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Randomized Controlled Trial
. 2022 Jul 11;62(2):ezac124.
doi: 10.1093/ejcts/ezac124.

Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population: insights from the PEPTIC trial

Sean van Diepen  1   2 , Tim Coulson  3   4   5 , Xiaoming Wang  6 , Dawn Opgenorth  1 , Danny J Zuege  7   8 , Jo Harris  9 , Malik Agyemang  10 , Daniel J Niven  7   10 , Rinaldo Bellomo  4   5   11   12 , Stephen E Wright  13 , Paul J Young  4   5   14   15 , Sean M Bagshaw  1   8 ; PEPTIC study investigators and the ANZICS Clinical Trials Group
Affiliations
Randomized Controlled Trial

Efficacy and safety of proton pump inhibitors versus histamine-2 receptor blockers in the cardiac surgical population: insights from the PEPTIC trial

Sean van Diepen et al. Eur J Cardiothorac Surg. .

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.

Keywords: Clostridium difficile infections; Cardiac surgical intensive care unit; Gastrointestinal bleeding; Stress ulcer prophylaxis; Ventilator-associated conditions.

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Figures

Figure 1:
Figure 1:
No difference was observed in the incidence of ventilatory-associated conditions, Clostridium difficile infection, clinically important upper gastrointestinal bleeding or in-hospital mortality.
None
See this image and copyright information in PMC

Comment in

References

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