Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population: insights from the PEPTIC trial. van Diepen, S., Coulson, T., Wang, X., Opgenorth, D., Zuege, D. J., Harris, J., Agyemang, M., Niven, D. J., Bellomo, R., Wright, S. E., Young, P. J., Bagshaw, S. M., PEPTIC study investigators, & Group, t. A. C. T. European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery, 62(2):ezac124, July, 2022. doi abstract bibtex OBJECTIVES: The comparative effectiveness and safety of proton pump inhibitors (PPIs) versus histamine-2 receptor blockers for stress ulcer prophylaxis in the cardiac surgical intensive care unit population is uncertain. Although the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) trial reported a higher risk of mortality in the PPI arm with no difference in gastrointestinal bleeding, detailed information on surgical variables and clinically relevant surgical subgroups was not available. METHODS: The analysis included all Canadian cardiac surgery patients enrolled in the PEPTIC trial. Data were electronically linked using unique patient identifiers to a clinical information system. Outcomes of interest included in-hospital mortality, gastrointestinal bleeding, Clostridium difficile infections, ventilator-associated conditions and length of stay. RESULTS: We studied 823 (50.6%) randomized to PPIs and 805 (49.4%) to histamine-2-receptor blockers. In the intention-to-treat analysis, there were no differences in hospital mortality [PPI: 4.3% vs histamine-2 receptor blockers: 4.8%, adjusted odds ratio (aOR) 0.97, 95% confidence interval (CI) 0.55-1.70], gastrointestinal bleeding (3.9% vs 4.8%, aOR 1.09, 95% CI 0.66-1.81), C. difficile infections (0.9% vs 0.1%, aOR 0.18, 95% CI 0.02-1.59), ventilator-associated conditions (1.6% vs 1.7%, aOR 0.92, 95% CI 0.85-1.00) or median length of stay (9.2 vs 9.8 days, adjusted risk ratio 1.06, 85% CI 0.99-1.13). No significant treatment differences were observed among subgroups of interest or per-protocol populations. CONCLUSIONS: In a secondary analysis of cardiac surgery patients enrolled in the PEPTIC trial in Canada, no differences in effectiveness or safety were observed between use of PPIs and histamine-2 receptor blockers for stress ulcer prophylaxis. CLINICAL TRIAL REGISTRATION NUMBER: anzctr.org.au identifier: ACTRN12616000481471.
@article{van_diepen_efficacy_2022,
title = {Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population: insights from the {PEPTIC} trial},
volume = {62},
issn = {1873-734X},
shorttitle = {Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population},
doi = {10.1093/ejcts/ezac124},
abstract = {OBJECTIVES: The comparative effectiveness and safety of proton pump inhibitors (PPIs) versus histamine-2 receptor blockers for stress ulcer prophylaxis in the cardiac surgical intensive care unit population is uncertain. Although the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) trial reported a higher risk of mortality in the PPI arm with no difference in gastrointestinal bleeding, detailed information on surgical variables and clinically relevant surgical subgroups was not available.
METHODS: The analysis included all Canadian cardiac surgery patients enrolled in the PEPTIC trial. Data were electronically linked using unique patient identifiers to a clinical information system. Outcomes of interest included in-hospital mortality, gastrointestinal bleeding, Clostridium difficile infections, ventilator-associated conditions and length of stay.
RESULTS: We studied 823 (50.6\%) randomized to PPIs and 805 (49.4\%) to histamine-2-receptor blockers. In the intention-to-treat analysis, there were no differences in hospital mortality [PPI: 4.3\% vs histamine-2 receptor blockers: 4.8\%, adjusted odds ratio (aOR) 0.97, 95\% confidence interval (CI) 0.55-1.70], gastrointestinal bleeding (3.9\% vs 4.8\%, aOR 1.09, 95\% CI 0.66-1.81), C. difficile infections (0.9\% vs 0.1\%, aOR 0.18, 95\% CI 0.02-1.59), ventilator-associated conditions (1.6\% vs 1.7\%, aOR 0.92, 95\% CI 0.85-1.00) or median length of stay (9.2 vs 9.8 days, adjusted risk ratio 1.06, 85\% CI 0.99-1.13). No significant treatment differences were observed among subgroups of interest or per-protocol populations.
CONCLUSIONS: In a secondary analysis of cardiac surgery patients enrolled in the PEPTIC trial in Canada, no differences in effectiveness or safety were observed between use of PPIs and histamine-2 receptor blockers for stress ulcer prophylaxis.
