Kathryn F Flack1, Jay Desai2, Jennifer M Kolb2, Prapti Chatterjee2, Lars C Wallentin3, Michael Ezekowitz4, Salim Yusuf5, Stuart Connolly5, Paul Reilly6, Martina Brueckmann7, John Ilgenfritz8, James Aisenberg2. 1. Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: katie.b.friedman@gmail.com. 2. Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 4. Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania. 5. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. 6. Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut. 7. Boehringer Ingelheim GmbH&CoKG, Ingelheim, Germany; Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany. 8. Ilgenfritz Consulting, LLC, Conshohocken, Pennsylvania.
Abstract
BACKGROUND & AIMS:Gastrointestinal (GI) bleeding in patients receiving anticoagulation agents can be caused by occult malignancies. We investigated the proportions and features of major GI bleeding (MGIB) events related to occult GI cancers in patients receiving anticoagulation therapy. METHODS: We analyzed data from the Randomized Evaluation of Long Term Anticoagulant Therapy study (conducted between December 2005 and March 2009 in 951 clinical centers in 44 countries worldwide), which compared the abilities of dabigatran vs warfarin to prevent stroke and systemic embolism in 18,113 patients with atrial fibrillation. Two blinded gastroenterologists independently reviewed source documents of MGIB events (n = 595) that occurred during the study period. We collected data on MGIB events caused by previously unidentified GI malignancies, and compared characteristics of MGIB events in patients who received dabigatran vs warfarin (primary end point), and in patients with bleeding from cancer, vs patients bleeding from a nonmalignant or unidentified source. RESULTS: Of 546 unique MGIB events, 44 (8.1%) were found to be from GI cancers (34 of 398 MGIB events in dabigatran users and 10 of 148 MGIB events in warfarin users; P = .60). Colorectal cancer accounted for 35 of 44 of all cancers identified. There were more colorectal cancer-associated MGIB events in the dabigatran group (30 of 34) than in the warfarin group (5 of 10) (P = .02), but more gastric cancer-associated MGIB events in the warfarin group (5 of 10) than in the dabigatran group (1 of 34) (P = .001). There were no differences in the short-term outcomes of cancer-related MGIB events in the dabigatran vs the warfarin group, but 75% of all cancer-related MGIB events required at least 1 blood transfusion and the mean hospital stay was 10.1 days. Compared with MGIB events from a nonmalignant or unidentified source, MGIB from cancer occurred sooner (343.0 vs 223.1 d; P = .003), but the bleeding was more likely to be chronic (for >7 d) (27.3% vs 63.6%; P < .001). CONCLUSIONS: In evaluating data from a study of the effects of anticoagulation therapy, we found approximately 1 of every 12 MGIB events to be related to an occult cancer. Approximately two thirds of cancer-related MGIB presents with chronic bleeding, and morbidity, and resource utilization is high.
RCT Entities:
BACKGROUND & AIMS: Gastrointestinal (GI) bleeding in patients receiving anticoagulation agents can be caused by occult malignancies. We investigated the proportions and features of major GI bleeding (MGIB) events related to occult GI cancers in patients receiving anticoagulation therapy. METHODS: We analyzed data from the Randomized Evaluation of Long Term Anticoagulant Therapy study (conducted between December 2005 and March 2009 in 951 clinical centers in 44 countries worldwide), which compared the abilities of dabigatran vs warfarin to prevent stroke and systemic embolism in 18,113 patients with atrial fibrillation. Two blinded gastroenterologists independently reviewed source documents of MGIB events (n = 595) that occurred during the study period. We collected data on MGIB events caused by previously unidentified GI malignancies, and compared characteristics of MGIB events in patients who received dabigatran vs warfarin (primary end point), and in patients with bleeding from cancer, vs patientsbleeding from a nonmalignant or unidentified source. RESULTS: Of 546 unique MGIB events, 44 (8.1%) were found to be from GI cancers (34 of 398 MGIB events in dabigatran users and 10 of 148 MGIB events in warfarin users; P = .60). Colorectal cancer accounted for 35 of 44 of all cancers identified. There were more colorectal cancer-associated MGIB events in the dabigatran group (30 of 34) than in the warfarin group (5 of 10) (P = .02), but more gastric cancer-associated MGIB events in the warfarin group (5 of 10) than in the dabigatran group (1 of 34) (P = .001). There were no differences in the short-term outcomes of cancer-related MGIB events in the dabigatran vs the warfarin group, but 75% of all cancer-related MGIB events required at least 1 blood transfusion and the mean hospital stay was 10.1 days. Compared with MGIB events from a nonmalignant or unidentified source, MGIB from cancer occurred sooner (343.0 vs 223.1 d; P = .003), but the bleeding was more likely to be chronic (for >7 d) (27.3% vs 63.6%; P < .001). CONCLUSIONS: In evaluating data from a study of the effects of anticoagulation therapy, we found approximately 1 of every 12 MGIB events to be related to an occult cancer. Approximately two thirds of cancer-related MGIB presents with chronic bleeding, and morbidity, and resource utilization is high.
Authors: Jennifer M Kolb; Kathryn Friedman Flack; Prapti Chatterjee-Murphy; Jay Desai; Lars C Wallentin; Michael Ezekowitz; Stuart Connolly; Paul Reilly; Martina Brueckmann; John Ilgenfritz; James Aisenberg Journal: Dig Dis Sci Date: 2018-03-27 Impact factor: 3.199
Authors: Anne Gulbech Ording; Mette Søgaard; Flemming Skjøth; Erik Lerkevang Grove; Gregory Y H Lip; Torben Bjerregaard Larsen; Peter Brønnum Nielsen Journal: Cancer Med Date: 2021-06-11 Impact factor: 4.452
Authors: Isabela Bispo Santos da Silva Costa; Fernanda Thereza de Almeida Andrade; Diego Carter; Vinicius B Seleme; Maycon Santos Costa; Carlos M Campos; Ludhmila Abrahão Hajjar Journal: Front Cardiovasc Med Date: 2021-06-09