il)•
`
`3539/5888 (~)
`
`A,e>65
`
`2764/11226 (4411,)•
`
`211113n3 (5811>)
`
`A,e>75
`
`85411878 (45%)•
`
`5451'.128(59%)
`
`Pee -, pos:1 intervention result~ in
`lhc poop of patient, who enrolled
`pre,-in1crvcntion anc.l rcUlaincd in
`study 6 l1lOI post-ln1crvcnlion
`(N•I0.026)
`
`2879/6515 (4411,)--+ 397616515
`(61%)•
`
`1780/4251 (42%)--+ 25 18/4251
`(59%)•
`
`481/1156 (4211,)--+ 670/1156
`(5811,)•
`
`Prior ulcer or
`bemonhlge
`
`695/1040 (67'1,) ..
`
`445/610 (7311,)
`
`446/693 (6411,)-+ 55 1/693 (80'il )•
`
`Sleroid use
`
`48(W')O (49%)•
`
`5991949 (63'11,)
`
`282/631 (4511>)--+ 391/631 (62%)•
`
`Anticol&ulant
`
`"""
`
`'.Zll/58 (48'!1,J••
`
`25/34 (7411>)
`
`18/33 (55%)-+ 25/33 (7611,)
`
`Aspirin USC
`
`2ti08/4926 (5311,)•
`
`1853/2671 (6911>)
`
`t risk factor
`
`245915865 (4211,)•
`
`2179/3982 (5511,)
`
`2 risk factors
`
`1644/3111 (5311,)•
`
`t 169/1673 (?()'ii,)
`
`172613436 (SO'il,) -+ 2239/3436
`(6511,)•
`
`1666,14204 (40%) --+ 2404/4204
`(5711,)•
`
`[~8/2101 (50'.I,)-+ 1402/2 101
`(67':I,)•
`
`3-4 risk factoo
`
`27 1/371 (73'1,) ..
`
`1911233 (82':I,)
`
`155/2 10 (74%)--+ 170/210 (8111,)
`
`Proponions shown are number receiving co-therapy/number with risk factor • p < 0.00001
`pre vs. post-intervention •• p < 0.05 pre vs. post-intervention
`
`A- 19
`
`AGA Abstracts
`
`DRL EXHIBIT 1011 PAGE 4
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