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Esomeprazole provides more effective healing than lansoprazole in GERD patients with erosive esophagitis (EE)
S6
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
16 Esomeprazole is more effective than lansoprazole for treating daily and nocturnal heartburn in GERD patients with erosive esophagitis (EE) Donald O Castell*, Peter J Kahrilas, Joel E Richter, David A Johnson, Nimish B Vakil, Seth Zuckerman, Wendy Skammer and Jeffrey G Levine. 1 Graduate Hospital, Philadelphia, PA, United States; 2Northwestern University Medical School, Chicago, IL, United States ; 3Cleveland Clinic Foundation, Cleveland, OH, United States; 4Eastern VA School of Medicine, Norfolk, VA, United States; 5University of Wisconsin Medical School, Milwaukee, WI, United States; 6AstraZeneca LP, Wayne, PA, United States; 7AstraZeneca LP, Wayne, PA, United States; and 8AstraZeneca LP, Wayne, PA, United States. Purpose: Esomeprazole, the S-isomer of omeprazole, is more effective than omeprazole for healing EE and for symptom resolution in patients with EE. Heartburn, including nighttime awakenings due to this symptom, is a major problem for GERD patients. This evaluation assessed the efficacy of esomeprazole (Eso) compared with lansoprazole (Lan) for treating daily and nocturnal heartburn in GERD patients with EE. Methods: This US multicenter, randomized, double-blind trial included 5241 adult patients (ITT population) with EGD-verified EE (Los Angeles grades A-D) who received once daily Eso 40mg or Lan 30mg for up to 8 weeks. Patients recorded daily and nocturnal heartburn symptoms in a diary. Time to resolution from diary data was analyzed using a log-rank test. Additionally, heartburn severity was recorded at baseline and at week 4 by the investigator and was analyzed by a Cochran-Mantel-Haenszel (CMH) test (stratified by baseline severity of heartburn). Sustained resolution was defined as 7 consecutive days without heartburn. Results: Baseline severity of heartburn was balanced between treatment groups. Time to sustained resolution of daily and nocturnal heartburn was faster with Eso than with Lan, while more patients in the Eso group had achieved heartburn resolution (investigator assessment) at week 4 (table). Both treatments were well tolerated. Conclusions: Esomeprazole is more effective than lansoprazole for treating daily and nocturnal heartburn in GERD patients with EE. Variable
Eso 40
Lan 30
Time to Sustained Heartburn Resolution (Median Days), Diary Assessment Time to Sustained Nocturnal Heartburn Resolution (Median Days), Diary Assessment Percent Heartburn Resolution at Week 4, Investigator Assessment
7**
8
1**
2
62.9*
60.2
** p ⬍ 0.01 vs Lan; * p ⬍ 0.05 vs Lan
17 Esomeprazole provides more effective healing than lansoprazole in GERD patients with erosive esophagitis (EE) Donald O Castell*, Peter J Kahrilas, Joel E Richter, David A Johnson, Nimish B Vakil, Seth Zuckerman, Wendy Skammer and Jeffrey G Levine. 1 Graduate Hospital, Philadelphia, PA, United States; 2Northwestern University Medical School, Chicago, IL, United States; 3Cleveland Clinic Foundation, Cleveland, OH, United States; 4Eastern VA School of Medicine, Norfolk, VA, United States; 5University of Wisconsin Medical School, Milwaukee, WI, United States; 6AstraZeneca LP, Wayne, PA, United States; 7AstraZeneca LP, Wayne, United States; and 8 AstraZeneca LP, Wayne, PA, United States. Purpose: Esomeprazole, the S-isomer of omeprazole, is the first PPI to demonstrate higher EE healing rates than omeprazole. Few trials have assessed the healing of one PPI versus another except for trials against omeprazole. The current study directly compared standard doses of esomeprazole (Eso) and lansoprazole (Lan) for healing of EE. Methods: This US multicenter, randomized, double-blind trial included 5241 adult patients (ITT population) with EGD-verified EE (Los Angeles
grades A-D) who received once daily Eso 40mg or Lan 30mg for up to 8 weeks. The primary endpoint, endoscopic healing at Week 8, was analyzed using a log rank test. Healing of EE was also analyzed using a CochranMantel-Haenszel (CMH) test, stratified by baseline severity of EE. Results: Eso 40mg demonstrated significantly higher healing rates (92.6%; 95% CI, 91.5%–93.6%) than Lan 30mg (88.8%; 95% CI, 87.5%–90.0%) at Week 8 (Life Table Estimates, p ⫽ 0.0001). A significant difference was also observed at Week 4. When baseline severity of EE was considered, patients given Eso had a more consistent treatment response across all grades. The difference in cumulative healing rates between Eso and Lan was more pronounced as baseline severity of EE increased. Both treatments were well tolerated. Conclusions: Esomeprazole is more effective than lansoprazole for the healing of EE and produces consistently high healing rates across all grades of esophagitis.
