Rabeprazole efficacy in erosive GERD: subgroup analyses from the future of acid suppression therapy...
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January 1998 and September 2000. The manometric patterns, the intrarectal and anal residual pressures during straining and their ratio (defecation index) were assessed. Results: A normal pattern consisting of adequate propulsive force and adequate relaxation was seen in 65 (40%) patients. Additionally, three types of abnormal patterns were recognized (fig); Type 1: Adequate propulsive force with inappropriate anal contraction, n 30 (19%); Type II: Inadequate propulsive force with inappropriate anal con- traction, n 46 (29%); Type III: Adequate propulsive force with failure to relax, n 20 (12%). The intrarectal pressure (mmHg, mean SEM) was: 50 3 (normal pattern), 55 4 (Type I), 21 2 (Type II), and 44 3 (Type III). The anal residual pressure was: 28 2 (normal pattern), 79 5 (Type I), 61 6 (Type II), and 44 4 (Type III). The defecation index was: 3 0.6 (normal pattern), 0.7 0.005 (Type I), 0.7 0.3 (Type II), and 1.2 0.1 (Type III). Conclusions: Sixty percent of patients with difficult defecation exhibited abnormal manometry, all of whom had a low (p 0.05) defecation index suggestion of rectoanal incoordination or dyssynergia. Inadequate propulsive force (Type II) is a common phenom- enon in patients with difficult defecation. All three patterns should be considered as diagnostic of dyssynergia. 100 Age, specialty, and practice setting predict GERD prescribing behavior Randal P. Riesett, M.D. 1 , Brian E. Lacy, M.D. 1 * and Amy Mitchell, B.S. 1 , 1 Marvin M. Schuster Motility Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States. Purpose: Gastroesophageal reflux disease (GERD) affects 40% of adult Americans each month. Despite the high prevalence of GERD, and the expense of diagnosing and treating it, little is known about physician behavior in the evaluation and treatment of GERD. Aims: To examine physician patterns of evaluating GERD, and determine the prescribing behavior of different physicians (FP family practice; INT internal medicine; GI gastroenterology) using 8 case scenarios. Methods: 687 physicians in Maryland were randomly identified from medical society lists and professional organizations. An identical 2 page survey was sent to each physician. 1 week later, a reminder postcard was sent. If the questionnaire was not returned within 2 weeks, a second, identical questionnaire was mailed, with a reminder postcard 1 week later. The survey contained 7 demographic questions (age, sex, degree, specialty, practice setting, practice location, years in practice); 8 questions which involved daily practice, and knowledge of published GERD guidelines; and 8 case scenarios which ranged from mild, intermittent GERD Sx, to constant Sx, to the presence of warning signs. Results: 214 questionnaires (31.1%) were returned; 36.3% FP, 29.6% INT; 29.6% GI, 4.7% other. 82% were Male, 18% were Female. Years of practice: 60.5% 15 yrs; 17.6% 11–15 yrs; 15.7% 5–10 yrs; 6.2% 1– 4 yrs. For uncomplicated reflux disease, 77.8% recommended no testing, while 5.9% requested a barium swallow. 8% of FP requested a barium swallow, compared to 6% INT, and 1.6% GI (p .02). In a case with persistent GERD Sx and dysphagia, 52% of FP recommended EGD, as opposed to 69% of INT, and 85% of GI (p .0002). For chronic GERD Sx 5 yrs without warning signs, 82% of GI recommended EGD, while only 45% of FP did (p .0122). The number of years of practice was found to influence prescribing behavior for mild intermittent GERD Sx (p .03), and persistent chronic GERD Sx (p .0017). Physicians 50 yrs of age were significantly (p .038) more likely to prescribe PPIs for mild to persistent GERD Sx, as opposed to physicians age 50. Physicians in an academic setting were more likely to employ step-down therapy in patients with well-controlled GERD Sx on a PPI, as opposed to physicians in an HMO setting. Conclusions: The age, scope of practice (specialty type), number of years in practice, and practice setting were found to significantly affect how patients with GERD were evaluated and treated, using a case scenario questionnaire. Note: This study was funded by the Marvin M. Schuster Motility Center and an unrestricted educational grant from Wyeth-Ayerst. 101 Outcomes of laparoscopic Nissen fundoplications at The Western Pennsylvania Hospital Gilbertas Rimkus, M.D. 1 , Devora E Hathaway, BSN 1 , Daniel J Gagne, M.D. 1 and Philip F Caushaj, M.D., FACG 1 *. 