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Nocturnal gastric acid secretion is not synonymous with nocturnal esophageal acid exposure except in the presence of hiatal hernia
test. A subgroup of patients (n=11) underwent treated with rabeprazole20 mg bid for 7 days to determinethe response in reducing heartburn symptoms to acid suppression. GERD was defined as the presenceof any of the following: total % time pH<4.0 > 4.3%, DeMeester score >14.3, or Grade >2 esophagitis (Savary-Miller). Results: 41 patients were recruited. 27 patients (mean age 53+7 years, 20 M: 7 F) had evidenceof GERD; 14 patients did not have evidenceof GERD (GERD Neg) (mean age 46+8 years, 9 M: 5 F). Basedon symptom questionnaires,the frequency, severityand duration of heartburnwere similar betweengroups. The GERDgroup had a higher symptom index (SI) on 24 hour pH monitoring in comparison to the GERDNeg group (67 + 9% vs. 36 + 7%; p
is very low. In patients with advancedliver cirrhosis and portal hypertension regular control endoscopies should be performed, as hyperplastic antral polyps can develop. 2237 Absence of Symptoms in Erosive Esophagitis (EE) Patients Treated with Esomeprazole is a Highly Reliable Indicator of Healing David A. Johnson, Eastern Virginia Sch of Medicine, Norfolk, VA; Nimish B. Yakil, Univ of Wisconsin Medical Sch, Milwaukee, Wl; Clara Hwang, Jeffrey G. Levine, AstraZeneca LP, Wayne, PA Purpose: Esomeprazolehas beendemonstratedto be highly effectivefor healingGERDpatients with EE in large, well-controlled, US trials. In these trials, healing was objectively assessed by endoscopy at predetermined endpoints. In clinical practice, it is neither practical nor desirableto endoscopicallyverify healing in all patients. Methods: A total of 4877 EE patients were treated with esomeprazole40 mg (E40, n = 2446) or omeprazole20 mg (020, n = 2431) once daily for up to 8 weeks in US multicenter, randomized, double-blind parallelgroup trials. In this analysis, we examinedthe healing rate among asymptomatic patients at week 4 and determinedthe percentagesof patients who were asymptomatic on each therapy who were also healed.Symptoms were evaluatedby investigatorson the same day endoscopy was performed. A chi-square test was performed to detect the difference in EE healing rate between E4O vs 020 in patients who were asymptomatic at week 4, Results: Heartburn was resolved in 2935 patients and acid regurgitation was resolved in 3572 patients. In those patients who were asymptomatic at week 4, the healing rate was significantly higher in those receiving esomeprazoleversus omeprazole(see table). Conclusions: The practicing clinician can be more confident that EE patients who are asymptomatic after 4 weeks treatment are also healedfollowing therapy with.esomeprazole.Supported by a grant from AstraZenecaLP, Wayne, PA.
2240 Direst Comparison of the Efficacy and Tolerebility of Pantoprazole 20rag (00) with Omeprezole lOmg (OD) as Relapse Prophylaxisfor Patients with Healed Reflux Oesophagitis I Barrison, Hemel Hempstead Hosp, Hemel Hempstead United Kingdom; N Y. Haboubi, Nevill Hall Hosp, AbergavennyUnited Kingdom; A M. Edwards, 8ASF Pharma, Nottingham United Kingdom Introduction: Long-term therapy is warranted in the majority of patients with healed reflux oesophagitissince relapseoccurs in approximately36 to 100% of patients within six months, irrespective of the healing treatment. Aims: To compare the Iong-tarm use (12 month) of pantoprazole20rag once daily with omeprazoielOmg daily as relapseprophylaxis for patients with healed reflux oesophagitis. Methods: Patients with acute reflux oesophaoitis grade II or ill (Savary-Miller Classification) were entered into an eight week run-in period, receiving pantoprazole 4Grog daily. Those with endoscopy-confirmed healing were entered into the double-blind period. During this 12 month period patients were assessedevery three months for symptoms of reflux oesophagitis. Endoscopieswere performed at 26 and 52 weeks into the study and also if patient's symptoms had relapsedfor at least three consecutive days. If the endoscopy confirmed relapse of reflux oesophagitis the patient was withdrawn. Results: 232 patients entered the double-blind period, 197 of which were included in the intend to treat population, 163 in the per protocol population (78 in pantoprazole20mg group and 88 in the omeprazole lOmg group). Of the patients who discontinued the study, 36.2% and 43.6% were withdrawn for endoscopic evidenceof relapse in the pantoprazole20rag treated and omeprazolelOmg treated groups respectively.For the per protocol populationthe KaplanMeier estimation of remission probability was significantly greaterfor the pantoprazole20mg group (0.817) than for the omeprazolelOmg group (0.706) (P
EE Statusin AsymptomaticGERDPatientsalter 4 Weeksof Treatment Symptoms
E40 Healed
E40 Not Healed
020 Healed
020 Not Healed
Heart.bum Acid Regurg.
