Patient satisfaction with the Bravo pH probe monitoring system

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Abstracts

AJG – Vol. 98, No. 9, Suppl., 2003

Response to Dilatation at 1 mo: The Before and After Gp A ( 54 Fr) Baseline DS DS at 1 mo Baseline VAS VAS at 1mo

3.8 ⫾ 1.0 3.1 ⫾ 1.4 4.5 ⫾ 0.8 6.0 ⫾ 1.7 n⫽7

Gp B ( 24 Fr/Placebo) 3.6 ⫾ 0.9 2.8 ⫾ 1.1 3.4 ⫾ 1.9 5.1 ⫾ 1.9 n⫽ 9

p⫽ 0.18 ( NS) p⫽ 0.15 ( NS)

p⫽0.11( NS) p⫽0 .41(NS)

Conclusions: In a small minority of patients, severe odynophagia necessitates endoscopic dislodgement of the Bravo capsule. All patients in this series had refractory or atypical symptoms, often pain, that had minimal assocation with reflux events on the pH study. Dislodgement of the device with a snare (without electrocautery) is advisable if initial attempts at gentle pressure with the endoscope are unsuccessful, as endoscopic pressure alone may result in stripping of the esophageal mucosa and bleeding.

Fr⫽ French dilator, DS⫽ Dysphagia Score, VAS⫽ Visual Analogue Scale

97

Response to Dilatation at 3 mos: The Before and After Gp A (54 Fr) Baseline DS DS at 3 mos Baseline VAS VS at 3mos

4.0 ⫾ 1.0 2.8 ⫾ 1.4 4.6 ⫾ 0.8 3.1 ⫾ 2.4 n⫽6

Gp B (24 Fr/Placebo) p⫽0.06 (NS) p⫽0.10 (NS)

3.6 ⫾ 0.9 2.4 ⫾ 0.7 6.1 ⫾ 1.9 4.1 ⫾ 2.7 n⫽7

p⫽0.016* p⫽0.013*

Fr⫽ French Dilator, DS⫽ Dysphagia score, VAS⫽ Visual Analogue Scale, *⫽ Statistically significant

Conclusions: Results of our prospective study do not support the practice of empiric dilatation in patients with symptoms of dysphagia and a normal upper endoscopy.

96 ENDOSCOPIC REMOVAL OF THE BRAVO PH CAPSULE BECAUSE OF SEVERE ODYNOPHAGIA Sreenivasa Jonnalagadda, M.D., Chandra Prakash, M.D., Riad Azar, M.D., Laura Haroian, R.N., Ray E. Clouse, M.D., FACG*. Washington University School of Medicine, Saint Louis, MO and Barnes–Jewish Hospital, Saint Louis, MO. Purpose: Bravo pH monitoring is an innovative wireless system that allows ambulatory assessment of esophageal acid exposure using a radiotelemetery capsule. The device is attached to the distal esophagus by deployment of a locking pin through esophageal mucosa that has been pulled by suction into a small cup in the side of the capsule. Typically patients have minimal discomfort while the device is attached, and it eventually sloughs from the mucosa spontaneously. We reviewed clinical features and outcomes of patients who required endoscopic dislodgement of the device to determine predisposing characteristics and optimal methods for removal. Methods: Our institutional database was queried to identify patients who required endoscopic removal of the Bravo capsule. Clinical characteristics, management methods, and outcomes were extracted from endoscopy reports, clinical data forms, and pH study results. Results: A total of 118 patients underwent pH monitoring with the Bravo system over a 21 month period. 4 (3.4 %) required upper endoscopy for removal of the capsule because of severe symptoms within 2-8 days of attachment.

Pt # 1 2 3 4

Indication for study Refractory heartburn Chest pain Chest pain, cough Chest pain

