Rabeprazole (RAB) provides fast symptom relief in gastroesophageal reflux disease (GERD) patients...
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from 2449 patients in an open-label, multicenter study of rabeprazole in GERD, the Future of Acid Suppression Therapy (FAST) trial. Results: Prevalence and severity of sGERD were significantly lower in elderly 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 stable prevalence of severe HB (score 3 on a 0–3 scale) in EE patients 50 years (40%). Severe HB symptoms steadily declined to 24.2% of patients aged 70 years. This age-related decline was consistent for both day and night HB. Despite decreased HB severity with age, the FAST trial indicated an age-associated increase in high-grade EE (modified Hetzel-Dent grades 3 and 4). Rabeprazole treatment showed similar efficacy in patients aged 65 years compared with younger patients, despite worse EE in the older patients. Conclusions: An inverse relationship was observed between patient age and GERD symptom severity in both a population survey and clinical trial. Although high-grade EE increased with age, therapeutic response was good in all age groups. Research supported by Eisai Inc., Teaneck, NJ, and Janssen Pharmaceutica Inc., Titusville, NJ. 19 RABEPRAZOLE (RAB) PROVIDES FAST SYMPTOM RELIEF IN GASTROESOPHAGEAL REFLUX DISEASE (GERD) PATIENTS WITH LOW PRETREATMENT HEALTH-RELATED QUALITY OF LIFE (HRQOL) Malcolm Robinson, M.D., FACG*, Lian Mao, M.S., Reshmi Siddique, Ph.D., Leonard Jokubaitis, M.D. Oklahoma Foundation for Digestive Research, University of Oklahoma Health Center, Oklahoma City, OK and Janssen Pharmaceutica Inc., Titusville, NJ. Purpose: GERD symptoms (eg, heartburn [HB], regurgitation) are known to significantly impair HRQOL. However, there is little information cor- relating severity of HRQOL impairment with treatment response. This study evaluated symptom and HRQOL response in the subgroup of RAB- treated erosive esophagitis (EE) patients with low baseline HRQOL in a community-based trial. Methods: 2449 patients with endoscopy-confirmed EE were enrolled in an open-label, multicenter trial. Patients received RAB 20 mg once daily for 8 weeks and reported GERD symptoms using a 4-point severity scale (0none, 3severe) at baseline, and days 1, 7, and 28 of therapy. Com- plete relief (CR) was defined as a patient with a baseline symptom score 0 achieving a score of 0 with treatment. Satisfactory relief (SR) was defined as a change from moderate or severe baseline symptoms (score 1) to a score of 0 or 1 (none or mild) during therapy. Patients completed an HRQOL Short Form (SF)-36 health survey at baseline. The physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 were ranked, and the lowest quartile assessed for CR and SR of 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 in the lowest quartile (n599) 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 lowest baseline HRQOL, most achieved CR and SR of HB with RAB 20 mg (Tables 1 and 2). Similar results were seen with regurgitation over the 4 weeks of RAB treatment. Symptom Relief in Patients With Low Baseline HRQOL PCS Day HB Night HB CR SR CR SR Baseline N 503 387 474 385 Day 1 (%) 56.3 70.6 56.9 69.2 Day 7 (%) 72.9 81.7 76.6 84.8 Day 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 505 401 475 388 Day 1 (%) 57.5 72.5 61.5 72.3 Day 7 (%) 74.5 85.8 77.8 86.3 Day 28 (%) 82.5 91.2 85.8 92.7 Conclusions: GERD patients whose symptoms had resulted in the most severe impact on HRQOL achieved substantial symptom relief beginning with the first dose of RAB. Research supported by Eisai Inc., Teaneck, NJ, and Janssen Pharmaceutica Inc., Titusville, NJ. 20 IS ESOPHAGECTOMY REALLY A CURE FOR BARRETT’S DYSPLASIA 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-grade dysplastic Barrett’s (BEHGD) and localized carcinoma (ACA) of the lower esophagus. Traditionally, patients are considered cured after resec- tion of the metaplasia, dysplasia and neoplasia. Although BE has been reported in patients after esophageal resection it is unclear whether this represents newly formed BE or insufficient resection of all glandular mucosa. 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 for patients who had undergone esophagectomy for cure at our institution and their records were reviewed for endoscopic, histologic and surgical find- ings. Results: Since 1995, 50 patients have undergone esophagectomy for BEHGD or ACA. Endoscopy was performed in our lab after surgery in 38 patients including 7 patients (18%) with recurrent Barrett’s metaplasia or neoplasia after curative resection (see Table). Pre-op Diagnosis Age (years) Sex Follow Up Diagnosis Time to Follow Up Treatment Barrett’s T3 N0 ACA 58 F Barrett’s T2 N1 7 months Surgery Barrett’s T3 N0 ACA 64 F Barrett’s LGD 36 months Observation BEHGD 64 M Barrett’s LGD 41 months Observation Barrett’s T3 N0 ACA 69 M Barrett’s T1 N0 18 months Surgery BEHGD 72 M Barrett’s metaplasia 84 months Observation Barrett’s T2 N0 ACA 78 M Barrett’s metaplasia 11 months Observation Barrett’s T2 N0 ACA 80 M BEHGD 88 months Photodynamic therapy Conclusions: 1) Barrett’s metaplasia, dysplasia or cancer after curative esophagectomy was common in our patients who underwent at least one endoscopy after surgery. This appears to represent the development of metachronous disease after complete resection of esophageal disease. 2) Several of these patients (3/7) have required intervention– either further surgery or PDT. 3) These results support formalized studies to establish the utility of screening endoscopy after “curative” esophagectomy for Barrett’s dysplasia or cancer. S7 AJG – September, Suppl., 2003 Abstracts
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Transcript of Rabeprazole (RAB) provides fast symptom relief in gastroesophageal reflux disease (GERD) patients...
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
