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Once-daily esomeprazole and twice-daily lansoprazole in controlling epigastric pain and acid regurgitation in patients with resistant GERD
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Abstracts
reversal. Thus, an abnormal baseline 24 hr pH is significantly predictive of the need for increased PPI dose during endoscopic ablation of BE. 107 ONCE-DAILY ESOMEPRAZOLE AND TWICE-DAILY LANSOPRAZOLE IN CONTROLLING EPIGASTRIC PAIN AND ACID REGURGITATION IN PATIENTS WITH RESISTANT GERD Ronnie Fass, M.D., FACG*, Barry M. Traxler, B.S., Samisha Thomas, B.A., Mark B. Sostek, M.D. University of Arizona Health Sciences Center, Tucson, AZ and AstraZeneca LP, Wilmington, DE. Purpose: In clinical practice there is a tendency to use increased doses of a proton pump inhibitor if the desired clinical response is not achieved with the standard dose. The purpose of ths study was to compare the symptom relieving effects of esomeprazole (Eso) 40mg once daily (qd) to those of lansoprazole (Lanso) 30mg twice daily (bid) on epigastric pain and acid regurgitation in patients with symptomatic gastroesophageal reflux disease (GERD) resistant to treatment with Lanso 30mg qd. Methods: This was a multicenter, prospective, randomized, double-blind, comparative study conducted at 52 sites in the US. Patients with GERD taking Lanso 30mg qd with a history of heartburn symptoms for a minimum of 3 months, and occurring ⱖ2 days per week on average, were eligible for enrollment. Eligibility was confirmed by completing a symptom diary during a 2-week run-in period while taking Lanso 30mg qd. Eligible patients were randomized to Eso 40mg qd or Lanso 30mg bid for 8 weeks. Episodes of epigastric pain and acid regurgitation were recorded daily in a patient diary throughout the 8 weeks of treatment. The percentages of symptom-free days post washout from Lanso 30mg qd to the end of treatment were analyzed from diary data using an analysis of covariance model (ANCOVA) from which the least-squared mean estimates were obtained for the 2 treatments. The study was powered to statistically rule out a prespecified clinically significant difference between the 2 treatments. Results: The intent-to-treat (ITT) population consisted of 138 (41% male, mean age 49 years) and 144 (46% male, mean age 48 years) patients in the Eso and Lanso groups, respectively. The percentage of symptom-free days during the study period was similar between treatment groups for both epigastric pain (Eso 65% vs Lanso 67%, P⫽NS) and acid regurgitation (Eso 60% vs Lanso 65%, P⫽NS). Changes from baseline in weekly average symptom severity scores during treatment were virtually identical between the two treatments, and similar proportions of patients in each group showed symptom improvement from baseline during the final week on treatment. Both treatments were well tolerated. Conclusions: Eso 40mg qd provides clinically similar effects to Lanso 30mg in controlling epigastric pain and acid regurgitation in patients with GERD resistant to treatment with Lanso 30mg qd. Eso therapy may provide an opportunity to avoid Lanso bid therapy in this difficult patient population. 108 COMPARISON OF TRANSNASALY PLACED WIRELESS PH CAPSULE (BRAVO威) VERSUS TRADITIONAL 24-HOUR ESOPHAGEAL PH MONITORING-A RANDOMIZED TRIAL Roy Dekel, M.D., Isaac B. Malagon, B.S., Colleen Green, M.S., Ronnie Fass, M.D.*. Southern Arizona VA Health Care System, Tucson, AZ. Purpose: The wireless pH capsule (BRAVO威) can be placed either during endoscopy or transnasaly. However, for open-access motility laboratories, the latter technique is more relevant. Our aim was to compare the feasibility and tolerability of transnasal placement of the wireless pH capsule versus the traditional pH probe. Methods: Consecutive patients referred for a pH test were enrolled. Patients were randomized to the traditional pH probe, or to transnasaly placed wireless pH capsule. During the test the patients recorded their activities,
AJG – Vol. 98, No. 9, Suppl., 2003
food consumption, symptoms, and satisfaction with the test. Additionally, patients completed the GERD-Health related quality of life questionnaire. Results: The analysis included 32 patients (of those 2 failed the transnasal capsule placement and were crossed-over to the pH probe). Seventeen patients (mean age 49.3⫾3.3, 9M) were randomized to the traditional pH, and 15 (mean age 52.8⫾2.1, 6M) to the wireless capsule. Percent total time pH⬍4 was not different between the groups on and off PPI (p⫽NS). Symptoms report was similar in both groups, on and off PPI therapy. While there was no difference in the number of meals between groups, patients with the wireless capsule spent significantly more time eating breakfast then those with the traditional probe (p⬍0.05). Alcohol, coffee consumption, and smoking during the test were not different between the 2 groups. Patients in the wireless capsule group had significantly less nose pain, running nose, throat pain, and throat discomfort as compared with the traditional pH probe group (p⫽0.03, p⫽0.001, p⫽0.02, p⫽0.001, respectively). However, during insertion of the capsule, 86% of patients experienced mild and transient nosebleed. Patients in the wireless capsule group perceived the study as less interfering with their overall daily activities and sleep (p⫽0.006 and p⫽0.03, respectively). Patients in the wireless capsule group were significantly less bothered by the test and rated their overall satisfaction as better as compared to those with the traditional probe (p⬍0.0001, p⫽0.005 respectively). Significantly more patients in the wireless capsule group stated that they would be willing to undergo the test again if necessary, as compared to those in the traditional pH probe group (p⫽0.02). Conclusions: Transnasaly placed wireless pH capsule is significantly better tolerated then the traditional pH probe. Consequently, it is an attractive modality for open-access motility laboratories.
