Comparison of transnasaly placed wireless pH capsule (BRAVO®) versus traditional 24-hour esophageal...

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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 mini- mum of 3 months, and occurring 2 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%, PNS) and acid regurgitation (Eso 60% vs Lanso 65%, PNS). 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 popula- tion. 108 COMPARISON OF TRANSNASALY PLACED WIRELESS PH CAPSULE (BRAVO) 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) 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. Pa- tients were randomized to the traditional pH probe, or to transnasaly placed wireless pH capsule. During the test the patients recorded their activities, 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 49.33.3, 9M) were randomized to the traditional pH, and 15 (mean age 52.82.1, 6M) to the wireless capsule. Percent total time pH4 was not different between the groups on and off PPI (pNS). 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 (p0.05). Alcohol, coffee consump- tion, 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 (p0.03, p0.001, p0.02, p0.001, respec- tively). However, during insertion of the capsule, 86% of patients experi- enced mild and transient nosebleed. Patients in the wireless capsule group perceived the study as less interfering with their overall daily activities and sleep (p0.006 and p0.03, 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 (p0.0001, p0.005 respectively). Significantly more patients in the wire- less 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 (p0.02). Conclusions: Transnasaly placed wireless pH capsule is significantly bet- ter 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 di- mensions: 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 accommo- dation. 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: (802322 and 585242 0.05 P0.02 ) and (32.916.8 and 19.77.2 0.01 P0.001) 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 dys- pepsia compared to normal controls (6813.8% and 44.916.5%) 0.01 S38 Abstracts AJG – Vol. 98, No. 9, Suppl., 2003

Transcript of Comparison of transnasaly placed wireless pH capsule (BRAVO®) versus traditional 24-hour esophageal...

Page 1: Comparison of transnasaly placed wireless pH capsule (BRAVO®) versus traditional 24-hour esophageal pH monitoring-a randomized trial

reversal. Thus, an abnormal baseline 24 hr pH is significantly predictive ofthe need for increased PPI dose during endoscopic ablation of BE.

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ONCE-DAILY ESOMEPRAZOLE AND TWICE-DAILYLANSOPRAZOLE IN CONTROLLING EPIGASTRIC PAIN ANDACID REGURGITATION IN PATIENTS WITH RESISTANTGERDRonnie Fass, M.D., FACG*, Barry M. Traxler, B.S.,Samisha Thomas, B.A., Mark B. Sostek, M.D. University of ArizonaHealth Sciences Center, Tucson, AZ and AstraZeneca LP, Wilmington,DE.

Purpose: In clinical practice there is a tendency to use increased doses ofa proton pump inhibitor if the desired clinical response is not achieved withthe standard dose. The purpose of ths study was to compare the symptomrelieving effects of esomeprazole (Eso) 40mg once daily (qd) to those oflansoprazole (Lanso) 30mg twice daily (bid) on epigastric pain and acidregurgitation 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 GERDtaking Lanso 30mg qd with a history of heartburn symptoms for a mini-mum of 3 months, and occurring �2 days per week on average, wereeligible for enrollment. Eligibility was confirmed by completing a symptomdiary during a 2-week run-in period while taking Lanso 30mg qd. Eligiblepatients were randomized to Eso 40mg qd or Lanso 30mg bid for 8 weeks.Episodes of epigastric pain and acid regurgitation were recorded daily in apatient diary throughout the 8 weeks of treatment. The percentages ofsymptom-free days post washout from Lanso 30mg qd to the end oftreatment were analyzed from diary data using an analysis of covariancemodel (ANCOVA) from which the least-squared mean estimates wereobtained for the 2 treatments. The study was powered to statistically ruleout 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 theEso and Lanso groups, respectively. The percentage of symptom-free daysduring the study period was similar between treatment groups for bothepigastric pain (Eso 65% vs Lanso 67%, P�NS) and acid regurgitation(Eso 60% vs Lanso 65%, P�NS). Changes from baseline in weeklyaverage symptom severity scores during treatment were virtually identicalbetween the two treatments, and similar proportions of patients in eachgroup showed symptom improvement from baseline during the final weekon treatment. Both treatments were well tolerated.Conclusions: Eso 40mg qd provides clinically similar effects to Lanso30mg in controlling epigastric pain and acid regurgitation in patients withGERD resistant to treatment with Lanso 30mg qd. Eso therapy may providean opportunity to avoid Lanso bid therapy in this difficult patient popula-tion.

