Statistics from Altmetric.com
Pantoprazole for stress ulcer prophylaxis in intensive care
The Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) study, published in the New England Journal of Medicine, evaluated the use of prophylactic pantoprazole in patients at risk of gastrointestinal bleeding (GIB) in ICU.1 Interestingly, despite being one of the most commonly used off-licence drugs in ICU, proton pump inhibitors are not Food and Drug Administration (FDA) approved for stress ulcer prophylaxis. In 33 ICUs across Europe, adult patients felt to be at risk of GIB, which included patients with shock, use of anticoagulant agents, renal replacement therapy, mechanical ventilation, history of liver disease or ongoing coagulopathy, were randomised to receive pantoprazole 40 mg versus placebo for stress ulcer prophylaxis (1640 vs 1642). Primary outcome was death within 90 days after randomisation. Secondary outcomes were clinically important events in the ICU defined as clinically important GIB, new-onset pneumonia, Clostridium difficile infection or acute myocardial ischaemia.
In total, 510 of 1642 patients (31.1%) in the pantoprazole group and 499 of 1640 (30.4%) in the placebo group had died (relative risk, 1.02; 95% CI 0.91 to 1.13; p=0.76). A total of 360 (21.9%) of 1644 patients in the pantoprazole group and 372 (22.6%) of 1647 in the placebo group had one or more clinically important events in the ICU (relative risk, 0.96; 95% CI 0.83 to 1.11) but these were not adjusted for multiple comparisons. The authors concluded that there was limited evidence for prophylactic pantoprazole in patients at risk of GIB in ICU setting.
GIB post-ST elevation myocardial infarction (STEMI)
Outside the ICU, a study published in The American Journal of Cardiology examined the incidence, predictors and outcomes following a GIB in patients with STEMI.2 The study included adults admitted with a STEMI between 2003 and 2016 using data from the US National Inpatient Sample database. Among 1 450 696 weighted STEMI hospitalisations from this database, they found that 32 624 (2.2%) were complicated with GIB. They found that in-hospital mortality was higher in the GIB group (28.2% vs 11.1%, p<0.001) compared with those without a GIB. They reported that the strongest predictors of a GIB in patients with STEMI were older age, previous peptic ulcer disease, pre-existing anaemia, cirrhosis, alcohol use disorder and cardiogenic shock. Undergoing endoscopy was associated with higher survival (89.3% vs 69%, p<0.001), although only 10% of patients with post-STEMI GIB underwent endoscopy and these were obviously high-risk patients. In conclusion, this study found that GIB was an uncommon complication post-STEMI but is associated with significant morbidity, mortality and resource utilisation. Furthermore, despite endoscopy carrying risk post-STEMI, this study suggested that endoscopy following a STEMI for a GIB was associated with better survival.
Population trends in inflammatory bowel disease (IBD) before and after availability of biologics
Approximately, 18 years after the approval of infliximab (IFX) in Canada, a retrospective population-based study examined the impact on hospitalisation rates, intestinal resection and prescription drug costs in patients with IBD in Ontario.3 The study, published in Gut, used publicly available data between July 1995 and March 2012 for adult patients receiving publicly funded IFX, which, they report, accounts for 40% of IBD prescriptions. Data were studied over a 5-year period for ulcerative colitis (UC) and a 10-year period for Crohn’s disease (CD).
The authors used an interrupted time series design to permit comparison of the effects of IFX against predicted trends that would be expected if IFX had not been introduced. The predicted trends (‘the counterfactual’) were derived by extrapolating forwards the trends observed in the 6 years prior to introduction of IFX. The study found that the introduction of IFX had no significant effect in the rate of hospitalisation (OR at the last observation quarter 1.06, 95% CI 0.811 to 1.39) or resection rates (OR 1.10, 95% CI 0.810 to 1.50) in the CD cohort. Furthermore, in the UC cohort, there was no significant decline after the introduction of IFX on colectomy rates (observed vs counterfactual OR 4.17, 95% CI 0.145 to 119). The authors propose the differences in their findings when compared with trial and real-life experience of IFX may be explained by failure to optimise IFX regimes in CD and underuse of IFX in UC during the study period. They caution that this was a retrospective study that examined data prior to current strategies used to optimise biologic efficacy and that those patients eligible for public funding for IFX may be different in important characteristics to those who are not.
Fluticasone inhaler versus budesonide solution for eosinophilic oesophagitis (EoE)
This study, published in Gastroenterology, was the first randomised controlled trial comparing oral viscous budesonide (OVB) with swallowed fluticasone metered dose inhaler (MDI) for initial treatment of newly diagnosed patients with EoE.4 Patients aged 16–80 with a new diagnosis were randomised to receive 8 weeks of budesonide 1 mg twice daily and placebo inhaler, or swallowed fluticasone MDI 880 µg twice daily and placebo solution. The primary outcome was post-treatment peak eosinophil count per high-powered field in the most inflamed of four oesophageal biopsies, and a co-primary outcome was change in dysphagia score. The trial demonstrated no difference in reduction of peak eosinphil counts, and no difference in change in dysphagia score, between the two arms. The authors discuss that this trial did not compare formulations of the same drug as previous studies have done, but the two most commonly used treatments in clinical practice (budesonide OVB vs fluticasone MDI). Given the lack of significant difference in effectiveness, they suggest that practical considerations, rather than clinical ones, can determine which initial treatment is chosen.
Contributors MS and JPS reviewed the literature and prepared the manuscript.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Commissioned; externally peer reviewed.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.