- Email: [email protected]
The future of acid suppression therapy trial with rabeprazole: preliminary analysis of acute symptom relief
AJG – September, 2000
toxin (1 ml aliquots) in each quadrant (total 80 –100 units) using 25 gauge Variject sclerotherapy needle (Microvasive, Milford, MA) followed by positioning of 25 mm size 8 cm long TTS anastomotic balloon catheter (Microvasive, MA) and inflating up to specified PSI/Atm for 30 seconds. All patients had LES pressure measurements at the end of procedure and were followed up by scintigraphic esophageal clearence study and/or manometry after 6 months. Results: All 9 patients had successful dilatation and BOTOX injection and tolerated procedure well. The TTS balloon dilatation was simple and easy to perform and no perforations or other complications were noted. The follow-up period ranged from 3–18 months. All nine patients had significant improvement in their swallowing ability and symptom score. LES pressures prior to therapy were in the range of 30 – 60 mmhg and dropped to ⬍25 mmhg in all cases. 4 patients underwent therapy ⬎15 months ago and did not require any additional treatment so far. Conclusions: Our preliminary experience suggests that combination therapy using BOTOX injection and 25 mm TTS balloon dilatation therapy is effective and durable for treatment of achalasia. However a larger study and long term followup will be required to determine if this method is superior to either BOTOX injection or 30 –35 mm pneumatic dilatation alone. 43 Report of a case illustrating the dilemma of primary esophageal pseudodiverticulosis with colonization of candida vs. recurrent esophageal candidiasis leading to pseudodiverticulosis Surya P Irakam, C Kunavarapu, M Hasan, F Marsh, M Cerulli*. Interfaith Medical Center, Brooklyn Hospital Center, Brooklyn, NY, United States. Purpose: Candidal Esophagitis remains the most important and at times most difficult differential diagnostic consideration in patients with diffuse intramural esophageal pseudodiverticulosis. It’s role as primary pathogen remains to be studied. Methods: Here we are reporting an interesting case illustrating the dilemma. Results: A 33 year old B/F with H/O HIV Disease was seen in ER with dysphagia in Nov, 1997 and Endoscopy showed typical whitish plaques lining esophagus and biopsy confirmed candidiasis. She responded symptomatically to fluconazole initially. After a few months her symptoms recurred, she refused repeat endoscopy persistently. As an alternative esophagogram was done, which showed shaggy appearance of mucosa, highly suggestive of candidiasis and she was started on Amphoterecin B for presumed fluconazole resistant candidiasis, but no response was seen. After several visits and admissions, she accepted for EGD in Dec 98, which showed multiple small diverticuli in linear fashion mainly in middle 1/3 and lower 1/3 of esophagus. Smear and histology did not reveal candidiasis. Her symptoms never progressed, in spite of discontinuing Amphoterecin. Conclusions: Our case illustrates the dilemma of which is first, pseudodiverticulosis (leading to colonization of candida) or chronic candidiasis (leading to pseudodiverticuli formation). 44 Technical feasibility of ambulatory pH monitoring for esophagopharyngeal and gastroesophageal acid reflux Abdul Jabbar, MD, Zarina Mohiuddin, Brian Hawkins, MD, Mark Wilson, MD, Debbie Huff, RN, John Wo, MD. University of Louisville, Louisville, KY. Ambulatory pH testing is considered very reliable for distal esophageal reflux (DR), but technical aspects of detecting esophagopharyngeal reflux (EPR) is unclear. Purpose: To compare technical feasibility between pharyngeal and esophageal pH testing. Methods: 101 consecutive 24-hr dual-sensor pH tracings (46 EPR/55 DR) were evaluated. Dual-sensors were placed in the pharynx & proximal
Abstracts
2423
esophagus for EPR and proximal & distal esophagus for DR. Tracings were read randomly with the interpreter blinded to pt’s name, symptoms and type of monitoring. Proximal reflux episode was defined when: 1) nadir has pH ⬍ 4, 2) abrupt drop in pH (onset to nadir in ⬍30 seconds) and 3) pH drop during distal sensor pH ⬍ 4. The following artifacts were defined prospectively; type 1: out of range (pH ⫽ 0 or ⬎9), type 2: pH drift (onset of pH drop to nadir ⬎30 seconds) and type 3: isolated pH drop (proximal sensor pH ⬍ 4 without distal pH ⬍ 4). Overall results were calculated before and after exclusion of artifacts. Results: No significant differences in artifacts were detected between EPR and DR (see table). Conclusions: 1) Type and duration of pH artifacts were similar between EPR and DR pH testing. 2) Changes in total acid exposure after excluding artifacts are minimal. 3) pH testing in the pharynx is as technically feasible as in distal esophagus.