1 Department of Surgery, Temple University School of Medicine Clinical Campus, The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States. Purpose: In the U.S., more than 10% of adults have symptoms of gastro- esophageal reflux disease (GERD). Most patients can be effectively treated with traditional medical management utilizing dietary modification, weight loss, raising the head of the bed, antacids, H2 blockers and proton pump inhibitors (PPI). Although there is minimal literature data comparing PPI and surgical treatment, it seems that long-term relief of GERD may be achieved more efficiently with antireflux surgery or Laparoscopic Nissen fundoplication. Methods: Using retrospective chart review we evaluated outcomes of 29 laparoscopic Nissen fundoplications done at The Western Pennsylvania Hospital between April, 1996 and March, 2001. Outcome evaluation in- cluded reflux symptoms, preoperative and postoperative studies, compli- cations of surgery and need for medical antireflux therapy postoperatively. Results: All patients were diagnosed with GERD preoperatively, 11 pa- tients had hiatel and 4 had paraesophageal hernias. Eighty-four percent of patients were treated with PPI preoperatively. Duration of treatment varied between 1 month and 3 years. No deaths, esophageal injuries, or splenic injuries occured. Average hospital stay was 3 days. Eighty-six percent of patients were symptomatically improved after the surgery. Thirty-four percent of patients had transient postoperative dysphagia. Preoperative symptoms did not correlate with postoperative dysphagia; also there was no correlation between additional procedures preformed with laparoscopic Nissen fundoplication and postoperative symptoms (P 0.05). Three patients had recurrent heartburn postoperatively and required medications, two of them were found to have failed fundoplication and underwernt re-do surgery. Conclusions: Current trends indicate that laparoscopic fundoplication is being used increasingly as an alternative to long-term medical therapy of GERD. Relief of typical reflux symptoms can be anticipated in over 90% of patients undergoing Nissen fundoplication, although mild dysphagia occurs after the procedure, this is transient in most patients. Laparoscopic Nissen fundoplication can be performed safely and effectively in the community hospital setting with all of the advantages of a minimally invasive approach. This can be achieved with a hospital stay of 48 hours and a low incidence of postsurgical complications. 102 Rabeprazole efficacy in erosive GERD: subgroup analyses from the future of acid suppression therapy (F.A.S.T.) trial Malcolm Robinson, MD; Eddie Cheung, MD; Anita Murthy, PharmD; Leonard Jokubaitis, MD Oklahoma Foundation for Digestive Research, University of Oklahoma Health Sciences Center, Oklahoma City, OK. Purpose: To evaluate symptom relief with rabeprazole (RAB) 20 mg in patients with endoscopically diagnosed erosive gastroesophageal reflux disease (GERD). Efficacy was analyzed according to age, gender, esoph- agitis severity, and presence of Barrett’s esophagus (BE). Methods: Open-label RAB 20 mg once daily was given, and patients rated symptom severity at baseline, Days 1 through 7, and Week 4, using a 4-point scale (0 none to 3 severe). Results: From Day 1 through Day 7, all subgroups achieved significant relief of daytime or nighttime heart- S33 AJG – September, Suppl., 2001 Abstracts
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Transcript of Rabeprazole efficacy in erosive GERD: subgroup analyses from the future of acid suppression therapy...
January 1998 and September 2000. The manometric patterns, the intrarectaland anal residual pressures during straining and their ratio (defecationindex) were assessed. Results: A normal pattern consisting of adequatepropulsive force and adequate relaxation was seen in 65 (40%) patients.Additionally, three types of abnormal patterns were recognized (fig); Type1: Adequate propulsive force with inappropriate anal contraction, n � 30(19%); Type II: Inadequate propulsive force with inappropriate anal con-traction, n � 46 (29%); Type III: Adequate propulsive force with failure torelax, n � 20 (12%). The intrarectal pressure (mmHg, mean � SEM) was:50 � 3 (normal pattern), 55 � 4 (Type I), 21 � 2 (Type II), and 44 � 3(Type III). The anal residual pressure was: 28 � 2 (normal pattern), 79 �5 (Type I), 61 � 6 (Type II), and 44 � 4 (Type III). The defecation indexwas: 3 � 0.6 (normal pattern), 0.7 � 0.005 (Type I), 0.7 � 0.3 (Type II),and 1.2 � 0.1 (Type III). Conclusions: Sixty percent of patients withdifficult defecation exhibited abnormal manometry, all of whom had a low(p � 0.05) defecation index suggestion of rectoanal incoordination ordyssynergia. Inadequate propulsive force (Type II) is a common phenom-enon in patients with difficult defecation. All three patterns should beconsidered as diagnostic of dyssynergia.