18 Perioperative dislodgement of a dental prosthesis C. Chang M.D., S. Chokhavatia M.D. Department of Medicine, Mount Sinai Services at Queens Hospital Center and Mount Sinai School of Medicine, New York, New York. Introduction: Foreign body ingestion may be accidental (children and elderly with impaired mental status and/or incoordination) or intentional (attention-seeking psychiatric patients). Perioperative ingestion of a dental prosthesis is rare due to strict adherence to preoperative protocols (dental history and oral examination). Case Report: A 33 year old multiparous Pakistani woman was hospitalized at 40 weeks and 4 days of intrauterine pregnancy for induction of labor. Three hours after admission, signs of cord prolapse were noted. The patient underwent emergent cesarian section under general anesthesia and a macrosomic baby boy was uneventfully delivered. Post operatively, the patient could not communicate with the staff due to a language barrier. In the recovery area, she informed her husband of her missing denture, and he relayed this information to the nursing staff. The patient was still under the effect of general anesthesia but denied any respiratory distress or chest discomfort. X-rays showed the presence of a radioopaque partly metallic object overlying the gastric region. A dental consultant determined that the missing retainer bridge over tooth, #6 was consistent with the x-ray findings. Informed consent was obtained from the husband and endoscopic removal of the retainer bridge from the gastric fundus was successfully accomplished utilizing a polypectomy snare. The retainer bridge consisted of a false tooth and two metallic flanges. Conclusion: The adherence to standard preoperative protocols (dental history and oral examination) ordinarily prevents accidental dislodgment of loose teeth and dental prosthesis. This case highlights the importance of observing standard preoperative protocols even during emergencies.
19 Esophageal motor disorders in patients with non-obstructive dysphagia Chien-Lin Chen, M.D.1 and William C Orr, Ph.D. FACG1*. 1Lynn Health Science Institute, Oklahoma City, OK, United States. Purpose: Dysphagia for solids is typically considered a clinical indication of esophageal obstructions, and dysphagia for both solids and liquids suggests an esophageal motor disorder (EMD). It is unclear how these complaints actually distinguish themselves on the basis of the frequency of esophageal motor abnormalities. Typically manometric evaluations do not include an assessment of responses to solid food ingestion in addition to water swallows. Our previous research has suggested that food ingestion manometry is more effective in identifying the presence of EMD. The aim of this study was to assess the presence of EMD in patients with complaints of solids alone compared to those with complaints of both solids and liquids when evaluated with both water swallows and food ingestion manometry.
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
16 Esomeprazole is more effective than lansoprazole for treating daily and nocturnal heartburn in GERD patients with erosive esophagitis (EE) Donald O Castell*, Peter J Kahrilas, Joel E Richter, David A Johnson, Nimish B Vakil, Seth Zuckerman, Wendy Skammer and Jeffrey G Levine. 1 Graduate Hospital, Philadelphia, PA, United States; 2Northwestern University Medical School, Chicago, IL, United States ; 3Cleveland Clinic Foundation, Cleveland, OH, United States; 4Eastern VA School of Medicine, Norfolk, VA, United States; 5University of Wisconsin Medical School, Milwaukee, WI, United States; 6AstraZeneca LP, Wayne, PA, United States; 7AstraZeneca LP, Wayne, PA, United States; and 8AstraZeneca LP, Wayne, PA, United States. Purpose: Esomeprazole, the S-isomer of omeprazole, is more effective than omeprazole for healing EE and for symptom resolution in patients with EE. Heartburn, including nighttime awakenings due to this symptom, is a major problem for GERD patients. This evaluation assessed the efficacy of esomeprazole (Eso) compared with lansoprazole (Lan) for treating daily and nocturnal heartburn in GERD patients with EE. Methods: This US multicenter, randomized, double-blind trial included 5241 adult patients (ITT population) with EGD-verified EE (Los Angeles grades A-D) who received once daily Eso 40mg or Lan 30mg for up to 8 weeks. Patients recorded daily and nocturnal heartburn symptoms in a diary. Time to resolution from diary data was analyzed using a log-rank test. Additionally, heartburn severity was recorded at baseline and at week 4 by the investigator and was analyzed by a Cochran-Mantel-Haenszel (CMH) test (stratified by baseline severity of heartburn). Sustained resolution was defined as 7 consecutive days without heartburn. Results: Baseline severity of heartburn was balanced between treatment groups. Time to sustained resolution of daily and nocturnal heartburn was faster with Eso than with Lan, while more patients in the Eso group had achieved heartburn resolution (investigator assessment) at week 4 (table). Both treatments were well tolerated. Conclusions: Esomeprazole is more effective than lansoprazole for treating daily and nocturnal heartburn in GERD patients with EE. Variable
Eso 40
Lan 30