Study duration (median) Total # of artifacts # of type 1 artifacts # of type 2 artifacts # of type 3 artifacts # of artifacts/study* Total time of artifacts/study* # of studies with no artifacts Total % time pH ⬍ 4 before adjustment* Total % time pH ⬍ 4 after adjustment*
EPR pH testing
DR pH testing
22 hrs 55 mins 119 29 (24%) 31 (26%) 61 (50%) 1 (0–17) 3 mins (0–423) 14 (30%) 0.6% (0–28) 0.5% (0–8.5)
22 hrs 43 mins 41 35 (25%) 31 (22%) 75 (53%) 1 (0–15) 2 mins (0–159) 23** (42%) 5.4% (0–34) 5.1% (0–34)
* presented as median (range), ** no difference by chi square test.
45 Does Helicobacter pylori infection have a role in the pathogenesis of reflux esophagitis? Seong Gook Jeon, Yi Kyung Chun. Samsung Cheil Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. Purpose: Whether Helicobacter pylori infection protects against reflux esophagitis is controversial. The aim of the present study is to investigate the role of Helicobacter pylori infection in the pathogenesis of reflux esophagitis. Methods: Forty-two consecutive patients (male:female ⫽ 15:28, mean age: 48 yr) with reflux esophagitis on EGD were studied. Sex and age matched, 39 asymptomatic subjects who underwent EGD for regular physical check-up were used as a control group. Exclusion criteria included the use of antibiotics within 30 days before EGD, prior gastric or esophageal surgery, current peptic ulcer disease or gastric cancer and previous Helicobacter pylori eradication. Two biopsy specimens were obtained from each of four sites: antrum, body and fundus, respectively. All biopsy specimens were stained with H&E, Alcian-blue and Giemsa. H. pylori infection was determined by histology. The severity of gastritis was graded according to the updated Sydney system. Results: The prevalence rate of Helicobacter pylori infection was 50.0% (21/42) in patients with reflux esophagitis and 64.1% (25/39) in controls (a non-significant difference). The severity of gastritis in each sites was not significantly different between Helicobacter pylori positive patients and Helicobacter pylori positive controls. Conclusions: Helicobacter pylori infection has no role in the pathogenesis of reflux esophagitis.
46 The future of acid suppression therapy trial with rabeprazole: preliminary analysis of acute symptom relief Leonard Jokubaitis, MD, Anita Murthy, PharmD, Ronald Hegedus, BA, Malcolm Robinson, MD*. Oklahoma Foundation for Digestive Research, Oklahoma City, OK, United States.
