Outcomes of peptic ulcer bleeding following treatment with proton pump inhibitors in routine clinical practice: 935 patients with high- or low-risk stigmata

Abstract

Objective. To assess rates of further bleeding, surgery and mortality in patients hospitalized owing to peptic ulcer bleeding. Materials and methods. Consecutive patients hospitalized for peptic ulcer bleeding and treated with a proton pump inhibitor (PPI) (esomeprazole or pantoprazole) were identified retrospectively in 12 centers in Spain. Patients were included if they had high-risk stigmata (Forrest class Ia–IIb, underwent therapeutic endoscopy and received intravenous PPI ≥120 mg/day for ≥24 h) or low-risk stigmata (Forrest class IIc–III, underwent no therapeutic endoscopy and received intravenous or oral PPI [any dose]). Results. Of 935 identified patients, 58.3% had high-risk stigmata and 41.7% had low-risk stigmata. After endoscopy, 88.3% of high-risk patients and 22.1% of low-risk patients received intravenous PPI therapy at doses of at least 160 mg/day. Further bleeding within 72 h occurred in 9.4% and 2.1% of high- and low-risk patients, respectively (p < 0.001). Surgery to stop bleeding was required within 30 days in 3.5% and 0.8% of high- and low-risk patients, respectively (p = 0.007). Mortality at 30 days was similar in both groups (3.3% in high-risk and 2.3% in low-risk patients). Conclusion. Among patients hospitalized owing to peptic ulcer bleeding and treated with PPIs, patients with high-risk stigmata have a higher risk of further bleeding and surgery, but not of death, than those with low-risk stigmata.

Key Words::

• peptic ulcer hemorrhage
• pharmacoepidemiology
• proton pump inhibitors
• retrospective study

Acknowledgments

We acknowledge and thank Dr Enrique Quintero, Dr Senador Moran, Dr Manuel López Artimez, Dr Rosa Maria Gómez Espín, Dr Teresa Martínez Giménez, Dr Manuel Domínguez, Dr Maria Badía, Dr Enrique-Pérez-Cuadrado, Dr Katalin Aspuru, Pilar Sebastián and Saga Johansson for their help with the study in routine clinical practice. This study was funded by AstraZeneca R&D, Mölndal, Sweden. Writing support was provided by Susan Bromley and Dr Rowan Pearce of Oxford PharmaGenesis™ Ltd and funded by AstraZeneca R&D, Mölndal, Sweden.

Declaration of interest: Angel Lanas has received grant/research support from Pfizer Inc. and AstraZeneca, fees for participating in advisory committees or review panels for Pfizer Inc., Bayer and Nicox, and fees for speaking or teaching from AstraZeneca. Luis A García Rodríguez has received grant/research support from AstraZeneca and Bayer Schering Pharma. Xavier Calvet has received grant/research support from Oxoid Ltd and Janssen-Cilag, consultancy fees from Abbott Laboratories and Almirall Prodesfarma, fees for participating in advisory committees or review panels from AstraZeneca and Schering-Plough Corp., and fees for speaking or teaching from AstraZeneca, Schering-Plough Corp., Abbott Laboratories and Almirall Prodesfarma. Faust Feu has received consultancy fees and speaker fees from AstraZeneca. Julio Ponce has received grant/research support and consulting fees from AstraZeneca. Mónica Polo-Tomas, Patricia Carrera, Santiago García, María Teresa Arroyo Villarino, Angeles Perez-Aisa, Luis Bujanda and José L Calleja have no conflicts of interest to declare.