AGA Abstracts Mo1136 Mo1137
The Effect of Swallowing on Esophageal Basal Impedance Measurement Using 24 hr Esophageal pH Impedance Monitoring in Patients With Typical Refluxes Symptoms and No Esophagitis Suppakorn Malikhao, Tanisa Patcharatrakul, Sutep Gonlachanvit
Use of a Sleep Positioning Device Significantly Improves Nocturnal Gastroesophageal Reflux Symptoms Sanath Allampati, Rocio Lopez, Prashanthi N. Thota, Monica Ray, Sigurbjorn Birgisson, Scott L. Gabbard
Basal esophageal impedance measurement has been reported as a good diagnostic tool for GERD. To investigate the effect of swallows, meal ingestion and sleep periods on basal esophageal impedance, patients with typical GERD symptoms and no esophagitis who underwent 24 hr esophageal impedance - pH monitoring during off treatment using the VersaFlex® Z pH-impedance catheter and the Omega®, MMS system were included. The basal impedance level was the average values of 30 second-periods at the distal impedance channel, excluding periods of meal ingestion, swallows, belching and gastroesophageal refluxes. Basal impedance levels and swallow frequency were measured every 30 min during the entire recoding periods. Complete and incomplete saliva swallowing were defined as bolus entry followed by bolus clearance at all impedance recording sites and by failure bolus clearance in the two distal recording sites, respectively. Result: 23 consecutive patients with positive pH test(12F, 50 ±14 yr, BMI 26.9±5.0 kg/m2) and 23 patients with negative pH test(14F, 52±13yr, BMI 23.5±3.3 kg/m2, randomly selected from the patients who had typical reflux symptoms and negative pH test during the same study period) were included. The rate of total swallows during the 24 hr study period was similar between patients with positive and negative pH test, respectively (7.5±5.9vs.7.0±5.1 time/hr, p>0.05). The mean basal impedance during the entire study period was significant lower in patients with positive vs. negative pH test (1836±218 vs. 2866±350V , p<0.05). The basal impedance levels had a significantly positive correlation with total (r=0.26, p<0.05) and complete swallowing rate (r=0.3, p<0.05) in the whole 46 patients and both positive (total swallows r=0.38, p<0.05, complete swallows r=0.46, p<0.05) ) and negative pH groups (r = 0.38 and 0.37 respectively, p<0.05). Immediately after meal ingestion the basal impedance level and swallowing rate were significantly higher(3478±947V and 16.9±5.9 time /hr during 0-30 min after meal) compared to before meal (2022±670V and 3.4±2.1 time/hr) (p<0.05) and both basal impedance and swallowing rate gradually decreased over time (during 30-60 min were 2832±705V and 11.8±4.4 time/hr and 60-90 min after meal were 2280±712V and 6.9±3.2 time/hr). The basal impedance and swallowing rate of sleep-time period were significant lower than non sleep- time period (1625±603V vs.2286±660V, p<0.05 and 1.9±1.5 vs.7.5±6.4 time/hr, p<0.05). Conclusion: Swallow, meal ingestion, sleep and acid reflux status are significantly influence basal esophageal impedance level. The lower basal impedance during sleep and higher basal impedance after meal ingestion seems to be the effect of decrease and increase swallowing rate, respectively. This study suggest that control swallowing rate could optimize the measurement of esophageal basal impedance in shorter duration.
Purpose: A recent study demonstrated a decrease in nocturnal acid exposure and reflux episodes in healthy volunteers who slept using a sleep positioning device (SPD) consisting of a two-component incline base (9 inches in height) and a lateral positioner body pillow (Medcline, Amenity Health Inc., San Diego, CA). The purpose of this study is to determine if the use of this SPD decreases nocturnal symptoms in patients with GERD. Methods: This is a single center prospective trial involving patients on anti-secretory medications with continued frequent moderate to severe nocturnal heartburn and regurgitation. Patients completed the Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ) and GERD health related quality of life questionnaire (GERD-HRQL) at enrollment. The NGSSIQ and GERD-HRQL are validated questionnaires and N-GSSIQ is comprised of three parts (nocturnal GERD symptoms, morning impact of GERD and concerns about nocturnal GERD). Patients were instructed to sleep on the SPD for at least 6 hours a night during the two week study period, patients were instructed to continue their baseline anti-secretory medication dose. At the end of the two week trial, the questionnaires were repeated. All analyses were performed using SAS (version 9.4, The SAS Institute, Cary, NC). Results: A total of 25 patients (14 female and 11 male; age 58.4±13.4) were recruited from an outpatient Gastroenterology clinic. 24 patients were currently taking proton pump inhibitor (PPI), one patient (intolerant to PPI) was taking H2 receptor antagonist (H2RA). NGSSIQ scores significantly improved over baseline after 2 weeks of SPD use (mean 54.6 [pre] vs. 17.0 [post], p < 0.001). Significant improvement was also noted in all three subsets of the NGSSIQ: nocturnal GERD (33.6 vs. 9.3, p < 0.001), morning impact of nocturnal GERD (6.2 vs. 2.2, p < 0.001) and concern about nocturnal GERD (14.7 vs. 5.5, p < 0.001). 16 patients completed the GERD-HRQL questionnaire, significant improvement was also noted (28.4 vs. 16.3, p < 0.001). No adverse events were reported. Conclusion: In patients with nocturnal heartburn and regurgitation despite anti-secretory medication use, the Medcline SPD significantly reduced nocturnal GERD symptoms, morning impact of nocturnal GERD, concern about nocturnal GERD and helped improve health related quality of life after two weeks of use.
Figure 1: Improvement in GERD symptoms after use of SPD Mo1138 The Pharmacokinetics and Pharmacodynamics of Dexlansoprazole OrallyDisintegrating Tablet Michael Kukulka, Sai Vamshidhar Nudurupati, Maria Claudia Perez Introduction: The proton pump inhibitor dexlansoprazole (DEX) is administered as a modified release (MR) formulation consisting of 2 types of granules within a single capsule. DEX delayed-release capsules are approved for use in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), healing of erosive esophagitis (EE), and maintenance of healed EE and relief of heartburn. Since some patients are unable or unwilling to swallow capsules, a DEX delayed-release orallydisintegrating tablet (OD) has been developed. DEX OD contains 2 types of granules that release drug in a pH-dependent manner in order to extend DEX plasma concentrations. Objective: To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of DEX OD 30 mg and DEX MR 30 mg capsule. Methods: This was a randomized, multiple-dose, 2period crossover study. Healthy subjects 21-55 years old received 30 mg DEX OD or capsule