1294(83.4) 1474(81.0")
257 (16.6) 346 (19.0)
1044(75.4) 1255 (71.6)
340 (24.6) 497 (28.4)
Dataare presentedas numberand percentageof patients "p < 0.001vs. 020 2238 Nocturnal Gastric Acid Secretion is Not Synonymouswith Nocturnal Esophageal Acid Exposure Except in the Presence of Hiatal Hernia Amar Bansal, Colin W. Howden, Michael P. dunes, Northwestern Univ Medical Sch, Chicago, IL Introduction: While PPIs are clearly the most effective agents in controlling gastric acid secretion, suboptimal control of gastric acid secretion, particularly at night, is increasingly recognized.The present study was a retrospectiveanalysis of pts with a clinical diagnosis of GERD undergoing esophagealpH monitoring (priM). The specific aim was to determine the prevalence of esophagealacid exposure, particularly at night, in pts on PPIs. Methods: 250 consecutive pH studies done for GERD-relatedsymptomatolooy were reviewed. Pts having undergone fundoplication or myetomy were excluded. Primary variables of interest were %time pH<4 for the entire study as well as for the nocturnal period (0001-0600hrs). Pathologic esophagealacid exposure (PAE) was defined as pH<4 >5% of the study period. Additional variablesof interest included symptom index and presenceof hiatal hernia (HH)asdetermined from endoscopic reports. Results: PAE was noted in 35% of pts studied on no muds. 107/ 250 pts were studied on PPIs and 100 pts taking PPI qD or bid were evaluatedfurther. Study indications in these pts included GERD(61),chest pain(17), cough(8), asthma(2) and other(9). PAE was noted in 18/60 (30%)of qD PPI users and 14/40(35%) of bid PPI users. 16132 PPI pts with PAE had some nocturnal acid exposure but only 9/32 (28%) had nocturnal PAE. 2/ 16(13%)' pts with any nocturnal acid exposure had associated symptoms with symptom indices of 2/2 (lOO%)and 2/9 (22%). Endoscopy reports were available for 20/32 pts with any nocturnal acid exposure and revealedHH in 4/5 pts with noctumal acid exposure and 7/ 15 without nocturnal acid exposure (OR =4.57). Conc/usions:Despite PPI, approximately 1/ 3 of GERDpts still have PAE.Of these, approximately1/2 havesome nocturnal acid exposure, but only 1/4 have nocturnal PAE. The liklehood of nocturnal acid exposure is increased in pts with HH. Nocturnal PAE occurs in the minority of GERD pts with suboptimal response to PPI therapy and few of those have associatedsymptoms. The risk for nocturnal esophageal acid exposure is greatest in pts with HH.