2424
Abstracts
AJG – Vol. 95, No. 9, 2000
Purpose: The recently completed F.A.S.T. (Future of Acid Suppression Therapy) Trial evaluated the effectiveness of rabeprazole 20 mg tablets administered once daily to over 2,500 patients with erosive esophagitis recently diagnosed by 420 community-based gastroenterologists. This preliminary analysis was performed with those patients whose start date of rabeprazole therapy coincided with the date of baseline symptom registration. Methods: This was an open label trial in patients with erosive GERD (modified Hetzel-Dent Grades 2– 4) endoscopically confirmed within 10 days of study entry. Baseline symptoms were defined as the average severity over the week prior to the first dose of rabeprazole. Symptoms of daytime and nighttime heartburn during the first 7 days of therapy and at Week 4 were assessed via an interactive telephone response system (beginning within 24 –36 hours of enrollment) and were rated on a 4-point Likert scale from 0 (no symptoms) to 3 (severe symptoms). Mean Scores were computed on all available data, while complete relief (score ⫽ 0) was assessed in all patients symptomatic at baseline and satisfactory relief (score ⫽ 0 or 1) was computed for all patients who had moderate or severe symptoms at baseline. Results: A total of 2102 subjects were evaluable for this analysis. Mean age was 52.1, 59% were male and 62% were grade 2 by endoscopy. Symptom responses over the first 7 days of treatment for both daytime and nighttime heartburn are displayed in the table below. Table. Daytime and Nighttime Heartburn Response Parameter Daytime Mean Score Daytime Complete Relief (%) Daytime Satisfactory Relief (%) Nighttime Mean Score Nighttime Complete Relief (%) Nighttime Satisfactory Relief (%)
Base- Day Day Day Day Day Day Day line 1 2 3 4 5 6 7 1.67 0.53 0.41 0.34 0.32 0.30 0.29 0.25 — 63.6 70.7 75.1 76.3 77.9 79.4 81.2 78.4 85.5 88.1 89.1 89.8 90.0 91.2 1.72 0.48 0.31 0.28 0.25 0.23 0.21 0.20 — 69.1 78.1 80.9 82.3 83.3 85.5 85.7 77.6 87.8 89.3 91.2 91.1 92.0 91.7
Conclusions: In this large group of erosive esophagitis patients, rabeprazole 20 mg relieved both daytime and nighttime heartburn, with evidence of fast symptom relief seen with the first dose, with sustained and cumulative therapeutic efficacy throughout the first week of treatment. Research supported by Janssen Pharmaceutica, Titusville, NJ, and Eisai Inc., Teaneck, NJ.
47 Laparoscopic Nissen fundoplication reduces pharmacy costs in GERD Michael Jones, M.D., Richard Wright, M.D., Scott Latimer, M.D., Maria Lopez. Northwestern University, Chicago, IL, University of Louisville, Louisville, KY. In addition to providing symptom relief and preventing complications of GERD, the laparoscopic Nissen fundoplication has been promoted as a cost-saving operation to reduce the use of GI medications. Purpose: To retrospectively analyze the use of GI medications before and after laparoscopic Nissen fundoplication. Methods: From a database of 200,000 covered patient lives in a large managed care plan, all individuals who underwent laparoscopic Nissen fundoplication from 1-1-98 to 6-30-98 were analyzed via paid claims data retrospectively for prescriptions of antisecretory and prokinetic medications. Only members continuously enrolled in the program from 7-1-97 to 12-31-98 were studied. Results: 17 patients (9M, 8F; mean age ⫽ 44 yrs) underwent laparoscopic Nissen fundoplication during the study period. In the 6 months prior to surgery, 17/17 patients received 110 prescriptions with a total cost of $10,245 and an average cost of $99.38/pt/mo. In the 6 months after laparoscopic Nissen fundoplication, only 3/17 patients received a total of ten prescriptions for GI medications at a total cost of $595 and an average cost of $5.85/pt/mo.
Conclusion: In the 6 month period following surgery, laparoscopic Nissen fundoplication was associated with significant reduction in the number of patients requiring medication for GERD, reduced total costs for GI medications and reductions in medication costs for those few patients requiring continuing medical therapy.
Pre-Op Post-Op
% Requiring Meds
# Scripts
Total GI Med Cost
Cost/Pt Receiving GI Meds (Mean ⴞ SE)
17 (100%) 3 (18%)
110 10
$10,245* $ 596**
$603 ⫾ 118 $199 ⫾ 119
* p ⬍ 0.0001 (Chi Square); ** p ⬍ 0.0002 (Paired t test).
