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T1069 A Comparative Study On the Healing Effects of Rebamipide and Omeprazole in H. pylori - Positive Gastric Ulcer After Eradication Therapy; A Randomized Double-Blinded, Multicenter Trial
AGA Abstracts
10 µM ATP caused a further increase in [Ca2+]cyt (∆F340/380 0.228 ± 0.042, p<0.01, n=51). Moreover, murine DMBS stimulated by 10 mM HCl was significantly attenuated by luminal pretreatment with 100 µM amiloride (10.63 ± 2.81 vs. 0.05 ± 0.56 µmol/cm-h, P<0.001, n=4-5). Conclusion: ASICs are functionally expressed in intestinal epithelial cells and may play an important role in the regulation of acid-stimulated DMBS. (Supported by the AGA Student Research Fellowship Award to X. Dong and a grant from the Cystic Fibrosis Foundation to H. Dong)
T1068 Perforated Peptic Ulcers in Israel 1995-2004: Unparallel Decrease in the Rates of Perforated Duodenal and Gastric Ulcers Tiberiu Hershcovici, Ziona Haklai, Ethel-Sherry Gordon, Joseph Zimmerman Introduction: A decrease in the rates of peptic ulcer bleeding has recently been reported (1). Aim: To investigate trends in the rates of peptic ulcer perforations in Israel. Methods: Data were obtained from the National Hospital Discharge Database of the Israeli Ministry of Health, where all hospital admissions in Israel are recorded. We identified all admissions for perforated peptic ulcers in the period January 1,1995 through December 31, 2004 according to ICD9 codes for the diagnoses perforated duodenal (PDU): codes 5321-2; 53256 and perforated gastric ulcer (PGU): codes 5311-2;5315-6. Incidence rates, expressed as number of cases/105 population/year, were adjusted to reflect the age and gender distribution of the Israeli population. Data were presented as three-year moving averages. Z- tests were used to determine statistical significance. Results: Between 1995 and 2004 the rates of hospital admissions for both PDU and PGU decreased significantly (p<0.0005 for each). The rate of PDU decreased in the first 5 years of the study period and remained constant thereafter, while that of PGU remained unchanged in the first 5 years and decreased during the latter part of the decade. The decrease in the incidence of PDU and PGU was equally observed in both genders. Conclusions: A significant decrease in the rates of PDU and PGU was observed during 1995-2004. However the trends differed for the two conditions: PDU decreased in the first half of this period, while the decrease in PGU was evident in its latter part. References: 1: Clin Gastroenterol Hepatol 2006; 4:1459-66.
T1066 Risk of Upper Gastrointestinal Complications (UGIC) in Patients with a Previous History of Peptic Ulcer Sonia Hernandez-Diaz, Luis A. García Rodríguez Background: The incidence of UGIC (i.e., bleeding or perforation) is approximately 1 case per 1,000 person-years in the general population; but, it is more than 5 cases per 1,000 persons per year among subjects with a previous history of peptic ulcer, one of the most important risk factors for UGIC.1 Objectives: To provide estimates of risk of UGIC among patients with a previous history of peptic ulcer. Methods: Population-based cohort study of patients 40-84 years old registered in The Health Improvement Network (THIN) database in the UK between January 1997 and December 2005. Patients with cancer, both uncomplicated and complicated peptic ulcer (PU), oesophageal varices, Mallory-Weiss disease, alcohol abuse, liver disease, or coagulopathies before entering the source population were excluded. Within this source population, we identified patients with first ever episode of uncomplicated PU based on a computerized algorithm during the study period. We reviewed each computerized patient profile and classified patients into definite (49%), possible (26%) and non-cases (25%) of uncomplicated PU. We randomly selected 100 definite and 50 possible cases to conduct a validation study. The general practitioners have confirmed 97% of the definite and 82% of the possible