2241 EsophagophanjngealAcid Regurgitation Before And During Treatment With Omeprazale in Patients With Posterior Laryngitis Angel Alvarez-Sanchez,Enrique Roy, Cristina Urbasos, Joaquin Poch-Broto, Manuel DiazRuble, Hosp Clinico San Carlos, Madrid Spain PharyngealpH monitoring has been used to identify gastroesophagealreflux (GER)in patients with posterior laringitis (PL). Empiric antireflux long term therapy with high dose omeprazole has been shown to be effective. AIM: to determine whether high dose omeprazoletherapy had different effect on GER and esophagopharyngealacid regurgitation episodes.METHODS: 16 patientswith PL (diagnosedby videolaryngostmboscopicevaluation)were studied. Patients underwent 24-h ambulatory dual-probe pH monitoring (pharyngeal electrode placed 1 cm above the upper esophagealsphincter and esophagealelectrodeplaced 5 cm abovethe upper border of lower esophagealsphincter) before and during treatment with omeprazole(20 mg twice daily). Pharyngealacid episode was defined as a decreasein pH below 4 at pharyngeal electrode. Gastroesophagealreflux episode (GER) was defined as a decrease in pH below 4 at esophagealelectrode. Esophagopharyngealacid regurgitation was defined as a pharyngeal pH decreasethat ocurred in less than 30 seconds during esophagealacidification. Variables studied were GER episodes, esophagopharyngealacid regurgitation episodes and % GER episodes reaching pharynx. Comparisonswere made by .WilcoxonTest for paired data. Data are expressedas median (interquartile range). RESULTS:table summafises the results: CONCLUSION: treatment with orneprazole decreased the number of GER episodes more than esophagopharingealacid regurgitation episodes in patients with posterior laryngitis. These findings may explain why high dose and long term therapy with omeprazole is required in these patients.
2239 Characterization 0! Patients With Heartburn Who Have A Normal EndoscopyAnd 24 Hour pH Monitoring Tony Lembo, Robin Dann, Beth Israel DeaconessMedical Ctr, Boston, MA; Ronnie Fass, Southern Arizona VA Health Care System, Tucson, AZ Heartburn is most often causedby gastroesophagealreflux disease(GERD),howevera subset of patientswith heartburn has no evidenceof GERD(24 hour pH monitoring and endoscopy). The cause of heartbum in these patients is not known but may be secondaryto unrecognized GERD,hypersensitiveesophagusor other functional bowel disorders. We sought to determine the clinical characteristicsand responseto treatment (proton pump inhibitor) in patients with chronic heartburn who do not have evidenceof GERD in comparison to patients with documented GERD. Methods: Consecutive patients referred to the GI clinics with the primary complaint of heartburn were recruited at 2 major medical centers. All patients completed validated GERD, quality of life and psychological questionnaires. All patients underwent 24hour pH study (off antisecretory medications), upper endoscopy, and a modified Bernstein
Before Treatment Eenphago-phadngesl 2 (1-6.7) acid regurgitation episodes GERepisodes 44.5 (13-71,5) %GERepisodes 5.9 (2.5-26.5) renchin9 phadnx
A-439
Dudn9 Treatment
p
1 (0.25-4)
ns
10.5 (2.2-30,7) 13.8 (1-25.7)
p<0.05 ns
is very low. In patients with advancedliver cirrhosis and portal hypertension regular control endoscopies should be performed, as hyperplastic antral polyps can develop. 2237 Absence of Symptoms in Erosive Esophagitis (EE) Patients Treated with Esomeprazole is a Highly Reliable Indicator of Healing David A. Johnson, Eastern Virginia Sch of Medicine, Norfolk, VA; Nimish B. Yakil, Univ of Wisconsin Medical Sch, Milwaukee, Wl; Clara Hwang, Jeffrey G. Levine, AstraZeneca LP, Wayne, PA Purpose: Esomeprazolehas beendemonstratedto be highly effectivefor healingGERDpatients with EE in large, well-controlled, US trials. In these trials, healing was objectively assessed by endoscopy at predetermined endpoints. In clinical practice, it is neither practical nor desirableto endoscopicallyverify healing in all patients. Methods: A total of 4877 EE patients were treated with esomeprazole40 mg (E40, n = 2446) or omeprazole20 mg (020, n = 2431) once daily for up to 8 weeks in US multicenter, randomized, double-blind parallelgroup trials. In this analysis, we examinedthe healing rate among asymptomatic patients at week 4 and determinedthe percentagesof patients who were asymptomatic on each therapy who were also healed.Symptoms were evaluatedby investigatorson the same day endoscopy was performed. A chi-square test was performed to detect the difference in EE healing rate between E4O vs 020 in patients who were asymptomatic at week 4, Results: Heartburn was resolved in 2935 patients and acid regurgitation was resolved in 3572 patients. In those patients who were asymptomatic at week 4, the healing rate was significantly higher in those receiving esomeprazoleversus omeprazole(see table). Conclusions: The practicing clinician can be more confident that EE patients who are asymptomatic after 4 weeks treatment are also healedfollowing therapy with.esomeprazole.Supported by a grant from AstraZenecaLP, Wayne, PA.