STOMACH 109 GASTRIC ACCOMMODATION AND GASTRIC EMPTYING IN PATIENTS WITH FUNCTIONAL DYSPEPSIA Mohamed N.A. Al-Aghbar, Ph.D.*. Basel Medical Center, Abu Dhabi, Abu Dhabi, United Arab Emirates. Purpose: To investigate gastric accommodation and gastric emptying in patients with functional dyspepsia and normal controls. Methods: Gastric volume was measured by ultrasound taking three dimensions: Londitudinal, transverse and oblique in 20 patients with functional dyspepsia and in 11 normal controls.The following parameters were measured: Fasting water load. Fasting gastric volume. Post drinking water gastric volume. Post drinking water gastric volume change. The ratio of post drinking water gastric volume to fasting gastric volume. These parameters were used for the determination of gastric accommodation. Gastric emptying rate was determined by the formula: post drinking water gastric volume ⫺ post drinking water gastric volume after 25 minutes ⫻ 100. Results: 1. Fasting water load, fasting gastric volume and post drinking water gastric volume were not significantly different in both groups. 2. Post drinking water gastric volume change and the ratio of post drinking water gastric volume to fasting gastric volume were significantly reduced in patients with functional dyspepsia compared to normal controls: (802⫾322 and 585⫾242 0.05 ⬎P⬎0.02 ) and (32.9⫾16.8 and 19.7⫾7.2 0.01⬎ P⬎0.001) respectively. This indicates that gastric accommodation was significantly decreased in patients with functional dyspepsia. Reduced gastric accommodation was observed in 60 % of patients with functional dyspepsia and was significantly reduced in male patients. 3. Post drinking water gastric volume ⫺ post drinking water gastric volume after 25 minutes ⫻ 100 was significantly reduced in patients with functional dyspepsia compared to normal controls (68⫾13.8% and 44.9⫾16.5%) 0.01
Abstracts
reversal. Thus, an abnormal baseline 24 hr pH is significantly predictive of the need for increased PPI dose during endoscopic ablation of BE. 107 ONCE-DAILY ESOMEPRAZOLE AND TWICE-DAILY LANSOPRAZOLE IN CONTROLLING EPIGASTRIC PAIN AND ACID REGURGITATION IN PATIENTS WITH RESISTANT GERD Ronnie Fass, M.D., FACG*, Barry M. Traxler, B.S., Samisha Thomas, B.A., Mark B. Sostek, M.D. University of Arizona Health Sciences Center, Tucson, AZ and AstraZeneca LP, Wilmington, DE. Purpose: In clinical practice there is a tendency to use increased doses of a proton pump inhibitor if the desired clinical response is not achieved with the standard dose. The purpose of ths study was to compare the symptom relieving effects of esomeprazole (Eso) 40mg once daily (qd) to those of lansoprazole (Lanso) 30mg twice daily (bid) on epigastric pain and acid regurgitation in patients with symptomatic gastroesophageal reflux disease (GERD) resistant to treatment with Lanso 30mg qd. Methods: This was a multicenter, prospective, randomized, double-blind, comparative study conducted at 52 sites in the US. Patients with GERD taking Lanso 30mg qd with a history of heartburn symptoms for a minimum of 3 months, and occurring ⱖ2 days per week on average, were eligible for enrollment. Eligibility was confirmed by completing a symptom diary during a 2-week run-in period while taking Lanso 30mg qd. Eligible patients were randomized to Eso 40mg qd or Lanso 30mg bid for 8 weeks. Episodes of epigastric pain and acid regurgitation were recorded daily in a patient diary throughout the 8 weeks of treatment. The percentages of symptom-free days post washout from Lanso 30mg qd to the end of treatment were analyzed from diary data using an analysis of covariance model (ANCOVA) from which the least-squared mean estimates were obtained for the 2 treatments. The study was powered to statistically rule out a prespecified clinically significant difference between the 2 treatments. Results: The intent-to-treat (ITT) population consisted of 138 (41% male, mean age 49 years) and 144 (46% male, mean age 48 years) patients in the Eso and Lanso groups, respectively. The percentage of symptom-free days during the study period was similar between treatment groups for both epigastric pain (Eso 65% vs Lanso 67%, P⫽NS) and acid regurgitation (Eso 60% vs Lanso 65%, P⫽NS). Changes from baseline in weekly average symptom severity scores during treatment were virtually identical between the two treatments, and similar proportions of patients in each group showed symptom improvement from baseline during the final week on treatment. Both treatments were well tolerated. Conclusions: Eso 40mg qd provides clinically similar effects to Lanso 30mg in controlling epigastric pain and acid regurgitation in patients with GERD resistant to treatment with Lanso 30mg qd. Eso therapy may provide an opportunity to avoid Lanso bid therapy in this difficult patient population. 