48 Assessment of clinical outcomes and patient satisfaction in patients with GERD and dyspepsia after proton pump inhibitor substitution in a VA setting Kalpana R Kalahasthy, Prateek Sharma*, Allan P Weston, Donald Campbell. VA Medical Center, Kansas City, MO, United States. Purpose: PPIs have been used in the VAMCs in the past 9 years. There has been a formulary switch in the VA system from omeprazole(ome) to lansoprazole(lan) (in 1996). The aim was to examine symptom control, side effect profile, patient satisfaction and the percentage of patients who switched back to omeprazole. Methods: 1. A standard questionnaire was provided to all patients on omeprazole and an equal number of randomly selected patients on lansoprazole. Questionnaires were performed by telephone and if unable to contact, by mail. 2. The questionnaire compared adequacy of symptom control, presence of side effects and patient satisfaction with the current PPI therapy. Results: There were 1310 pts on PPIs in the VAMC database. 96 pts (7%) were switched to ome from lan. Omeprazole group: 45 of 96 pts answered the questionnaire. The reasons for switching included inadequate symptom control: 16 pts (36%), side effects 18 pts (40%), and both 9 pts (20%). 25 pts (56%) felt that their symptoms were better controlled on ome. Side effects included diarrhea 20 pts (44%), abdominal pain 6 pts (13%), nausea 4 pts (8%), headache 2 pts (4%), and 1 pt each with anaphylactic reaction, hives, flatus and chest pain. Lansoprazole group: A response was obtained from 47 pts who are currently on lan. Of these 18 pts (38%) were satisfied with either PPI. 18 pts (38%) felt symptom control was better on lan whereas 4 pts (9%) felt that their symptoms were better controlled on ome although they continued taking lan. Side effects on lan included: 3 pts (6%) diarrhea, 2 pts (4%) abdominal pain, 1 pt each with nausea and excessive flatus. Conclusions: 1. 7% of patients switched back to omeprazole at our VAMC during the VA formulary substitution either due to inadequate symptom control or adverse reactions to lansoprazole and a similar percent of patients (9%) continued to take lansoprazole in spite of inadequate symptom control. 2. The majority of patients did well with the formulary switch. 3. Inadequate symptom control and side effects need to be taken into consideration for future formulary substitutions. 49 Comparison of the new PPI esomeprazole, the S-isomer of omeprazole, vs placebo for the treatment of symptomatic GERD (sGERD) Philip O. Katz, MD, FACG, Donald O. Castell, MD, FACG. Graduate Hospital, Philadelphia, PA. Victoria Marino, BSMT, James Whipple, MS, Jeffrey G. Levine, MD. AstraZeneca LP, Wayne, PA. Purpose: To assess the efficacy of esomeprazole (NEXIUM™) vs placebo for the complete resolution of heartburn (HB) in sGERD patients. Methods: Two randomized, double-blind, 4-week, multicenter trials (Study 1 and Study 2) compared once-daily esomeprazole 40 mg (E40) and
toxin (1 ml aliquots) in each quadrant (total 80 –100 units) using 25 gauge Variject sclerotherapy needle (Microvasive, Milford, MA) followed by positioning of 25 mm size 8 cm long TTS anastomotic balloon catheter (Microvasive, MA) and inflating up to specified PSI/Atm for 30 seconds. All patients had LES pressure measurements at the end of procedure and were followed up by scintigraphic esophageal clearence study and/or manometry after 6 months. Results: All 9 patients had successful dilatation and BOTOX injection and tolerated procedure well. The TTS balloon dilatation was simple and easy to perform and no perforations or other complications were noted. The follow-up period ranged from 3–18 months. All nine patients had significant improvement in their swallowing ability and symptom score. LES pressures prior to therapy were in the range of 30 – 60 mmhg and dropped to ⬍25 mmhg in all cases. 4 patients underwent therapy ⬎15 months ago and did not require any additional treatment so far. Conclusions: Our preliminary experience suggests that combination therapy using BOTOX injection and 25 mm TTS balloon dilatation therapy is effective and durable for treatment of achalasia. However a larger study and long term followup will be required to determine if this method is superior to either BOTOX injection or 30 –35 mm pneumatic dilatation alone. 