cases so far. We then followed-up all members of this preliminary cohort of PU patients, starting after their first ever diagnosis of PU, to identify patients developing a first ever episode of complicated peptic ulcer based on another computerized algorithm (ie, cases not validated yet). Results: The final source population included 1,055,822 persons and 5,282,383 person years. We identified 5,320 potential cases of uncomplicated PU, for an overall incidence rate of 1.0 per 1,000 persons per year. However, based on the validation study, the estimated incidence rate of uncomplicated PU in our population would be close to 0.75 per 1,000 persons per year. Within this cohort of uncomplicated PU patients, the incidence rate of UGIC was 8.2 per 1,000 persons per year (Of note, the incidence of confirmed UGIC among this high-risk group will be lower after we complete our validation study of UGIC events). Both the incidence of uncomplicated PU in the general population and UGIC in uncomplicated PU patients was slightly higher in men than in women and increased with age. Conclusions: Preliminary findings reinforce the importance of validating computerized diagnoses to study a cohort of uncomplicated PU and the subsequent risk of UGIC in that population using large administrative databases. 1. Hernández-Díaz S, García Rodríguez L. J Clin Epidemiol 2002;55:157-63. T1067 Causes of Uncomplicated Peptic Ulcer. A Report of 274 Patients from a Single Danish Center Bo Sondergaard, Christina Reimer, Peter Bytzer Peptic ulcer disease is usually caused by infection with H. pylori, use of ulcerogenic drugs or by a combination of these factors. Earlier studies have shown that the majority of duodenal ulcers (DU) and at least half of gastric ulcers (GU) are associated with H. pylori infection. However, more recent studies have found a decrease in the prevalence of H. pylori in peptic ulcer patients. Moreover, the proportion of patients with idiopathic peptic ulcer not associated with H. pylori or ulcerogenic drugs may be increasing. Aims & methods: We aimed to examine the prevalence of H. pylori infection and the consumption of ulcerogenic drugs, aspirin (ASA) and NSAIDs in patients with endoscopically verified uncomplicated peptic ulcer. Data was extracted from case forms in patients diagnosed during the 3-yr period 2002-04. Patients were classified as being H. pylori infected if a biopsy-based rapid urease test, a urea breath test or histopathology was positive. Consumption of ASA (any dose), NSAIDs and proton pump inhibitors during the previous 30 days was registered. Results: 274 patients (138 males) with a mean age of 65.4 years (range 12-94 y) were investigated. 160 patients (58 %) had a GU, 91 patients (33%) a DU and 23 patients had combined ulcers. The overall prevalence of H. pylori was 44% (120 patients) - in eight patients H. pylori status could not be determined. In GU patients 44% (70) were H. pylori positive, 54% (86) used ASA and 26% (41) used NSAIDs - 17 patients used both ASA and NSAIDs. In DU patients also 44% (40) were H. pylori positive, 36 % (33) used ASA and 25% (23) used NSAIDs - eight patients used both ASA and NSAIDs. In patients with combined ulcers 43 % (10) were H. pylori infected, 65 % (15) used ASA and 22 % (5) used NSAIDs - four patients used both ASA and NSAIDs. The number of patients who were infected and used ulcerogenic drugs were 37 (GU), 14 (DU) and six (combined ulcer). 11 % (18) of GU patients, 18 % (16) of DU patients and 13 % (3) of patients with combined ulcers were classified as having idiopathic peptic ulcers. Male patients were more likely to be H. pylori positive (OR 1.9; 95% CI 1.1-3.0). Patient age was not correlated with the aetiology of the ulcer. Conclusion: The prevalence of H. pylori in GU and DU patients is similar and lower than previously reported. The proportion of patients with idiopathic peptic ulcer is increasing. Use of ulcerogenic drugs is the major causative factor for peptic ulcer disease in this patient population.