Reason for removal Severe Severe Severe Severe

odynophagia odynophagia odynophagia odynophagia

ESOMEPRAZOLE AS MAINTENANCE THERAPY IN EROSIVE ESOPHAGITIS: A QUANTITATIVE ASSESSMENT OF EFFICACY USING AN EVIDENCE-BASED APPROACH David A. Johnson, M.D., FACG*, Paul E. Hoyle, Ph.D., Barry M. Traxler, B.S., Douglas Levine, M.D., FACG, Karsten Lauritsen, M.D. Eastern Virginia School of Medicine, Norfolk, VA; AstraZeneca LP, Wilmington, DE and Odense University Hospital, Odense, Denmark. Purpose: Esomeprazole (Eso) 20 mg has been shown to maintain significantly higher remission rates in patients with healed erosive esophagitis (EE) than Lanso 15 mg. Evidence-based techniques were applied to clinical trial data of Eso as maintenance therapy to provide a practical, quantitative analysis of its efficacy relative to Lanso. Methods: Patients with a history of heartburn and EE, LA grade A–D at baseline, received Eso 40 mg once daily for up to 8 weeks for healing. Those with healed EE were randomized to receive once daily Eso 20 mg (n ⫽ 615) or Lanso 15 mg (n ⫽ 609) for up to 6 months. For this retrospective analysis, the number needed to treat (NNT), the reciprocal of the absolute risk reduction (ARR) was calculated at 6 months for all patients and for subgroups with mild disease (LA Grade A or B) and severe disease (LA Grade C or D). Results: See table. As the severity of disease increased the NNT to prevent one relapse that may otherwise have occurred with Lanso decreased. LA Grade of EE

Number of patients (Eso/Lanso)

ARR (Eso/Lanso)

NNT (95% CI)

All Grades A–B mild C–D severe

615/609 501/507 114/102

0.09 0.07 0.16

11.1 (11.07–11.16) 13.5 (13.41–13.50) 6.1 (5.94–6.19)

Conclusions: Maintenance of remission of EE is an important therapeutic goal for patients with GERD. In this evidence-based analysis, it was determined that 11 patients with EE would need to be treated with Eso to prevent one treatment failure that otherwise may occur with Lanso regardless of the baseline grade of EE. For patients with more severe disease, the NNT was lower, indicating a greater likelihood of therapeutic success with Eso versus Lanso. Because relapse of EE is difficult to predict based on symptoms alone and may occur even in the absence of recurrent heartburn, the most effective treatment provides the most assurance that healing will be maintained. This evidence supports Eso as an effective treatment for maintenance of remission and prevention of treatment failure in GERD patients with EE.

Time after placement (days)

Symptom index

98

6 4 2 8

4% (5/123) 3% (1/30) 0% (0/9) 6% (3/48)

PATIENT SATISFACTION WITH THE BRAVO PH PROBE MONITORING SYSTEM Ayaz Chaudhary, M.D., Douglas Lowe, M.D., Andrew Guidroz, M.D., Robert R. Schade, M.D., FACG*. Medical College of Georgia, Augusta, GA and Veterans Administration Medical Center, Augusta, GA.

In one patient (#2), the capsule was easily dislodged with the tip of the endoscope. In the other three patients, initial attempts to dislodge the capsule with the endoscope tip resulted in esophageal mucosal stripping and minor hemorrhage without actual dislogement. Epinephrine injection was used in one patient to achieve hemostasis. In each of these 3, a snare (without electrocautery) was used to successfully detach the device. Dislodgement resulted in prompt resolution of odynophagia and return to baseline symptom level in each patient.

Purpose: Conventional pH monitoring using nasoesophageal pH probes often results in nasopharyngeal discomfort, is socially unpleasing, and causes the patient to restrict daily activities resulting in days lost from work and limitation in social function. This may also change eating and sleeping patterns that could affect the pH results.

AJG – September, Suppl., 2003

Methods: The following questions were asked to 10 of 20 patients who received the Bravo Probe: 1. What was your overall opinion of your experience with the BRAVO system? 2. Did you experience any chest pain immediately after placement of the device? After 1 hour? 3. Did you experience any difficulty swallowing after the device was placed? If so was difficulty experienced with liquids, solids, or both? Severity? 4. Did eating feel different? 5. Did you experience restriction in your daily activities? How severe was the restriction? 6. Did you go to work the day following the procedure? 7. Did you continue to attend social events on the day of the test and the following day? 8. Do you think you were able to tell when the capsule fell from the wall of the esophagus? 9. Would you recommend this test to other patients? 10. Would you prefer to have the BRAVO system or the standard nasoesophageal pH probe? Answers were graded on a 5 point scale with higher numbers representing a more positive experience. Results: In terms of the patient’s overall experience with the procedure, 40% rated it as 5/5, 40% as 3/5, 10% as 2/5, and 10% as 1/5. Chest pain was experienced immediately in 2 patients and in 1 after one hour. Difficulty swallowing was perceived in 30% (10% solids only and 20% solids and liquids) and eating felt different in 20%. Of the five people that worked, 80% were able to return to work on the day following the procedure. Social events continued in 80%. When compared to a description of the conventional test, 90% would prefer the BRAVO system, and 90% would recommend the test to other patients. The one patient who rated the test 1/5 also did not tolerate conventional pH probe testing. Conclusions: The BRAVO pH monitoring system is preferred by patients over conventional testing. Capsule placement had minimal effects on activities including work. We suggest that use of the BRAVO system could prove to be cost effective since most patients are able to continue their work and other activities with the system in place. It may also result in detection of more reflux episodes as a result of more normal activity.