43 Report of a case illustrating the dilemma of primary esophageal pseudodiverticulosis with colonization of candida vs. recurrent esophageal candidiasis leading to pseudodiverticulosis Surya P Irakam, C Kunavarapu, M Hasan, F Marsh, M Cerulli*. Interfaith Medical Center, Brooklyn Hospital Center, Brooklyn, NY, United States. Purpose: Candidal Esophagitis remains the most important and at times most difficult differential diagnostic consideration in patients with diffuse intramural esophageal pseudodiverticulosis. It’s role as primary pathogen remains to be studied. Methods: Here we are reporting an interesting case illustrating the dilemma. Results: A 33 year old B/F with H/O HIV Disease was seen in ER with dysphagia in Nov, 1997 and Endoscopy showed typical whitish plaques lining esophagus and biopsy confirmed candidiasis. She responded symptomatically to fluconazole initially. After a few months her symptoms recurred, she refused repeat endoscopy persistently. As an alternative esophagogram was done, which showed shaggy appearance of mucosa, highly suggestive of candidiasis and she was started on Amphoterecin B for presumed fluconazole resistant candidiasis, but no response was seen. After several visits and admissions, she accepted for EGD in Dec 98, which showed multiple small diverticuli in linear fashion mainly in middle 1/3 and lower 1/3 of esophagus. Smear and histology did not reveal candidiasis. Her symptoms never progressed, in spite of discontinuing Amphoterecin. Conclusions: Our case illustrates the dilemma of which is first, pseudodiverticulosis (leading to colonization of candida) or chronic candidiasis (leading to pseudodiverticuli formation). 44 Technical feasibility of ambulatory pH monitoring for esophagopharyngeal and gastroesophageal acid reflux Abdul Jabbar, MD, Zarina Mohiuddin, Brian Hawkins, MD, Mark Wilson, MD, Debbie Huff, RN, John Wo, MD. University of Louisville, Louisville, KY. Ambulatory pH testing is considered very reliable for distal esophageal reflux (DR), but technical aspects of detecting esophagopharyngeal reflux (EPR) is unclear. Purpose: To compare technical feasibility between pharyngeal and esophageal pH testing. Methods: 101 consecutive 24-hr dual-sensor pH tracings (46 EPR/55 DR) were evaluated. Dual-sensors were placed in the pharynx & proximal
Abstracts
2423
esophagus for EPR and proximal & distal esophagus for DR. Tracings were read randomly with the interpreter blinded to pt’s name, symptoms and type of monitoring. Proximal reflux episode was defined when: 1) nadir has pH ⬍ 4, 2) abrupt drop in pH (onset to nadir in ⬍30 seconds) and 3) pH drop during distal sensor pH ⬍ 4. The following artifacts were defined prospectively; type 1: out of range (pH ⫽ 0 or ⬎9), type 2: pH drift (onset of pH drop to nadir ⬎30 seconds) and type 3: isolated pH drop (proximal sensor pH ⬍ 4 without distal pH ⬍ 4). Overall results were calculated before and after exclusion of artifacts. Results: No significant differences in artifacts were detected between EPR and DR (see table). Conclusions: 1) Type and duration of pH artifacts were similar between EPR and DR pH testing. 2) Changes in total acid exposure after excluding artifacts are minimal. 3) pH testing in the pharynx is as technically feasible as in distal esophagus.
Study duration (median) Total # of artifacts # of type 1 artifacts # of type 2 artifacts # of type 3 artifacts # of artifacts/study* Total time of artifacts/study* # of studies with no artifacts Total % time pH ⬍ 4 before adjustment* Total % time pH ⬍ 4 after adjustment*
EPR pH testing
DR pH testing
22 hrs 55 mins 119 29 (24%) 31 (26%) 61 (50%) 1 (0–17) 3 mins (0–423) 14 (30%) 0.6% (0–28) 0.5% (0–8.5)
22 hrs 43 mins 41 35 (25%) 31 (22%) 75 (53%) 1 (0–15) 2 mins (0–159) 23** (42%) 5.4% (0–34) 5.1% (0–34)
* presented as median (range), ** no difference by chi square test.
45 Does Helicobacter pylori infection have a role in the pathogenesis of reflux esophagitis? Seong Gook Jeon, Yi Kyung Chun. Samsung Cheil Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. Purpose: Whether Helicobacter pylori infection protects against reflux esophagitis is controversial. The aim of the present study is to investigate the role of Helicobacter pylori infection in the pathogenesis of reflux esophagitis. Methods: Forty-two consecutive patients (male:female ⫽ 15:28, mean age: 48 yr) with reflux esophagitis on EGD were studied. Sex and age matched, 39 asymptomatic subjects who underwent EGD for regular physical check-up were used as a control group. Exclusion criteria included the use of antibiotics within 30 days before EGD, prior gastric or esophageal surgery, current peptic ulcer disease or gastric cancer and previous Helicobacter pylori eradication. Two biopsy specimens were obtained from each of four sites: antrum, body and fundus, respectively. All biopsy specimens were stained with H&E, Alcian-blue and Giemsa. H. pylori infection was determined by histology. The severity of gastritis was graded according to the updated Sydney system. Results: The prevalence rate of Helicobacter pylori infection was 50.0% (21/42) in patients with reflux esophagitis and 64.1% (25/39) in controls (a non-significant difference). The severity of gastritis in each sites was not significantly different between Helicobacter pylori positive patients and Helicobacter pylori positive controls. Conclusions: Helicobacter pylori infection has no role in the pathogenesis of reflux esophagitis.