AGA Abstracts
T1069 A Comparative Study On the Healing Effects of Rebamipide and Omeprazole in H. pylori - Positive Gastric Ulcer After Eradication Therapy; A Randomized Double-Blinded, Multicenter Trial Kyung Ho Song, Yong Chan Lee, Jin-Ho Kim, Daiming Fan, Zhi-Zheng Ge, Feng Ji, MinHu Chen, Hyun Chae Jung, Jiang Bo, Sang Woo Lee Background: Unlike duodenal ulcer, Helicobacter pylori (H. pylori) eradication therapy alone may not be sufficient for healing gastric ulcer. Antisecretory drug is principal medicine after the eradication, but may affect H. pylori status. Rebamipide, by stimulating production of prostaglandin and epidermal growth factor, is known to promote gastric ulcer healing in a recent placebo-controlled trial, without affecting H. pylori status. We conducted a randomized, double-blind, multicenter trial to compare the healing effects of rebamipide and omeprazole in H. pylori-positive gastric ulcer after the eradication therapy. Patients & Methods: After completion of 1 week of eradication therapy, a total of 132 patients were enrolled trough screening tests in six Chinese and four Korean institutions after written informed consents. Patients were randomly assigned to take either 20mg of omeprazole or 300mg of rebamipide daily for 7 weeks. The primary endpoint was gastric ulcer healing rate. Healing was defined as complete recovery, S1, and S2 according to the Sakita/Miwa classification. Healing rate was evaluated based on differences in healing rates between the two groups. Results: The one hundred and thirty two patients enrolled in the study were allocated to either the rebamipide group (n=65) or omeprazole group (n=67). There were no significant differences in demographics, ulcer stage/size, and smoking habits between the two groups. Healing rates at 12 weeks were 81.5% (53/65) in rebamipide, and 82.5% (52/63) in omeprazole group, respectively. Gastric ulcer healing rates after the treatment did not show any significant difference in efficacy (absolute difference; -1.0%, 95%CI; -10.7 ~ 8.7, p=0.8827). The H. pylori eradication rates were also not different between the groups (rebamipide 73.1%, omeprazole 72.0%, p = 0.7981), and the ulcer healing rate showed no significant difference regardless of eradication outcomes. Conclusions: Rebamipide is as effective as omeprazole in healing of H. pylori-positive gastric ulcer after the eradication therapy.
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10 µM ATP caused a further increase in [Ca2+]cyt (∆F340/380 0.228 ± 0.042, p<0.01, n=51). Moreover, murine DMBS stimulated by 10 mM HCl was significantly attenuated by luminal pretreatment with 100 µM amiloride (10.63 ± 2.81 vs. 0.05 ± 0.56 µmol/cm-h, P<0.001, n=4-5). Conclusion: ASICs are functionally expressed in intestinal epithelial cells and may play an important role in the regulation of acid-stimulated DMBS. (Supported by the AGA Student Research Fellowship Award to X. Dong and a grant from the Cystic Fibrosis Foundation to H. Dong)
T1068 Perforated Peptic Ulcers in Israel 1995-2004: Unparallel Decrease in the Rates of Perforated Duodenal and Gastric Ulcers Tiberiu Hershcovici, Ziona Haklai, Ethel-Sherry Gordon, Joseph Zimmerman Introduction: A decrease in the rates of peptic ulcer bleeding has recently been reported (1). Aim: To investigate trends in the rates of peptic ulcer perforations in Israel. Methods: Data were obtained from the National Hospital Discharge Database of the Israeli Ministry of Health, where all hospital admissions in Israel are recorded. We identified all admissions for perforated peptic ulcers in the period January 1,1995 through December 31, 2004 according to ICD9 codes for the diagnoses perforated duodenal (PDU): codes 5321-2; 53256 and perforated gastric ulcer (PGU): codes 5311-2;5315-6. Incidence rates, expressed as number of cases/105 population/year, were adjusted to reflect the age and gender distribution of the Israeli population. Data were presented as three-year moving averages. Z- tests were used to determine statistical significance. Results: Between 1995 and 2004 the rates of hospital admissions for both PDU and PGU decreased significantly (p<0.0005 for each). The rate of PDU decreased in the first 5 years of the study period and remained constant thereafter, while that of PGU remained unchanged in the first 5 years and decreased during the latter part of the decade. The decrease in the incidence of PDU and PGU was equally observed in both genders. Conclusions: A significant decrease in the rates of PDU and PGU was observed during 1995-2004. However the trends differed for the two conditions: PDU decreased in the first half of this period, while the decrease in PGU was evident in its latter part. References: 1: Clin Gastroenterol Hepatol 2006; 4:1459-66.