108 COMPARISON OF TRANSNASALY PLACED WIRELESS PH CAPSULE (BRAVO威) VERSUS TRADITIONAL 24-HOUR ESOPHAGEAL PH MONITORING-A RANDOMIZED TRIAL Roy Dekel, M.D., Isaac B. Malagon, B.S., Colleen Green, M.S., Ronnie Fass, M.D.*. Southern Arizona VA Health Care System, Tucson, AZ. Purpose: The wireless pH capsule (BRAVO威) can be placed either during endoscopy or transnasaly. However, for open-access motility laboratories, the latter technique is more relevant. Our aim was to compare the feasibility and tolerability of transnasal placement of the wireless pH capsule versus the traditional pH probe. Methods: Consecutive patients referred for a pH test were enrolled. Patients were randomized to the traditional pH probe, or to transnasaly placed wireless pH capsule. During the test the patients recorded their activities,
AJG – Vol. 98, No. 9, Suppl., 2003
food consumption, symptoms, and satisfaction with the test. Additionally, patients completed the GERD-Health related quality of life questionnaire. Results: The analysis included 32 patients (of those 2 failed the transnasal capsule placement and were crossed-over to the pH probe). Seventeen patients (mean age 49.3⫾3.3, 9M) were randomized to the traditional pH, and 15 (mean age 52.8⫾2.1, 6M) to the wireless capsule. Percent total time pH⬍4 was not different between the groups on and off PPI (p⫽NS). Symptoms report was similar in both groups, on and off PPI therapy. While there was no difference in the number of meals between groups, patients with the wireless capsule spent significantly more time eating breakfast then those with the traditional probe (p⬍0.05). Alcohol, coffee consumption, and smoking during the test were not different between the 2 groups. Patients in the wireless capsule group had significantly less nose pain, running nose, throat pain, and throat discomfort as compared with the traditional pH probe group (p⫽0.03, p⫽0.001, p⫽0.02, p⫽0.001, respectively). However, during insertion of the capsule, 86% of patients experienced mild and transient nosebleed. Patients in the wireless capsule group perceived the study as less interfering with their overall daily activities and sleep (p⫽0.006 and p⫽0.03, respectively). Patients in the wireless capsule group were significantly less bothered by the test and rated their overall satisfaction as better as compared to those with the traditional probe (p⬍0.0001, p⫽0.005 respectively). Significantly more patients in the wireless capsule group stated that they would be willing to undergo the test again if necessary, as compared to those in the traditional pH probe group (p⫽0.02). Conclusions: Transnasaly placed wireless pH capsule is significantly better tolerated then the traditional pH probe. Consequently, it is an attractive modality for open-access motility laboratories.
STOMACH 109 GASTRIC ACCOMMODATION AND GASTRIC EMPTYING IN PATIENTS WITH FUNCTIONAL DYSPEPSIA Mohamed N.A. Al-Aghbar, Ph.D.*. Basel Medical Center, Abu Dhabi, Abu Dhabi, United Arab Emirates. Purpose: To investigate gastric accommodation and gastric emptying in patients with functional dyspepsia and normal controls. Methods: Gastric volume was measured by ultrasound taking three dimensions: Londitudinal, transverse and oblique in 20 patients with functional dyspepsia and in 11 normal controls.The following parameters were measured: Fasting water load. Fasting gastric volume. Post drinking water gastric volume. Post drinking water gastric volume change. The ratio of post drinking water gastric volume to fasting gastric volume. These parameters were used for the determination of gastric accommodation. Gastric emptying rate was determined by the formula: post drinking water gastric volume ⫺ post drinking water gastric volume after 25 minutes ⫻ 100. Results: 1. Fasting water load, fasting gastric volume and post drinking water gastric volume were not significantly different in both groups. 2. Post drinking water gastric volume change and the ratio of post drinking water gastric volume to fasting gastric volume were significantly reduced in patients with functional dyspepsia compared to normal controls: (802⫾322 and 585⫾242 0.05 ⬎P⬎0.02 ) and (32.9⫾16.8 and 19.7⫾7.2 0.01⬎ P⬎0.001) respectively. This indicates that gastric accommodation was significantly decreased in patients with functional dyspepsia. Reduced gastric accommodation was observed in 60 % of patients with functional dyspepsia and was significantly reduced in male patients. 3. Post drinking water gastric volume ⫺ post drinking water gastric volume after 25 minutes ⫻ 100 was significantly reduced in patients with functional dyspepsia compared to normal controls (68⫾13.8% and 44.9⫾16.5%) 0.01