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COMPARISON OF TRANSNASALY PLACED WIRELESS PHCAPSULE (BRAVO�) VERSUS TRADITIONAL 24-HOURESOPHAGEAL PH MONITORING-A RANDOMIZED TRIALRoy 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�) can be placed either duringendoscopy or transnasaly. However, for open-access motility laboratories,the latter technique is more relevant. Our aim was to compare the feasibilityand tolerability of transnasal placement of the wireless pH capsule versusthe traditional pH probe.Methods: Consecutive patients referred for a pH test were enrolled. Pa-tients were randomized to the traditional pH probe, or to transnasaly placedwireless pH capsule. During the test the patients recorded their activities,

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 transnasalcapsule placement and were crossed-over to the pH probe). Seventeenpatients (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 timepH�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. Whilethere was no difference in the number of meals between groups, patientswith the wireless capsule spent significantly more time eating breakfastthen those with the traditional probe (p�0.05). Alcohol, coffee consump-tion, 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 thetraditional pH probe group (p�0.03, p�0.001, p�0.02, p�0.001, respec-tively). However, during insertion of the capsule, 86% of patients experi-enced mild and transient nosebleed. Patients in the wireless capsule groupperceived the study as less interfering with their overall daily activities andsleep (p�0.006 and p�0.03, respectively). Patients in the wireless capsulegroup were significantly less bothered by the test and rated their overallsatisfaction as better as compared to those with the traditional probe(p�0.0001, p�0.005 respectively). Significantly more patients in the wire-less capsule group stated that they would be willing to undergo the testagain if necessary, as compared to those in the traditional pH probe group(p�0.02).Conclusions: Transnasaly placed wireless pH capsule is significantly bet-ter tolerated then the traditional pH probe. Consequently, it is an attractivemodality for open-access motility laboratories.

STOMACH

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GASTRIC ACCOMMODATION AND GASTRIC EMPTYING INPATIENTS WITH FUNCTIONAL DYSPEPSIAMohamed N.A. Al-Aghbar, Ph.D.*. Basel Medical Center, Abu Dhabi,Abu Dhabi, United Arab Emirates.

Purpose: To investigate gastric accommodation and gastric emptying inpatients with functional dyspepsia and normal controls.Methods: Gastric volume was measured by ultrasound taking three di-mensions:

Londitudinal, transverse and oblique in 20 patients with functionaldyspepsia and in 11 normal controls.The following parameters weremeasured:

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 accommo-

dation.Gastric emptying rate was determined by the formula: post drinking

water gastric volume � post drinking water gastric volume after 25minutes 100.

Results: 1. Fasting water load, fasting gastric volume and post drinkingwater gastric volume were not significantly different in both groups. 2. Postdrinking water gastric volume change and the ratio of post drinking watergastric volume to fasting gastric volume were significantly reduced inpatients with functional dyspepsia compared to normal controls: (802�322and 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 wassignificantly decreased in patients with functional dyspepsia. Reducedgastric accommodation was observed in 60 % of patients with functionaldyspepsia and was significantly reduced in male patients. 3. Post drinkingwater gastric volume � post drinking water gastric volume after 25minutes 100 was significantly reduced in patients with functional dys-pepsia compared to normal controls (68�13.8% and 44.9�16.5%) 0.01

S38 Abstracts AJG – Vol. 98, No. 9, Suppl., 2003