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
Abstract
Brian C. Jacobson, Byron DeLemos, Yijun Sun, Jim Xiang, John LoCoco, Honglan Li, Stefania Casalini
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
Key concepts: Medicine, Overweight, Heartburn, Internal medicine, Gastroenterology, GERD, Obesity, Surgery