2240 Direst Comparison of the Efficacy and Tolerebility of Pantoprazole 20rag (00) with Omeprezole lOmg (OD) as Relapse Prophylaxisfor Patients with Healed Reflux Oesophagitis I Barrison, Hemel Hempstead Hosp, Hemel Hempstead United Kingdom; N Y. Haboubi, Nevill Hall Hosp, AbergavennyUnited Kingdom; A M. Edwards, 8ASF Pharma, Nottingham United Kingdom Introduction: Long-term therapy is warranted in the majority of patients with healed reflux oesophagitissince relapseoccurs in approximately36 to 100% of patients within six months, irrespective of the healing treatment. Aims: To compare the Iong-tarm use (12 month) of pantoprazole20rag once daily with omeprazoielOmg daily as relapseprophylaxis for patients with healed reflux oesophagitis. Methods: Patients with acute reflux oesophaoitis grade II or ill (Savary-Miller Classification) were entered into an eight week run-in period, receiving pantoprazole 4Grog daily. Those with endoscopy-confirmed healing were entered into the double-blind period. During this 12 month period patients were assessedevery three months for symptoms of reflux oesophagitis. Endoscopieswere performed at 26 and 52 weeks into the study and also if patient's symptoms had relapsedfor at least three consecutive days. If the endoscopy confirmed relapse of reflux oesophagitis the patient was withdrawn. Results: 232 patients entered the double-blind period, 197 of which were included in the intend to treat population, 163 in the per protocol population (78 in pantoprazole20mg group and 88 in the omeprazole lOmg group). Of the patients who discontinued the study, 36.2% and 43.6% were withdrawn for endoscopic evidenceof relapse in the pantoprazole20rag treated and omeprazolelOmg treated groups respectively.For the per protocol populationthe KaplanMeier estimation of remission probability was significantly greaterfor the pantoprazole20mg group (0.817) than for the omeprazolelOmg group (0.706) (P
EE Statusin AsymptomaticGERDPatientsalter 4 Weeksof Treatment Symptoms
E40 Healed
E40 Not Healed
020 Healed
020 Not Healed
Heart.bum Acid Regurg.
1294(83.4) 1474(81.0")
257 (16.6) 346 (19.0)
1044(75.4) 1255 (71.6)
340 (24.6) 497 (28.4)
Dataare presentedas numberand percentageof patients "p < 0.001vs. 020 2238 Nocturnal Gastric Acid Secretion is Not Synonymouswith Nocturnal Esophageal Acid Exposure Except in the Presence of Hiatal Hernia Amar Bansal, Colin W. Howden, Michael P. dunes, Northwestern Univ Medical Sch, Chicago, IL Introduction: While PPIs are clearly the most effective agents in controlling gastric acid secretion, suboptimal control of gastric acid secretion, particularly at night, is increasingly recognized.The present study was a retrospectiveanalysis of pts with a clinical diagnosis of GERD undergoing esophagealpH monitoring (priM). The specific aim was to determine the prevalence of esophagealacid exposure, particularly at night, in pts on PPIs. Methods: 250 consecutive pH studies done for GERD-relatedsymptomatolooy were reviewed. Pts having undergone fundoplication or myetomy were excluded. Primary variables of interest were %time pH<4 for the entire study as well as for the nocturnal period (0001-0600hrs). Pathologic esophagealacid exposure (PAE) was defined as pH<4 >5% of the study period. Additional variablesof interest included symptom index and presenceof hiatal hernia (HH)asdetermined from endoscopic reports. Results: PAE was noted in 35% of pts studied on no muds. 107/ 250 pts were studied on PPIs and 100 pts taking PPI qD or bid were evaluatedfurther. Study indications in these pts included GERD(61),chest pain(17), cough(8), asthma(2) and other(9). PAE was noted in 18/60 (30%)of qD PPI users and 14/40(35%) of bid PPI users. 16132 PPI pts with PAE had some nocturnal acid exposure but only 9/32 (28%) had nocturnal PAE. 2/ 16(13%)' pts with any nocturnal acid exposure had associated symptoms with symptom indices of 2/2 (lOO%)and 2/9 (22%). Endoscopy reports were available for 20/32 pts with any nocturnal acid exposure and revealedHH in 4/5 pts with noctumal acid exposure and 7/ 15 without nocturnal acid exposure (OR =4.57). Conc/usions:Despite PPI, approximately 1/ 3 of GERDpts still have PAE.Of these, approximately1/2 havesome nocturnal acid exposure, but only 1/4 have nocturnal PAE. The liklehood of nocturnal acid exposure is increased in pts with HH. Nocturnal PAE occurs in the minority of GERD pts with suboptimal response to PPI therapy and few of those have associatedsymptoms. The risk for nocturnal esophageal acid exposure is greatest in pts with HH.