CLINICAL TRIAL REGISTRATION NUMBER: anzctr.org.au identifier: ACTRN12616000481471.},
language = {eng},
number = {2},
journal = {European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery},
author = {van Diepen, Sean and Coulson, Tim and Wang, Xiaoming and Opgenorth, Dawn and Zuege, Danny J. and Harris, Jo and Agyemang, Malik and Niven, Daniel J. and Bellomo, Rinaldo and Wright, Stephen E. and Young, Paul J. and Bagshaw, Sean M. and {PEPTIC study investigators and the ANZICS Clinical Trials Group}},
month = jul,
year = {2022},
pmid = {35213716},
pmcid = {PMC9334785},
keywords = {Canada, Cardiac Surgical Procedures, Cardiac surgical intensive care unit, Clostridioides difficile, Clostridium difficile infections, Gastrointestinal Hemorrhage, Gastrointestinal bleeding, Histamine, Histamine H2 Antagonists, Humans, Peptic Ulcer, Proton Pump Inhibitors, Stomach Ulcer, Stress ulcer prophylaxis, Ulcer, Ventilator-associated conditions},
pages = {ezac124},
}
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{"_id":"ThCLapoyvvG5YtpDE","bibbaseid":"vandiepen-coulson-wang-opgenorth-zuege-harris-agyemang-niven-etal-efficacyandsafetyofprotonpumpinhibitorsversushistamine2receptorblockersinthecardiacsurgicalpopulationinsightsfromthepeptictrial-2022","author_short":["van Diepen, S.","Coulson, T.","Wang, X.","Opgenorth, D.","Zuege, D. J.","Harris, J.","Agyemang, M.","Niven, D. J.","Bellomo, R.","Wright, S. E.","Young, P. J.","Bagshaw, S. M.","PEPTIC study investigators","Group, t. A. C. T."],"bibdata":{"bibtype":"article","type":"article","title":"Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population: insights from the PEPTIC trial","volume":"62","issn":"1873-734X","shorttitle":"Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population","doi":"10.1093/ejcts/ezac124","abstract":"OBJECTIVES: The comparative effectiveness and safety of proton pump inhibitors (PPIs) versus histamine-2 receptor blockers for stress ulcer prophylaxis in the cardiac surgical intensive care unit population is uncertain. Although the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) trial reported a higher risk of mortality in the PPI arm with no difference in gastrointestinal bleeding, detailed information on surgical variables and clinically relevant surgical subgroups was not available. METHODS: The analysis included all Canadian cardiac surgery patients enrolled in the PEPTIC trial. Data were electronically linked using unique patient identifiers to a clinical information system. Outcomes of interest included in-hospital mortality, gastrointestinal bleeding, Clostridium difficile infections, ventilator-associated conditions and length of stay. RESULTS: We studied 823 (50.6%) randomized to PPIs and 805 (49.4%) to histamine-2-receptor blockers. In the intention-to-treat analysis, there were no differences in hospital mortality [PPI: 4.3% vs histamine-2 receptor blockers: 4.8%, adjusted odds ratio (aOR) 0.97, 95% confidence interval (CI) 0.55-1.70], gastrointestinal bleeding (3.9% vs 4.8%, aOR 1.09, 95% CI 0.66-1.81), C. difficile infections (0.9% vs 0.1%, aOR 0.18, 95% CI 0.02-1.59), ventilator-associated conditions (1.6% vs 1.7%, aOR 0.92, 95% CI 0.85-1.00) or median length of stay (9.2 vs 9.8 days, adjusted risk ratio 1.06, 85% CI 0.99-1.13). No significant treatment differences were observed among subgroups of interest or per-protocol populations. CONCLUSIONS: In a secondary analysis of cardiac surgery patients enrolled in the PEPTIC trial in Canada, no differences in effectiveness or safety were observed between use of PPIs and histamine-2 receptor blockers for stress ulcer prophylaxis. CLINICAL TRIAL REGISTRATION NUMBER: anzctr.org.au identifier: ACTRN12616000481471.","language":"eng","number":"2","journal":"European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery","author":[{"propositions":["van"],"lastnames":["Diepen"],"firstnames":["Sean"],"suffixes":[]},{"propositions":[],"lastnames":["Coulson"],"firstnames":["Tim"],"suffixes":[]},{"propositions":[],"lastnames":["Wang"],"firstnames":["Xiaoming"],"suffixes":[]},{"propositions":[],"lastnames":["Opgenorth"],"firstnames":["Dawn"],"suffixes":[]},{"propositions":[],"lastnames":["Zuege"],"firstnames":["Danny","J."],"suffixes":[]},{"propositions":[],"lastnames":["Harris"],"firstnames":["Jo"],"suffixes":[]},{"propositions":[],"lastnames":["Agyemang"],"firstnames":["Malik"],"suffixes":[]},{"propositions":[],"lastnames":["Niven"],"firstnames":["Daniel","J."],"suffixes":[]},{"propositions":[],"lastnames":["Bellomo"],"firstnames":["Rinaldo"],"suffixes":[]},{"propositions":[],"lastnames":["Wright"],"firstnames":["Stephen","E."],"suffixes":[]},{"propositions":[],"lastnames":["Young"],"firstnames":["Paul","J."],"suffixes":[]},{"propositions":[],"lastnames":["Bagshaw"],"firstnames":["Sean","M."