46 The future of acid suppression therapy trial with rabeprazole: preliminary analysis of acute symptom relief Leonard Jokubaitis, MD, Anita Murthy, PharmD, Ronald Hegedus, BA, Malcolm Robinson, MD*. Oklahoma Foundation for Digestive Research, Oklahoma City, OK, United States.
2424
Abstracts
AJG – Vol. 95, No. 9, 2000
Purpose: The recently completed F.A.S.T. (Future of Acid Suppression Therapy) Trial evaluated the effectiveness of rabeprazole 20 mg tablets administered once daily to over 2,500 patients with erosive esophagitis recently diagnosed by 420 community-based gastroenterologists. This preliminary analysis was performed with those patients whose start date of rabeprazole therapy coincided with the date of baseline symptom registration. Methods: This was an open label trial in patients with erosive GERD (modified Hetzel-Dent Grades 2– 4) endoscopically confirmed within 10 days of study entry. Baseline symptoms were defined as the average severity over the week prior to the first dose of rabeprazole. Symptoms of daytime and nighttime heartburn during the first 7 days of therapy and at Week 4 were assessed via an interactive telephone response system (beginning within 24 –36 hours of enrollment) and were rated on a 4-point Likert scale from 0 (no symptoms) to 3 (severe symptoms). Mean Scores were computed on all available data, while complete relief (score ⫽ 0) was assessed in all patients symptomatic at baseline and satisfactory relief (score ⫽ 0 or 1) was computed for all patients who had moderate or severe symptoms at baseline. Results: A total of 2102 subjects were evaluable for this analysis. Mean age was 52.1, 59% were male and 62% were grade 2 by endoscopy. Symptom responses over the first 7 days of treatment for both daytime and nighttime heartburn are displayed in the table below. Table. Daytime and Nighttime Heartburn Response Parameter Daytime Mean Score Daytime Complete Relief (%) Daytime Satisfactory Relief (%) Nighttime Mean Score Nighttime Complete Relief (%) Nighttime Satisfactory Relief (%)
Base- Day Day Day Day Day Day Day line 1 2 3 4 5 6 7 1.67 0.53 0.41 0.34 0.32 0.30 0.29 0.25 — 63.6 70.7 75.1 76.3 77.9 79.4 81.2 78.4 85.5 88.1 89.1 89.8 90.0 91.2 1.72 0.48 0.31 0.28 0.25 0.23 0.21 0.20 — 69.1 78.1 80.9 82.3 83.3 85.5 85.7 77.6 87.8 89.3 91.2 91.1 92.0 91.7
Conclusions: In this large group of erosive esophagitis patients, rabeprazole 20 mg relieved both daytime and nighttime heartburn, with evidence of fast symptom relief seen with the first dose, with sustained and cumulative therapeutic efficacy throughout the first week of treatment. Research supported by Janssen Pharmaceutica, Titusville, NJ, and Eisai Inc., Teaneck, NJ.
47 Laparoscopic Nissen fundoplication reduces pharmacy costs in GERD Michael Jones, M.D., Richard Wright, M.D., Scott Latimer, M.D., Maria Lopez. Northwestern University, Chicago, IL, University of Louisville, Louisville, KY. In addition to providing symptom relief and preventing complications of GERD, the laparoscopic Nissen fundoplication has been promoted as a cost-saving operation to reduce the use of GI medications. Purpose: To retrospectively analyze the use of GI medications before and after laparoscopic Nissen fundoplication. Methods: From a database of 200,000 covered patient lives in a large managed care plan, all individuals who underwent laparoscopic Nissen fundoplication from 1-1-98 to 6-30-98 were analyzed via paid claims data retrospectively for prescriptions of antisecretory and prokinetic medications. Only members continuously enrolled in the program from 7-1-97 to 12-31-98 were studied. Results: 17 patients (9M, 8F; mean age ⫽ 44 yrs) underwent laparoscopic Nissen fundoplication during the study period. In the 6 months prior to surgery, 17/17 patients received 110 prescriptions with a total cost of $10,245 and an average cost of $99.38/pt/mo. In the 6 months after laparoscopic Nissen fundoplication, only 3/17 patients received a total of ten prescriptions for GI medications at a total cost of $595 and an average cost of $5.85/pt/mo.
