Hsueh-Chien Chiang1, Er-Hsiang Yang1, Huang-Ming Hu2,3, Wei-Ying Chen1,4, Wei-Lun Chang1,5, Chung-Tai Wu1,5, Deng-Chyang Wu2,6, Bor-Shyang Sheu1,5, Hsiu-Chi Cheng7,8,9,10. 1. Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, 138 Sheng Li Rd, Tainan, 704302, Taiwan. 2. Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, 100, Ziyou 1st Rd, Kaohsiung, 807377, Taiwan. 3. Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, 68, Zhonghua 3rd Rd, Kaohsiung, 801735, Taiwan. 4. Department of Public Health, College of Medicine, National Cheng Kung University, 138 Sheng Li Rd, Tainan, 704302, Taiwan. 5. Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, 138 Sheng Li Road, North Dist, Tainan, 704302, Taiwan. 6. School of Medicine, College of Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, 100, Ziyou 1st Rd, Kaohsiung, 807377, Taiwan. 7. Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, 138 Sheng Li Rd, Tainan, 704302, Taiwan. teishuki@mail.ncku.edu.tw. 8. Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, 138 Sheng Li Road, North Dist, Tainan, 704302, Taiwan. teishuki@mail.ncku.edu.tw. 9. Institute of Molecular Medicine, College of Medicine, National Cheng Kung University, 138 Sheng Li Road, North Dist, Tainan, 704302, Taiwan. teishuki@mail.ncku.edu.tw. 10. Department of Internal Medicine, Tainan Hospital, Ministry of Health and Welfare, 125 Jhongshan Road, West Central Dist, Tainan, 700007, Taiwan. teishuki@mail.ncku.edu.tw.
Abstract
BACKGROUND: Patients with Rockall scores ≥6 have an increased risk of long-term peptic ulcer rebleeding. This study was aimed toward investigating whether an extended course of oral esomeprazole up to 1 year decreased ulcer rebleeding in such patients. METHODS: We prospectively enrolled 120 patients with peptic ulcer bleeding and Rockall scores ≥6. After an initial 16-week oral proton pump inhibitor (PPI) treatment, patients were randomized to receive a 36-week course of oral twice-daily esomeprazole 20 mg (Group D, n = 60) or once-daily (Group S, n = 60). Thereafter, they were divided into the PPI-on-demand (n = 32) and PPI-discontinued (n = 77) subgroups. Our previous cohort with Rockall scores ≥6 served as the controls (Group C, n = 135); they received only an initial 8- to 16-week oral PPI. The primary and secondary outcomes were peptic ulcer rebleeding during the first year and the second year-and-thereafter, respectively. RESULTS: For the primary outcome, groups D and S comprised a higher proportion of rebleeding-free than Group C (P = 0.008 and 0.03, log-rank test). The competing-risks regression analysis confirmed that extended PPI use and American Society of Anesthesiologists classification were independent factors contributing to the primary outcome. For the secondary outcome, PPI-on-demand had a borderline higher proportion of rebleeding-free than Group C (P = 0.07, log-rank test); however, only the Rockall score was the independent factor. CONCLUSIONS: An extended 36-week course of oral esomeprazole 20 mg, twice- or once-daily for patients with Rockall scores ≥6 reduced ulcer rebleeding during the first year, but the effect needed to be further validated when PPIs were shifted to on-demand or discontinued thereafter (NCT02456012, 28/05/2015).
BACKGROUND: Patients with Rockall scores ≥6 have an increased risk of long-term peptic ulcer rebleeding. This study was aimed toward investigating whether an extended course of oral esomeprazole up to 1 year decreased ulcer rebleeding in such patients. METHODS: We prospectively enrolled 120 patients with peptic ulcer bleeding and Rockall scores ≥6. After an initial 16-week oral proton pump inhibitor (PPI) treatment, patients were randomized to receive a 36-week course of oral twice-daily esomeprazole 20 mg (Group D, n = 60) or once-daily (Group S, n = 60). Thereafter, they were divided into the PPI-on-demand (n = 32) and PPI-discontinued (n = 77) subgroups. Our previous cohort with Rockall scores ≥6 served as the controls (Group C, n = 135); they received only an initial 8- to 16-week oral PPI. The primary and secondary outcomes were peptic ulcer rebleeding during the first year and the second year-and-thereafter, respectively. RESULTS: For the primary outcome, groups D and S comprised a higher proportion of rebleeding-free than Group C (P = 0.008 and 0.03, log-rank test). The competing-risks regression analysis confirmed that extended PPI use and American Society of Anesthesiologists classification were independent factors contributing to the primary outcome. For the secondary outcome, PPI-on-demand had a borderline higher proportion of rebleeding-free than Group C (P = 0.07, log-rank test); however, only the Rockall score was the independent factor. CONCLUSIONS: An extended 36-week course of oral esomeprazole 20 mg, twice- or once-daily for patients with Rockall scores ≥6 reduced ulcer rebleeding during the first year, but the effect needed to be further validated when PPIs were shifted to on-demand or discontinued thereafter (NCT02456012, 28/05/2015).
Authors: Alan N Barkun; Majid Almadi; Ernst J Kuipers; Loren Laine; Joseph Sung; Frances Tse; Grigorios I Leontiadis; Neena S Abraham; Xavier Calvet; Francis K L Chan; James Douketis; Robert Enns; Ian M Gralnek; Vipul Jairath; Dennis Jensen; James Lau; Gregory Y H Lip; Romaric Loffroy; Fauze Maluf-Filho; Andrew C Meltzer; Nageshwar Reddy; John R Saltzman; John K Marshall; Marc Bardou Journal: Ann Intern Med Date: 2019-10-22 Impact factor: 25.391