2241 EsophagophanjngealAcid Regurgitation Before And During Treatment With Omeprazale in Patients With Posterior Laryngitis Angel Alvarez-Sanchez,Enrique Roy, Cristina Urbasos, Joaquin Poch-Broto, Manuel DiazRuble, Hosp Clinico San Carlos, Madrid Spain PharyngealpH monitoring has been used to identify gastroesophagealreflux (GER)in patients with posterior laringitis (PL). Empiric antireflux long term therapy with high dose omeprazole has been shown to be effective. AIM: to determine whether high dose omeprazoletherapy had different effect on GER and esophagopharyngealacid regurgitation episodes.METHODS: 16 patientswith PL (diagnosedby videolaryngostmboscopicevaluation)were studied. Patients underwent 24-h ambulatory dual-probe pH monitoring (pharyngeal electrode placed 1 cm above the upper esophagealsphincter and esophagealelectrodeplaced 5 cm abovethe upper border of lower esophagealsphincter) before and during treatment with omeprazole(20 mg twice daily). Pharyngealacid episode was defined as a decreasein pH below 4 at pharyngeal electrode. Gastroesophagealreflux episode (GER) was defined as a decrease in pH below 4 at esophagealelectrode. Esophagopharyngealacid regurgitation was defined as a pharyngeal pH decreasethat ocurred in less than 30 seconds during esophagealacidification. Variables studied were GER episodes, esophagopharyngealacid regurgitation episodes and % GER episodes reaching pharynx. Comparisonswere made by .WilcoxonTest for paired data. Data are expressedas median (interquartile range). RESULTS:table summafises the results: CONCLUSION: treatment with orneprazole decreased the number of GER episodes more than esophagopharingealacid regurgitation episodes in patients with posterior laryngitis. These findings may explain why high dose and long term therapy with omeprazole is required in these patients.
2239 Characterization 0! Patients With Heartburn Who Have A Normal EndoscopyAnd 24 Hour pH Monitoring Tony Lembo, Robin Dann, Beth Israel DeaconessMedical Ctr, Boston, MA; Ronnie Fass, Southern Arizona VA Health Care System, Tucson, AZ Heartburn is most often causedby gastroesophagealreflux disease(GERD),howevera subset of patientswith heartburn has no evidenceof GERD(24 hour pH monitoring and endoscopy). The cause of heartbum in these patients is not known but may be secondaryto unrecognized GERD,hypersensitiveesophagusor other functional bowel disorders. We sought to determine the clinical characteristicsand responseto treatment (proton pump inhibitor) in patients with chronic heartburn who do not have evidenceof GERD in comparison to patients with documented GERD. Methods: Consecutive patients referred to the GI clinics with the primary complaint of heartburn were recruited at 2 major medical centers. All patients completed validated GERD, quality of life and psychological questionnaires. All patients underwent 24hour pH study (off antisecretory medications), upper endoscopy, and a modified Bernstein
Before Treatment Eenphago-phadngesl 2 (1-6.7) acid regurgitation episodes GERepisodes 44.5 (13-71,5) %GERepisodes 5.9 (2.5-26.5) renchin9 phadnx
A-439
Dudn9 Treatment
p
1 (0.25-4)
ns
10.5 (2.2-30,7) 13.8 (1-25.7)
p<0.05 ns