T1066 Risk of Upper Gastrointestinal Complications (UGIC) in Patients with a Previous History of Peptic Ulcer Sonia Hernandez-Diaz, Luis A. García Rodríguez Background: The incidence of UGIC (i.e., bleeding or perforation) is approximately 1 case per 1,000 person-years in the general population; but, it is more than 5 cases per 1,000 persons per year among subjects with a previous history of peptic ulcer, one of the most important risk factors for UGIC.1 Objectives: To provide estimates of risk of UGIC among patients with a previous history of peptic ulcer. Methods: Population-based cohort study of patients 40-84 years old registered in The Health Improvement Network (THIN) database in the UK between January 1997 and December 2005. Patients with cancer, both uncomplicated and complicated peptic ulcer (PU), oesophageal varices, Mallory-Weiss disease, alcohol abuse, liver disease, or coagulopathies before entering the source population were excluded. Within this source population, we identified patients with first ever episode of uncomplicated PU based on a computerized algorithm during the study period. We reviewed each computerized patient profile and classified patients into definite (49%), possible (26%) and non-cases (25%) of uncomplicated PU. We randomly selected 100 definite and 50 possible cases to conduct a validation study. The general practitioners have confirmed 97% of the definite and 82% of the possible cases so far. We then followed-up all members of this preliminary cohort of PU patients, starting after their first ever diagnosis of PU, to identify patients developing a first ever episode of complicated peptic ulcer based on another computerized algorithm (ie, cases not validated yet). Results: The final source population included 1,055,822 persons and 5,282,383 person years. We identified 5,320 potential cases of uncomplicated PU, for an overall incidence rate of 1.0 per 1,000 persons per year. However, based on the validation study, the estimated incidence rate of uncomplicated PU in our population would be close to 0.75 per 1,000 persons per year. Within this cohort of uncomplicated PU patients, the incidence rate of UGIC was 8.2 per 1,000 persons per year (Of note, the incidence of confirmed UGIC among this high-risk group will be lower after we complete our validation study of UGIC events). Both the incidence of uncomplicated PU in the general population and UGIC in uncomplicated PU patients was slightly higher in men than in women and increased with age. Conclusions: Preliminary findings reinforce the importance of validating computerized diagnoses to study a cohort of uncomplicated PU and the subsequent risk of UGIC in that population using large administrative databases. 1. Hernández-Díaz S, García Rodríguez L. J Clin Epidemiol 2002;55:157-63. T1067 Causes of Uncomplicated Peptic Ulcer. A Report of 274 Patients from a Single Danish Center Bo Sondergaard, Christina Reimer, Peter Bytzer Peptic ulcer disease is usually caused by infection with H. pylori, use of ulcerogenic drugs or by a combination of these factors. Earlier studies have shown that the majority of duodenal ulcers (DU) and at least half of gastric ulcers (GU) are associated with H. pylori infection. However, more recent studies have found a decrease in the prevalence of H. pylori in peptic ulcer patients. Moreover, the proportion of patients with idiopathic peptic ulcer not associated with H. pylori or ulcerogenic drugs may be increasing. Aims & methods: We aimed to examine the prevalence of H. pylori infection and the consumption of ulcerogenic drugs, aspirin (ASA) and NSAIDs in patients with endoscopically verified uncomplicated peptic ulcer. Data was extracted from case forms in patients diagnosed during the 3-yr period 2002-04. Patients were classified as being H. pylori infected if a biopsy-based rapid urease test, a urea breath test or histopathology was positive. Consumption of ASA (any dose), NSAIDs and proton pump inhibitors during the previous 30 days was registered. Results: 274 patients (138 males) with a mean age of 65.4 years (range 12-94 y) were investigated. 