Conclusion: In the 6 month period following surgery, laparoscopic Nissen fundoplication was associated with significant reduction in the number of patients requiring medication for GERD, reduced total costs for GI medications and reductions in medication costs for those few patients requiring continuing medical therapy.
Pre-Op Post-Op
% Requiring Meds
# Scripts
Total GI Med Cost
Cost/Pt Receiving GI Meds (Mean ⴞ SE)
17 (100%) 3 (18%)
110 10
$10,245* $ 596**
$603 ⫾ 118 $199 ⫾ 119
* p ⬍ 0.0001 (Chi Square); ** p ⬍ 0.0002 (Paired t test).
48 Assessment of clinical outcomes and patient satisfaction in patients with GERD and dyspepsia after proton pump inhibitor substitution in a VA setting Kalpana R Kalahasthy, Prateek Sharma*, Allan P Weston, Donald Campbell. VA Medical Center, Kansas City, MO, United States. Purpose: PPIs have been used in the VAMCs in the past 9 years. There has been a formulary switch in the VA system from omeprazole(ome) to lansoprazole(lan) (in 1996). The aim was to examine symptom control, side effect profile, patient satisfaction and the percentage of patients who switched back to omeprazole. Methods: 1. A standard questionnaire was provided to all patients on omeprazole and an equal number of randomly selected patients on lansoprazole. Questionnaires were performed by telephone and if unable to contact, by mail. 2. The questionnaire compared adequacy of symptom control, presence of side effects and patient satisfaction with the current PPI therapy. Results: There were 1310 pts on PPIs in the VAMC database. 96 pts (7%) were switched to ome from lan. Omeprazole group: 45 of 96 pts answered the questionnaire. The reasons for switching included inadequate symptom control: 16 pts (36%), side effects 18 pts (40%), and both 9 pts (20%). 25 pts (56%) felt that their symptoms were better controlled on ome. Side effects included diarrhea 20 pts (44%), abdominal pain 6 pts (13%), nausea 4 pts (8%), headache 2 pts (4%), and 1 pt each with anaphylactic reaction, hives, flatus and chest pain. Lansoprazole group: A response was obtained from 47 pts who are currently on lan. Of these 18 pts (38%) were satisfied with either PPI. 18 pts (38%) felt symptom control was better on lan whereas 4 pts (9%) felt that their symptoms were better controlled on ome although they continued taking lan. Side effects on lan included: 3 pts (6%) diarrhea, 2 pts (4%) abdominal pain, 1 pt each with nausea and excessive flatus. Conclusions: 1. 7% of patients switched back to omeprazole at our VAMC during the VA formulary substitution either due to inadequate symptom control or adverse reactions to lansoprazole and a similar percent of patients (9%) continued to take lansoprazole in spite of inadequate symptom control. 2. The majority of patients did well with the formulary switch. 3. Inadequate symptom control and side effects need to be taken into consideration for future formulary substitutions. 49 Comparison of the new PPI esomeprazole, the S-isomer of omeprazole, vs placebo for the treatment of symptomatic GERD (sGERD) Philip O. Katz, MD, FACG, Donald O. Castell, MD, FACG. Graduate Hospital, Philadelphia, PA. Victoria Marino, BSMT, James Whipple, MS, Jeffrey G. Levine, MD. AstraZeneca LP, Wayne, PA. Purpose: To assess the efficacy of esomeprazole (NEXIUM™) vs placebo for the complete resolution of heartburn (HB) in sGERD patients. Methods: Two randomized, double-blind, 4-week, multicenter trials (Study 1 and Study 2) compared once-daily esomeprazole 40 mg (E40) and