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Age, specialty, and practice setting predict GERD prescribing behaviorRandal P. Riesett, M.D.1, Brian E. Lacy, M.D.1* and Amy Mitchell,B.S.1, 1Marvin M. Schuster Motility Center, Johns Hopkins UniversitySchool of Medicine, Baltimore, Maryland, United States.
Purpose: Gastroesophageal reflux disease (GERD) affects 40% of adultAmericans each month. Despite the high prevalence of GERD, and theexpense of diagnosing and treating it, little is known about physicianbehavior in the evaluation and treatment of GERD.Aims: To examine physician patterns of evaluating GERD, and determinethe prescribing behavior of different physicians (FP � family practice;INT � internal medicine; GI � gastroenterology) using 8 case scenarios.Methods: 687 physicians in Maryland were randomly identified frommedical society lists and professional organizations. An identical 2 pagesurvey was sent to each physician. 1 week later, a reminder postcard wassent. If the questionnaire was not returned within 2 weeks, a second,identical questionnaire was mailed, with a reminder postcard 1 week later.The survey contained 7 demographic questions (age, sex, degree, specialty,practice setting, practice location, years in practice); 8 questions whichinvolved daily practice, and knowledge of published GERD guidelines; and8 case scenarios which ranged from mild, intermittent GERD Sx, toconstant Sx, to the presence of warning signs.Results: 214 questionnaires (31.1%) were returned; 36.3% � FP, 29.6% �INT; 29.6% � GI, 4.7% � other. 82% were Male, 18% were Female. Yearsof practice: 60.5% �15 yrs; 17.6% � 11–15 yrs; 15.7% � 5–10 yrs; 6.2%� 1–4 yrs. For uncomplicated reflux disease, 77.8% recommended notesting, while 5.9% requested a barium swallow. 8% of FP requested abarium swallow, compared to 6% INT, and 1.6% GI (p � .02). In a casewith persistent GERD Sx and dysphagia, 52% of FP recommended EGD,as opposed to 69% of INT, and 85% of GI (p � .0002). For chronic GERDSx �5 yrs without warning signs, 82% of GI recommended EGD, whileonly 45% of FP did (p � .0122). The number of years of practice was foundto influence prescribing behavior for mild intermittent GERD Sx (p � .03),and persistent chronic GERD Sx (p � .0017). Physicians �50 yrs of agewere significantly (p � .038) more likely to prescribe PPIs for mild topersistent GERD Sx, as opposed to physicians � age 50. Physicians in anacademic setting were more likely to employ step-down therapy in patientswith well-controlled GERD Sx on a PPI, as opposed to physicians in anHMO setting.
Conclusions: The age, scope of practice (specialty type), number of yearsin practice, and practice setting were found to significantly affect howpatients with GERD were evaluated and treated, using a case scenarioquestionnaire. Note: This study was funded by the Marvin M. SchusterMotility Center and an unrestricted educational grant from Wyeth-Ayerst.
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Outcomes of laparoscopic Nissen fundoplications at The WesternPennsylvania HospitalGilbertas Rimkus, M.D.1, Devora E Hathaway, BSN1, Daniel J Gagne,M.D.1 and Philip F Caushaj, M.D., FACG1*. 1Department of Surgery,Temple University School of Medicine Clinical Campus, The WesternPennsylvania Hospital, Pittsburgh, Pennsylvania, United States.