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["PEPTIC study investigators"],"suffixes":[]},{"firstnames":["the","ANZICS","Clinical","Trials"],"propositions":[],"lastnames":["Group"],"suffixes":[]}],"month":"July","year":"2022","pmid":"35213716","pmcid":"PMC9334785","keywords":"Canada, Cardiac Surgical Procedures, Cardiac surgical intensive care unit, Clostridioides difficile, Clostridium difficile infections, Gastrointestinal Hemorrhage, Gastrointestinal bleeding, Histamine, Histamine H2 Antagonists, Humans, Peptic Ulcer, Proton Pump Inhibitors, Stomach Ulcer, Stress ulcer prophylaxis, Ulcer, Ventilator-associated conditions","pages":"ezac124","bibtex":"@article{van_diepen_efficacy_2022,\n\ttitle = {Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population: insights from the {PEPTIC} trial},\n\tvolume = {62},\n\tissn = {1873-734X},\n\tshorttitle = {Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population},\n\tdoi = {10.1093/ejcts/ezac124},\n\tabstract = {OBJECTIVES: The comparative effectiveness and safety of proton pump inhibitors (PPIs) versus histamine-2 receptor blockers for stress ulcer prophylaxis in the cardiac surgical intensive care unit population is uncertain. Although the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) trial reported a higher risk of mortality in the PPI arm with no difference in gastrointestinal bleeding, detailed information on surgical variables and clinically relevant surgical subgroups was not available.\nMETHODS: The analysis included all Canadian cardiac surgery patients enrolled in the PEPTIC trial. Data were electronically linked using unique patient identifiers to a clinical information system. Outcomes of interest included in-hospital mortality, gastrointestinal bleeding, Clostridium difficile infections, ventilator-associated conditions and length of stay.\nRESULTS: We studied 823 (50.6\\%) randomized to PPIs and 805 (49.4\\%) to histamine-2-receptor blockers. In the intention-to-treat analysis, there were no differences in hospital mortality [PPI: 4.3\\% vs histamine-2 receptor blockers: 4.8\\%, adjusted odds ratio (aOR) 0.97, 95\\% confidence interval (CI) 0.55-1.70], gastrointestinal bleeding (3.9\\% vs 4.8\\%, aOR 1.09, 95\\% CI 0.66-1.81), C. difficile infections (0.9\\% vs 0.1\\%, aOR 0.18, 95\\% CI 0.02-1.59), ventilator-associated conditions (1.6\\% vs 1.7\\%, aOR 0.92, 95\\% CI 0.85-1.00) or median length of stay (9.2 vs 9.8 days, adjusted risk ratio 1.06, 85\\% CI 0.99-1.13). No significant treatment differences were observed among subgroups of interest or per-protocol populations.\nCONCLUSIONS: In a secondary analysis of cardiac surgery patients enrolled in the PEPTIC trial in Canada, no differences in effectiveness or safety were observed between use of PPIs and histamine-2 receptor blockers for stress ulcer prophylaxis.\nCLINICAL TRIAL REGISTRATION NUMBER: anzctr.org.au identifier: ACTRN12616000481471.},\n\tlanguage = {eng},\n\tnumber = {2},\n\tjournal = {European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery},\n\tauthor = {van Diepen, Sean and Coulson, Tim and Wang, Xiaoming and Opgenorth, Dawn and Zuege, Danny J. and Harris, Jo and Agyemang, Malik and Niven, Daniel J. and Bellomo, Rinaldo and Wright, Stephen E. and Young, Paul J. and Bagshaw, Sean M. and {PEPTIC study investigators and the ANZICS Clinical Trials Group}},\n\tmonth = jul,\n\tyear = {2022},\n\tpmid = {35213716},\n\tpmcid = {PMC9334785},\n\tkeywords = {Canada, Cardiac Surgical Procedures, Cardiac surgical intensive care unit, Clostridioides difficile, Clostridium difficile infections, Gastrointestinal Hemorrhage, Gastrointestinal bleeding, Histamine, Histamine H2 Antagonists, Humans, Peptic Ulcer, Proton Pump Inhibitors, Stomach Ulcer, Stress ulcer prophylaxis, Ulcer, Ventilator-associated conditions},\n\tpages = {ezac124},\n}\n\n","author_short":["van Diepen, S.","Coulson, T.","Wang, X.","Opgenorth, D.","Zuege, D. 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