BESS and Stretta are comparable in the amount of time needed to performthe procedures, medication useage and post-procedural recovery time, andboth permit a rapid return to usual lifestyle. These characteristics need tobe considered as further experience defines the cost-effectiveness of thesenovel procedures.

69

Speed of heartburn relief: Lansoprazole vs. omeprazoleJ. Richter, MD1, P. Kahrilas, MD2, S. Sontag, MD3, P. Greski-Rose4, B.Huang5, J. Pencyla4. The Cleveland Clinic Foundation, Cleveland,Ohio1, Northwestern University Medical School, Chicago, Illinois2,Veterans Administration Hospital, Hines, Illinois3, TAP PharmaceuticalProducts Inc4, Lake Forest, Illinois, Abbott Laboratories, Abbott Park,Illinois.5

Purpose:To compare the speed of heartburn (HB) relief after a single doseand through 8 weeks of treatment with lansoprazole 30 mg QD (LAN) andomeprazole 20 mg QD (OME) in patients with endoscopically-diagnosederosive reflux esophagitis (RE).Methods: 3510 patients were randomized to LAN or OME (1:1 ratio) in aU.S., multicenter, double-blind, 8 week treatment study. The primaryefficacy endpoint was HB relief after a single dose, the first week and theentire treatment period by patient diary.Results:

24 Hour Heartburn Baseline Day 1 1 Week 8 Weeks

% of Days w/o HB: LAN 3.9% 33.0%** 58.3%** 76.2%*OME 4.4% 25.4% 52.9% 74.4%

Average Severity/Day†: LAN 2.19 1.05** 0.60** 0.34*OME 2.19 1.24 0.70 0.36

** Statistically significant difference compared with OME (p, 0.0001).* Statistically significant difference compared with OME (p, 0.001).† Symptom score: none5 0; mild 5 1; moderate5 2; severe5 3; very severe5 4.

Significantly greater % of LAN patients reported relief of HB and lesssevere HB than OME patients after a single dose. This significant differ-ence was also seen after one week and through the entire 8 week oftreatment.

Conclusions:LAN is superior to OME for speed of HB relief in patientswith endoscopically-diagnosed erosive RE, especially after a single dose.Moreover, LAN patients reported significantly less severe HB than OMEpatients. Funded by TAP Pharmaceutical Products Inc., Lake Forest, Illi-nois.

70

Comparison of different methods for measurement of esophagealsensation by BarostatY Ringel, M.D., KR Jones, Ph.D, NJ Shaheen, M.D., C Burnett, Ph.D.,B Bradshaw, B.A., DA Drossman, M.D., FACG, WE Whitehead, Ph.D.,FACG. University of NC Center for Functional GI and MotilityDisorders, Chapel Hill, NC.

Background: Because of patient discomfort, it is important to minimizethe number of trials when measuring esophageal sensory thresholds.Aim: To compare different methods for sensory testing, in 11 patients withfunctional esophageal disorders (FED) and 15 healthy volunteers.Methods: (1) TheAscending Methods of Limits(AML) involves succes-sive phasic balloon distentions in stepwise increments of 4 mmHg until thepatient reports moderate pain; and (2) theTracking Techniqueinvolves 20unpredictable phasic balloon distentions at approximately the moderatepain threshold (Whitehead et al., 1998). In both methods subjects report theintensity of their sensations following each distention on a 6-point scale.Sensation thresholds were determined by the mean pressure for all disten-tions in which subjects reported a sensation of moderate intensity or above.Nonparametric Spearman correlations between the sensation thresholds

determined by AML, and the first 10, the second 10, and all 20 trackingtrials were calculated.Results: See table for correlations. Mean thresholds for the AML (23.8mmHg for patients, 27 mmHg for controls) were similar to thresholds forall 20 tracking trials (20.2 mmHg for patients, 31.7 mmHg for controls).

Trackingfirst 10 trials

Tracking11–20 trials

Tracking20 trials

AML Correlation Coefficient 0.916 0.619 0.745Sig. (2-tailed) 0.001 0.006 0.001

AML Controls Correlation Coefficient 0.925 0.690 0.857Sig. (2-tailed) 0.001 0.058 0.007

AML Patients Correlation Coefficient 0.982 0.665 0.841Sig. (2-tailed) 0.001 0.036 0.002

Conclusions:(1) The AML provides as much information on esophagealsensory thresholds as tracking and requires fewer trials. (2) If tracking trialsare used, 10 trials provide as much information as 20.

Supported by a grant from the Multinational Working Team for Diagnosisof Functional GI Disorders.

71

Direct neutralization of esophageal acid by antacid in meal-inducedheartburnMalcolm Robinson, Sheila Rodriguez-Stanley, Arthur A. Ciociola,Jonathan Filinto, Sattar Zubaidi, Philip B. Miner, Jr., Jerry D. Gardner.Oklahoma Foundation for Digestive Research, University of OklahomaHealth Center, Oklahoma City, OK; Warner-Lambert, Morris Plains,NJ; Science for Organizations, Inc., Chatham, NJ.

Background: Antacids are thought to relieve heartburn by neutralizinggastric acid. Previously, we described antacid efficacy in heartburn as dueto direct reduction of intraluminal esophageal acid (Gastroenterology 1999;116:A292).Aim: To use integrated acidity to examine mechanism of action of antacidsin relieving/treating postprandial heartburn.Methods: Subjects (n5 26) with chronic antacid-responsive heartburnunderwent pH monitoring for 4.5 hours post-meal. Subjects self-medicatedwith either placebo or 420 mg calcium carbonate prn symptoms. Integratedacidity was calculated from cumulative, time-weighted mean acid concen-trations in mM (converted from pH each second).Results: Mean dosing time was 1.076 0.07 hours (mean6 SEM) pc.Significant esophageal acid exposure began 45 minutes pc, increased to amaximum between 75–105 minutes, and then decreased to baseline at 145minutes. Gastric acid concentration increased 30 minutes pc, then progres-sively. Antacids significantly decreased esophageal acid concentration be-tween 30–45 minutes after dosing (90–145 minutes pc) with no effect ongastric acid concentration. Esophageal acid concentration was 3.956 2.12mM (mean6 SEM) with placebo and 0.326 0.17 with antacid (p5 0.009)at 90 minutes pc. From 90–145 minutes, gastric acid concentration in-creased from 176 9 to 566 12 mM with placebo and from 116 4 to 44619 mM with antacid (p. 0.36).Conclusions:Antacids decrease esophageal acidity in meal-induced heart-burn by direct neutralization of esophageal acid, not from neutralization ofgastric acid in the stomach as widely believed.(Supported by a grant from Warner-Lambert.)

72

Esophageal acid sensitivity modulates response to acid reducingtherapy in postprandial heartburnSheila Rodriguez-Stanley, Malcolm Robinson, Arthur A. Ciociola,Jonathan Filinto, Sattar Zubaidi, Philip B. Miner, Jr., Jerry D. Gardner.Oklahoma Foundation for Digestive Research, University of OklahomaHealth Sciences Center, Oklahoma City, OK; Warner-Lambert, MorrisPlains, NJ; Science for Organizations, Inc., Chatham, NJ.

2431AJG – September, 2000 Abstracts