Purpose: In the U.S., more than 10% of adults have symptoms of gastro-esophageal reflux disease (GERD). Most patients can be effectively treatedwith traditional medical management utilizing dietary modification, weightloss, raising the head of the bed, antacids, H2 blockers and proton pumpinhibitors (PPI). Although there is minimal literature data comparing PPIand surgical treatment, it seems that long-term relief of GERD may beachieved more efficiently with antireflux surgery or Laparoscopic Nissenfundoplication.Methods: Using retrospective chart review we evaluated outcomes of 29laparoscopic Nissen fundoplications done at The Western PennsylvaniaHospital between April, 1996 and March, 2001. Outcome evaluation in-cluded reflux symptoms, preoperative and postoperative studies, compli-cations of surgery and need for medical antireflux therapy postoperatively.Results: All patients were diagnosed with GERD preoperatively, 11 pa-tients had hiatel and 4 had paraesophageal hernias. Eighty-four percent ofpatients were treated with PPI preoperatively. Duration of treatment variedbetween 1 month and 3 years. No deaths, esophageal injuries, or splenicinjuries occured. Average hospital stay was 3 days. Eighty-six percent ofpatients were symptomatically improved after the surgery. Thirty-fourpercent of patients had transient postoperative dysphagia. Preoperativesymptoms did not correlate with postoperative dysphagia; also there was nocorrelation between additional procedures preformed with laparoscopicNissen fundoplication and postoperative symptoms (P � 0.05). Threepatients had recurrent heartburn postoperatively and required medications,two of them were found to have failed fundoplication and underwernt re-dosurgery.Conclusions: Current trends indicate that laparoscopic fundoplication isbeing used increasingly as an alternative to long-term medical therapy ofGERD. Relief of typical reflux symptoms can be anticipated in over 90%of patients undergoing Nissen fundoplication, although mild dysphagiaoccurs after the procedure, this is transient in most patients. LaparoscopicNissen fundoplication can be performed safely and effectively in thecommunity hospital setting with all of the advantages of a minimallyinvasive approach. This can be achieved with a hospital stay of 48 hoursand a low incidence of postsurgical complications.
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Rabeprazole efficacy in erosive GERD: subgroup analyses from thefuture of acid suppression therapy (F.A.S.T.) trialMalcolm Robinson, MD; Eddie Cheung, MD; Anita Murthy, PharmD;Leonard Jokubaitis, MD Oklahoma Foundation for Digestive Research,University of Oklahoma Health Sciences Center, Oklahoma City, OK.
Purpose: To evaluate symptom relief with rabeprazole (RAB) 20 mg inpatients with endoscopically diagnosed erosive gastroesophageal refluxdisease (GERD). Efficacy was analyzed according to age, gender, esoph-agitis severity, and presence of Barrett’s esophagus (BE).Methods: Open-label RAB 20 mg once daily was given, and patients ratedsymptom severity at baseline, Days 1 through 7, and Week 4, using a4-point scale (0 � none to 3 � severe). Results: From Day 1 through Day7, all subgroups achieved significant relief of daytime or nighttime heart-
S33AJG – September, Suppl., 2001 Abstracts
burn (HB) (P � 0.001), paralleling all patients enrolled (table). Week 4efficacy was also comparable for these subpopulations.Conclusion: Rabeprazole 20 mg once daily provided effective symptomrelief with only minimal differences noted in relation to age, gender,esophagitis grade, or presence of BE.
Complete Relief-Daytime HB (%)
Complete Relief-Night HB (%)
Subgroup Day 1 Day 7 Day 1 Day 7
Male 67.4 85.2 72.9 88.4Female 59.4 75.5 64.0 82.3�65 years old 61.4 78.8 68.3 84.1�65 years old 73.7 89.4 72.4 90.3Grade 2 61.1 78.0 68.5 84.5Grade 3/4 70.0 86.3 70.9 88.1BE 69.8 84.9 74.3 87.4All patients 64.0 81.1 69.2 85.7
Supported by: Eisai Inc., Teaneck, New Jersey, and Janssen Research Foundation,Titusville, New Jersey.
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Esophageal sensitivity to Barostat balloon distention and Bernsteinacid infusion: which test is best?Sheila Rodriguez-Stanley, PhD1, Sattar Zubaidi, MD1 and Philip BMiner, MD, FACG1*. 1The Oklahoma Foundation for DigestiveResearch, Oklahoma City, OK, United States.
Purpose: There are presumed differences in esophageal receptor activation(ie. mechanical and chemical) in patients that present with esophageal pain.The acceptable standardized clinical tests such as esophagogastroduode-noscopy, 24-h pH monitoring and esophageal manometry (EM) often donot provide an answer for the patient’s pain.Methods: We performed Barostat balloon distention and Bernstein acidinfusion in addition to EM and 24 h pH on 35 patients (9 M, 26F) thatpresented to the GI Lab with various esophageal/gastric complaints. Themodified Bernstein test consisted of intraesophageal infusion of salinefollowed by .1 N HCI (maximum 10 min each). Time to first sensation andpain were recorded. Barostat balloon distention was performed with ahigh-compliance polyethylene balloon (4-cm length, 5-cm diameter, 80-mlmaximum volume) placed 5 cm above the LES. Volume- and pressure-controlled distentions were performed and corresponding sensory and painthresholds were recorded.Results: 51% of patients reported their typical pain with volume-controlledballoon distention and 54% reported their typical pain with less than10-min acid infusion. 34% of patients reported their typical pain with bothballoon distention and acid infusion. Overall, pain with acid infusion wasnot related to pain induced by balloon distention volume (R2 � .0306) orpressure (R2 � .0002). Four patient groups were identified: 1) hypersen-sitive to balloon and acid (pain with � 5 min acid infusion and � 22 mlballoon distention), 2) hypersensitive to balloon (� 22 ml balloon disten-tion), 3) hypersensitive to acid (pain with � 5 min acid infusion), and 4)hypersensitive to neither.Conclusions: Pain induced by the Bernstein and Barostat can identifypatients with different sensory pathways for their esophageal pain such as1) mechano- and chemo-sensitive, 2) mechano-sensitive, 3) chemo-sensi-tive, and 4) neither (pain of unknown origin). Our data suggest that bothBernstein acid infusion and Barostat balloon distention are necessary teststo assess esophageal hyperalgesia.
