2007The American Journal of GastroenterologyRequires access

PPI Efficacy in Overweight/Obese Patients with Erosive GERD: Rabeprazole (RAB) 20 mg vs Omeprazole (OME) 20 mg

Brian C. Jacobson, Byron DeLemos, Yijun Sun, Jim Xiang, John LoCoco, Honglan Li, Stefania Casalini

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Abstract

Purpose: Obesity is increasing worldwide and elevated BMI is associated with erosive esophagitis (EE). Limited data exist on the efficacy of PPIs among overweight/obese patients. This analysis assessed the efficacy of RAB vs OME in normal weight ( < 25 kg/m2) and overweight/obese (≥25 kg/m2) subjects. Methods: Post hoc analysis by BMI of a multicenter, double-blind, parallel group, randomized trial of RAB 20 mg or OME 20 mg once daily for 4 to 8 weeks (Pace Dig Liver Dis. 2005). Patients (N = 560) had endoscopic evidence of Savary–Miller grade I–III EE, moderate to very severe reflux symptoms, and heartburn for ≥3 days during each of the 2 wks before enrollment. Patients recorded daily symptom severity. Endoscopy was performed at Wk 4 and Wk 8 if not healed at Wk 4. Treatment efficacy by BMI was analyzed using log-rank and Cochran-Mantel-Haenszel tests. Results: Percentage of EE healing (primary endpoint) did not differ between treatment groups within each BMI category or by BMI category within treatment groups. In the overweight/obese group, statistically significant differences favoring RAB were seen in time to 1st day of satisfactory heartburn relief;% complete heartburn relief in each of the first 3 and 7 days of treatment; and% satisfactory heartburn relief in the first 3 days (all P < .05). Numerical trends favoring RAB in both BMI groups were also observed in other secondary endpoints analyzed. Conclusion: EE healing did not differ with RAB 20 mg and OME 20 mg in either BMI group. In overweight/obese patients, RAB may be more effective than OME in heartburn relief in the first week. Sponsored by Eisai Inc; Ortho-McNeil Janssen Scientific Affairs, LLC; Janssen-Cilag.TableTable

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Purpose: Obesity is increasing worldwide and elevated BMI is associated with erosive esophagitis (EE). Limited data exist on the efficacy of PPIs among overweight/obese patients. This analysis assessed the efficacy of RAB vs OME in normal weight ( < 25 kg/m2) and overweight/obese (≥25 kg/m2) subjects. Methods: Post hoc analysis by BMI of a multicenter, double-blind, parallel group, randomized trial of RAB 20 mg or OME 20 mg once daily for 4 to 8 weeks (Pace Dig Liver Dis. 2005). Patients (N = 560) had endoscopic evidence of Savary–Miller grade I–III EE, moderate to very severe reflux symptoms, and heartburn for ≥3 days during each of the 2 wks before enrollment. Patients recorded daily symptom severity. Endoscopy was performed at Wk 4 and Wk 8 if not healed at Wk 4. Treatment efficacy by BMI was analyzed using log-rank and Cochran-Mantel-Haenszel tests. Results: Percentage of EE healing (primary endpoint) did not differ between treatment groups within each BMI category or by BMI category within treatment groups. In the overweight/obese group, statistically significant differences favoring RAB were seen in time to 1st day of satisfactory heartburn relief;% complete heartburn relief in each of the first 3 and 7 days of treatment; and% satisfactory heartburn relief in the first 3 days (all P < .05). Numerical trends favoring RAB in both BMI groups were also observed in other secondary endpoints analyzed. Conclusion: EE healing did not differ with RAB 20 mg and OME 20 mg in either BMI group. In overweight/obese patients, RAB may be more effective than OME in heartburn relief in the first week. Sponsored by Eisai Inc; Ortho-McNeil Janssen Scientific Affairs, LLC; Janssen-Cilag.TableTable

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Available abstract

Purpose: Obesity is increasing worldwide and elevated BMI is associated with erosive esophagitis (EE). Limited data exist on the efficacy of PPIs among overweight/obese patients. This analysis assessed the efficacy of RAB vs OME in normal weight ( < 25 kg/m2) and overweight/obese (≥25 kg/m2) subjects. Methods: Post hoc analysis by BMI of a multicenter, double-blind, parallel group, randomized trial of RAB 20 mg or OME 20 mg once daily for 4 to 8 weeks (Pace Dig Liver Dis. 2005). Patients (N = 560) had endoscopic evidence of Savary–Miller grade I–III EE, moderate to very severe reflux symptoms, and heartburn for ≥3 days during each of the 2 wks before enrollment. Patients recorded daily symptom severity. Endoscopy was performed at Wk 4 and Wk 8 if not healed at Wk 4. Treatment efficacy by BMI was analyzed using log-rank and Cochran-Mantel-Haenszel tests. Results: Percentage of EE healing (primary endpoint) did not differ between treatment groups within each BMI category or by BMI category within treatment groups. In the overweight/obese group, statistically significant differences favoring RAB were seen in time to 1st day of satisfactory heartburn relief;% complete heartburn relief in each of the first 3 and 7 days of treatment; and% satisfactory heartburn relief in the first 3 days (all P < .05). Numerical trends favoring RAB in both BMI groups were also observed in other secondary endpoints analyzed. Conclusion: EE healing did not differ with RAB 20 mg and OME 20 mg in either BMI group. In overweight/obese patients, RAB may be more effective than OME in heartburn relief in the first week. Sponsored by Eisai Inc; Ortho-McNeil Janssen Scientific Affairs, LLC; Janssen-Cilag.TableTable

Key concepts: Medicine, Overweight, Heartburn, Internal medicine, Gastroenterology, GERD, Obesity, Surgery

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