from 2449 patients in an open-label, multicenter study of rabeprazole inGERD, the Future of Acid Suppression Therapy (FAST) trial.Results: Prevalence and severity of sGERD were significantly lower inelderly than in younger survey respondents—prevalence: 9.9% vs 14.9%,respectively (P �0.0001); severity: 74% vs 87%, respectively (P �0.05).Nocturnal GERD was less prevalent in elderly than younger people (2.4%vs 4.5%, respectively; P �0.0001). FAST trial results indicated stableprevalence of severe HB (score � 3 on a 0–3 scale) in EE patients �50years (�40%). Severe HB symptoms steadily declined to 24.2% of patientsaged �70 years. This age-related decline was consistent for both day andnight HB. Despite decreased HB severity with age, the FAST trial indicatedan age-associated increase in high-grade EE (modified Hetzel-Dent grades3 and 4). Rabeprazole treatment showed similar efficacy in patients aged�65 years compared with younger patients, despite worse EE in the olderpatients.Conclusions: An inverse relationship was observed between patient ageand GERD symptom severity in both a population survey and clinical trial.Although high-grade EE increased with age, therapeutic response was goodin all age groups. Research supported by Eisai Inc., Teaneck, NJ, andJanssen Pharmaceutica Inc., Titusville, NJ.

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RABEPRAZOLE (RAB) PROVIDES FAST SYMPTOM RELIEFIN GASTROESOPHAGEAL REFLUX DISEASE (GERD)PATIENTS WITH LOW PRETREATMENT HEALTH-RELATEDQUALITY OF LIFE (HRQOL)Malcolm Robinson, M.D., FACG*, Lian Mao, M.S.,Reshmi Siddique, Ph.D., Leonard Jokubaitis, M.D. OklahomaFoundation for Digestive Research, University of Oklahoma HealthCenter, Oklahoma City, OK and Janssen Pharmaceutica Inc., Titusville,NJ.

Purpose: GERD symptoms (eg, heartburn [HB], regurgitation) are knownto significantly impair HRQOL. However, there is little information cor-relating severity of HRQOL impairment with treatment response. Thisstudy evaluated symptom and HRQOL response in the subgroup of RAB-treated erosive esophagitis (EE) patients with low baseline HRQOL in acommunity-based trial.Methods: 2449 patients with endoscopy-confirmed EE were enrolled in anopen-label, multicenter trial. Patients received RAB 20 mg once daily for8 weeks and reported GERD symptoms using a 4-point severity scale(0�none, 3�severe) at baseline, and days 1, 7, and 28 of therapy. Com-plete relief (CR) was defined as a patient with a baseline symptom score �0achieving a score of 0 with treatment. Satisfactory relief (SR) was definedas a change from moderate or severe baseline symptoms (score �1) to ascore of 0 or 1 (none or mild) during therapy. Patients completed anHRQOL Short Form (SF)-36 health survey at baseline. The physicalcomponent summary (PCS) and mental component summary (MCS) scoresof the SF-36 were ranked, and the lowest quartile assessed for CR and SRof day and night HB and regurgitation.Results: Mean baseline SF-36 PCS and MCS were 43.9 and 48.1, respec-tively, with 50 representing the mean in the general population. Patients inthe lowest quartile (n�599) had mean baseline SF-36 PCS of 28.9 (range,10.5–36.8) and MCS of 31.8 (range, 9.3–41.3). In patients with the lowestbaseline HRQOL, most achieved CR and SR of HB with RAB 20 mg(Tables 1 and 2). Similar results were seen with regurgitation over the 4weeks of RAB treatment.

Symptom Relief in Patients With Low Baseline HRQOL PCS

Day HB Night HB

CR SR CR SR

Baseline N 503 387 474 385Day 1 (%) 56.3 70.6 56.9 69.2Day 7 (%) 72.9 81.7 76.6 84.8Day 28 (%) 83.5 92.2 88.8 94.1

Symptom Relief in Patients With Low Baseline HRQOL MCS

Day HB Night HB

CR SR CR SR

Baseline N 505 401 475 388Day 1 (%) 57.5 72.5 61.5 72.3Day 7 (%) 74.5 85.8 77.8 86.3Day 28 (%) 82.5 91.2 85.8 92.7

Conclusions: GERD patients whose symptoms had resulted in the mostsevere impact on HRQOL achieved substantial symptom relief beginningwith the first dose of RAB. Research supported by Eisai Inc., Teaneck, NJ,and Janssen Pharmaceutica Inc., Titusville, NJ.

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IS ESOPHAGECTOMY REALLY A CURE FOR BARRETT’SDYSPLASIA AND CANCER?Herbert C. Wolfsen, M.D., Lois L. Hemminger, A.R.N.P.,Kenneth R. DeVault, M.D.*. Mayo Clinic, Jacksonville, FL.

Purpose: Esophagectomy is considered standard therapy for high-gradedysplastic Barrett’s (BE�HGD) and localized carcinoma (ACA) of thelower esophagus. Traditionally, patients are considered cured after resec-tion of the metaplasia, dysplasia and neoplasia. Although BE has beenreported in patients after esophageal resection it is unclear whether thisrepresents newly formed BE or insufficient resection of all glandularmucosa. The aim of this study was to determine if BE recurs in esopha-gectomy patients after documented, complete BE resection.Methods: After IRB approval, the electronic database was searched forpatients who had undergone esophagectomy for cure at our institution andtheir records were reviewed for endoscopic, histologic and surgical find-ings.Results: Since 1995, 50 patients have undergone esophagectomy forBE�HGD or ACA. Endoscopy was performed in our lab after surgery in38 patients including 7 patients (18%) with recurrent Barrett’s metaplasiaor neoplasia after curative resection (see Table).

Pre-op DiagnosisAge

(years) SexFollow UpDiagnosis

Time toFollow Up Treatment

Barrett’s T3 N0ACA

58 F Barrett’s T2 N1 7 months Surgery

Barrett’s T3 N0ACA

64 F Barrett’s LGD 36 months Observation

BE�HGD 64 M Barrett’s LGD 41 months ObservationBarrett’s T3 N0

ACA69 M Barrett’s T1 N0 18 months Surgery

BE�HGD 72 M Barrett’smetaplasia

84 months Observation

Barrett’s T2 N0ACA

78 M Barrett’smetaplasia

11 months Observation

Barrett’s T2 N0ACA

80 M BE�HGD 88 months Photodynamictherapy

Conclusions: 1) Barrett’s metaplasia, dysplasia or cancer after curativeesophagectomy was common in our patients who underwent at least oneendoscopy after surgery. This appears to represent the development ofmetachronous disease after complete resection of esophageal disease. 2)Several of these patients (3/7) have required intervention–either furthersurgery or PDT. 3) These results support formalized studies to establish theutility of screening endoscopy after “curative” esophagectomy for Barrett’sdysplasia or cancer.

S7AJG – September, Suppl., 2003 Abstracts