99 CAN HELICOBACTER PYLORI STATUS PREDICT SEVERITY OF ESOPHAGITIS? Alvaro Reymunde, M.D.*, Jose Rivera, M.D., Nilda Santiago, M.D. Ponce Gastroenterology Research, Ponce, PR. Purpose: Correlate the degree of severity of esophagitis with H. pylori infection expecting that the more severe the esophagitis, the lower the incidence of H. pylori infection. Methods: Endoscopies were performed on patients with history of GERD and the degree of esophagitis was assessed using the LA Clasification Scale. Helicobacter pylori status was assessed by serology using the Flex Sure HP test and confirmed by histoloy from gastric biopsies taken at the time of endoscopy. The degree of esophagitis was then compared with H. pylori testing results to evalaute the presence of a correlation between the two. Results: Of a total of 25 patients, 20 had endoscopic evidence of esophagitis. The patients were matched for sex (10:10) and ages ranged from 23 to 64 (mean, 46.15). Severity of esophagitis ranged from Grade A (2 patients), Grade B, ( 5 patients), Grade C (10 patients) and Grade D (3 patients). Out of the twenty, only 4 patients tested positive for H. pylori. Of these, one had esophagits Grade B, two had Grade C and one had Grade D. A statistically significant relationship between the degree of esophagits and helicobacter pylori infection could not be established. We did not find any difference in prevalence of H. pylori infection in esophagitis patients when compared to normal population.

Abstracts

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Conclusions: Patients with relfux esophagitis do not present a higher incidence of Helicobacter pylori infection than the normal population. There is not a significant relationship between the precence of Helicobacter pylori and severity of esophagitis.

100 ESOMEPRAZOLE 40MG ONCE DAILY AND LANSOPRAZOLE 30MG TWICE DAILY FOR HEARTBURN SYMPTOMS 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: Esomprazole (Eso) is the first proton pump inhibitor (PPI) to show improved efficacy over lansoprazole (Lanso) for the treatment of erosive esophagitis. The purpose of this study was to compare the effects of Eso 40mg once daily (qd) and Lanso 30mg twice daily (bid) on symptom control in patients with gastroesophageal reflux disease (GERD) with heartburn symptoms resistant to 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. A maximum of 6 antacid tablets per day were allowed as rescue medication for relief of acute GERD symptoms. Patients recorded daily heartburn severity in a diary using a 4-point scale 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 pre-specified 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 heartburn-free days during the study period was 54.4% and 57.5% for the Eso and Lanso groups, respectively (p⫽0.39). Differences in symptom scores were virtually identical between the two treatments (p⫽0.98), and 83.3% of patients in each group showed improvement in heartburn symptom scores. Mean rescue antacid consumption was similar (Eso 0.4, Lanso 0.5 tablets/day). Both treatments were well tolerated. Conclusions: Eso 40mg qd is clinically similar to Lanso 30mg bid in controlling heartburn symptoms in patients with GERD resistant to treatment with Lanso 30mg qd. Once daily Eso provides an alternative to Lanso bid in this challenging patient population. 1. Castell DO et al. Am J Gastroenterol 2002;97(3):575–583.

101 DOES BACLOFEN DECREASE ACID REFLUX AND CLINICAL SYMPTOMS IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE? A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL Mark J. Cossentino, M.D., Corinne Maydonovitch, Lavern Belle, Roy K.H. Wong, M.D.* Walter Reed Army Medical Center, Washington, DC and Uniformed Services University of the Health Sciences, Bethesda, MD. Purpose: To compare the effect of the GABAB agonist baclofen versus placebo in treating GER as measured by (1) 24-hour pH monitoring and (2) clinical symptoms.