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Extraesophageal reflux symptoms reversed by anti reflux procedure:strettaAlvaro Reymunde,M.D., FACG 1* and Nilda Santiago,M.D.1. 1PonceGastroenterology Research, Ponce, Puerto Rico, Puerto Rico.
Purpose: To observe if resolution of gastroesophageal reflux by means ofthe stretta procedure, in patients with reflux associated bronchial asthma, asdetermined by their pneumologist and confirmed by the gastroenterologist,results in significant improvement of the asthma.Methods: Patients who met the criteria for reflux induced bronchial asthmaas evidenced by pulmonary function tests, 24 hr pH monitoring and upperendoscopy were offered the stretta procedure. After the procedure theywere followed for up to 8 months, to assess symptom improvementResults: Six patients met the criteria. All of them were using twice dailyPPI’s, plus �agonists/steroids, as prescribed by their pulmonologist/gas-troenterologist. The six patients underwent the stretta procedure withoutany complications. One month after the procedure the patients were able todiscontinue use of PPI’s and had decreased their need for bronchial asthmamedications to a minimum. After up to 8 months of follow up, none of thepatients has required hospital admission due to exacerbated asthma.Conclusions: The stretta procedure for gastroesophageal reflux disease canbe of great benefit for those patients with reflux induced bronchial asthma,decreasing the need for medications and hospital admissions, thus the costof treating this disease.
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Stretta procedure: A good and cost effective alternative to long termproton pump inhibitors; A clinical experience after 82 consecutiveproceduresAlvaro Reymunde, M.D., FACG1* and Nilda Santiago, M.D.1. 1PonceGastroenterology Research, Ponce, Puerto Rico, Puerto Rico.
Purpose: To evaluate the success of the stretta procedure in patients withclassic symptoms of gastroesophageal reflux disease as measured by symp-tomatic improvement and need for medication.Methods: Patients were evaluated for possible stretta procedure and se-lected according to the following citeria: daily reflux symptoms with classicheartburn, needing daily use of PPI’s for � 1 year, in addition to observinga strict antireflux diet. Patients with evidence of hypersecretory states orbaseline endoscopic evidence of esophagitis � 1 or presence of Barrett’swere excluded. The stretta procedure was performed by a single endosco-pist, on an ambulatory basis. The patients were followed for a mean periodof 4 months. They were evaluated on the basis of the need to continueobserving antireflux diet and lifestyle modifications, and symptomaticimprovement. Quality of life pre and post procedure were also evaluated.Results: 150 patients were evaluated. 82 patients underwent the procedure.Seventy five percent of those had non erosive esophagitis and 25% esoph-agitis grade 1. Four weeks after the procedure, 97% of the patients wereable to discontinue the use of PPI’s and were instructed to use only Tumsat bedtime. They were also able to return to a normal unrestricted diet. Thepatient’s quality of life improved by 70% in those patients, now that theyhad no dietary restrictions and no need for daily medication. There were noserious adverse events and patients only complained of mild chest discom-fort during the first 24 hours after the procedure, which did not require theuse of any pain relief medication.Conclusions: The stretta procedure is a safe and well tolerated procedurewhich has proven to be effective in the treatment and improvement ofquality of life in patients with classic GERD. Since it is well known thatthere is usually no progression in the degree of esophagitis from baselineEGD (according to a 15 year follow up study) and the aim of our study wasto measure symptom improvement we followed the same apporach used inclinical practice, to treat GERD symptoms in patients without alarm signsand if the patients become asymptomatic not to test for possible changes inpH.
S34 Abstracts AJG – Vol. 96, No. 9, Suppl., 2001