Time to Sustained Heartburn Resolution (Median Days), Diary Assessment Time to Sustained Nocturnal Heartburn Resolution (Median Days), Diary Assessment Percent Heartburn Resolution at Week 4, Investigator Assessment
7**
8
1**
2
62.9*
60.2
** p ⬍ 0.01 vs Lan; * p ⬍ 0.05 vs Lan
17 Esomeprazole provides more effective healing than lansoprazole in GERD patients with erosive esophagitis (EE) Donald O Castell*, Peter J Kahrilas, Joel E Richter, David A Johnson, Nimish B Vakil, Seth Zuckerman, Wendy Skammer and Jeffrey G Levine. 1 Graduate Hospital, Philadelphia, PA, United States; 2Northwestern University Medical School, Chicago, IL, United States; 3Cleveland Clinic Foundation, Cleveland, OH, United States; 4Eastern VA School of Medicine, Norfolk, VA, United States; 5University of Wisconsin Medical School, Milwaukee, WI, United States; 6AstraZeneca LP, Wayne, PA, United States; 7AstraZeneca LP, Wayne, United States; and 8 AstraZeneca LP, Wayne, PA, United States. Purpose: Esomeprazole, the S-isomer of omeprazole, is the first PPI to demonstrate higher EE healing rates than omeprazole. Few trials have assessed the healing of one PPI versus another except for trials against omeprazole. The current study directly compared standard doses of esomeprazole (Eso) and lansoprazole (Lan) for healing of EE. Methods: This US multicenter, randomized, double-blind trial included 5241 adult patients (ITT population) with EGD-verified EE (Los Angeles
grades A-D) who received once daily Eso 40mg or Lan 30mg for up to 8 weeks. The primary endpoint, endoscopic healing at Week 8, was analyzed using a log rank test. Healing of EE was also analyzed using a CochranMantel-Haenszel (CMH) test, stratified by baseline severity of EE. Results: Eso 40mg demonstrated significantly higher healing rates (92.6%; 95% CI, 91.5%–93.6%) than Lan 30mg (88.8%; 95% CI, 87.5%–90.0%) at Week 8 (Life Table Estimates, p ⫽ 0.0001). A significant difference was also observed at Week 4. When baseline severity of EE was considered, patients given Eso had a more consistent treatment response across all grades. The difference in cumulative healing rates between Eso and Lan was more pronounced as baseline severity of EE increased. Both treatments were well tolerated. Conclusions: Esomeprazole is more effective than lansoprazole for the healing of EE and produces consistently high healing rates across all grades of esophagitis.
18 Perioperative dislodgement of a dental prosthesis C. Chang M.D., S. Chokhavatia M.D. Department of Medicine, Mount Sinai Services at Queens Hospital Center and Mount Sinai School of Medicine, New York, New York. Introduction: Foreign body ingestion may be accidental (children and elderly with impaired mental status and/or incoordination) or intentional (attention-seeking psychiatric patients). Perioperative ingestion of a dental prosthesis is rare due to strict adherence to preoperative protocols (dental history and oral examination). Case Report: A 33 year old multiparous Pakistani woman was hospitalized at 40 weeks and 4 days of intrauterine pregnancy for induction of labor. Three hours after admission, signs of cord prolapse were noted. The patient underwent emergent cesarian section under general anesthesia and a macrosomic baby boy was uneventfully delivered. Post operatively, the patient could not communicate with the staff due to a language barrier. In the recovery area, she informed her husband of her missing denture, and he relayed this information to the nursing staff. The patient was still under the effect of general anesthesia but denied any respiratory distress or chest discomfort. X-rays showed the presence of a radioopaque partly metallic object overlying the gastric region. A dental consultant determined that the missing retainer bridge over tooth, #6 was consistent with the x-ray findings. Informed consent was obtained from the husband and endoscopic removal of the retainer bridge from the gastric fundus was successfully accomplished utilizing a polypectomy snare. The retainer bridge consisted of a false tooth and two metallic flanges. Conclusion: The adherence to standard preoperative protocols (dental history and oral examination) ordinarily prevents accidental dislodgment of loose teeth and dental prosthesis. This case highlights the importance of observing standard preoperative protocols even during emergencies.
19 Esophageal motor disorders in patients with non-obstructive dysphagia Chien-Lin Chen, M.D.1 and William C Orr, Ph.D. FACG1*. 1Lynn Health Science Institute, Oklahoma City, OK, United States. Purpose: Dysphagia for solids is typically considered a clinical indication of esophageal obstructions, and dysphagia for both solids and liquids suggests an esophageal motor disorder (EMD). It is unclear how these complaints actually distinguish themselves on the basis of the frequency of esophageal motor abnormalities. Typically manometric evaluations do not include an assessment of responses to solid food ingestion in addition to water swallows. Our previous research has suggested that food ingestion manometry is more effective in identifying the presence of EMD. The aim of this study was to assess the presence of EMD in patients with complaints of solids alone compared to those with complaints of both solids and liquids when evaluated with both water swallows and food ingestion manometry.