160 patients (58 %) had a GU, 91 patients (33%) a DU and 23 patients had combined ulcers. The overall prevalence of H. pylori was 44% (120 patients) - in eight patients H. pylori status could not be determined. In GU patients 44% (70) were H. pylori positive, 54% (86) used ASA and 26% (41) used NSAIDs - 17 patients used both ASA and NSAIDs. In DU patients also 44% (40) were H. pylori positive, 36 % (33) used ASA and 25% (23) used NSAIDs - eight patients used both ASA and NSAIDs. In patients with combined ulcers 43 % (10) were H. pylori infected, 65 % (15) used ASA and 22 % (5) used NSAIDs - four patients used both ASA and NSAIDs. The number of patients who were infected and used ulcerogenic drugs were 37 (GU), 14 (DU) and six (combined ulcer). 11 % (18) of GU patients, 18 % (16) of DU patients and 13 % (3) of patients with combined ulcers were classified as having idiopathic peptic ulcers. Male patients were more likely to be H. pylori positive (OR 1.9; 95% CI 1.1-3.0). Patient age was not correlated with the aetiology of the ulcer. Conclusion: The prevalence of H. pylori in GU and DU patients is similar and lower than previously reported. The proportion of patients with idiopathic peptic ulcer is increasing. Use of ulcerogenic drugs is the major causative factor for peptic ulcer disease in this patient population.
AGA Abstracts
T1069 A Comparative Study On the Healing Effects of Rebamipide and Omeprazole in H. pylori - Positive Gastric Ulcer After Eradication Therapy; A Randomized Double-Blinded, Multicenter Trial Kyung Ho Song, Yong Chan Lee, Jin-Ho Kim, Daiming Fan, Zhi-Zheng Ge, Feng Ji, MinHu Chen, Hyun Chae Jung, Jiang Bo, Sang Woo Lee Background: Unlike duodenal ulcer, Helicobacter pylori (H. pylori) eradication therapy alone may not be sufficient for healing gastric ulcer. Antisecretory drug is principal medicine after the eradication, but may affect H. pylori status. Rebamipide, by stimulating production of prostaglandin and epidermal growth factor, is known to promote gastric ulcer healing in a recent placebo-controlled trial, without affecting H. pylori status. We conducted a randomized, double-blind, multicenter trial to compare the healing effects of rebamipide and omeprazole in H. pylori-positive gastric ulcer after the eradication therapy. Patients & Methods: After completion of 1 week of eradication therapy, a total of 132 patients were enrolled trough screening tests in six Chinese and four Korean institutions after written informed consents. Patients were randomly assigned to take either 20mg of omeprazole or 300mg of rebamipide daily for 7 weeks. The primary endpoint was gastric ulcer healing rate. Healing was defined as complete recovery, S1, and S2 according to the Sakita/Miwa classification. Healing rate was evaluated based on differences in healing rates between the two groups. Results: The one hundred and thirty two patients enrolled in the study were allocated to either the rebamipide group (n=65) or omeprazole group (n=67). There were no significant differences in demographics, ulcer stage/size, and smoking habits between the two groups. Healing rates at 12 weeks were 81.5% (53/65) in rebamipide, and 82.5% (52/63) in omeprazole group, respectively. Gastric ulcer healing rates after the treatment did not show any significant difference in efficacy (absolute difference; -1.0%, 95%CI; -10.7 ~ 8.7, p=0.8827). The H. pylori eradication rates were also not different between the groups (rebamipide 73.1%, omeprazole 72.0%, p = 0.7981), and the ulcer healing rate showed no significant difference regardless of eradication outcomes. Conclusions: Rebamipide is as effective as omeprazole in healing of H. pylori-positive gastric ulcer after the eradication therapy.
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