Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU.

BACKGROUND: Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear. METHODS: In this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization. RESULTS: A total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group. The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days were similar in the two groups. CONCLUSIONS: Among adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621 .).

The mortality after surgery in primary lung cancer: results from the Danish Lung Cancer Registry.

OBJECTIVES: The study has been performed to investigate the mortality within the first year after resection in patients with primary lung cancer, together with associated prognostic factors including gender, age, tumour stage, comorbidity, alcohol abuse, type of surgery and post-surgical complications. METHODS: All patients (n = 3363) from the nationwide Danish Lung Cancer Registry with first resection performed between 1 January 2007 and 31 December 2011 were analysed by Kaplan-Meier techniques and Cox-regression analysis concerning death within the first year after resection. Covariates included gender, age, comorbidity (Charlson comorbidity index), perioperative stage, type of resection, registered complications to surgery and alcohol abuse. RESULTS: The cumulative deaths after 30 days, 90 days, 180 days and 360 days were 72 (2.1%), 154 (4.6%), 239 (7.1%) and 478 (14.2%), respectively. Low stage, female gender, young age, no comorbidity, no postoperative complications, no alcohol abuse and lobectomy as type of resection were favourable for survival. CONCLUSIONS: Our results demonstrate that resection in primary lung cancer impacts mortality far beyond the initial 30 days after resection, which is conventionally considered a time window of relevance for the adverse outcome of surgery. Increased efforts should be made for optimizing the selection of patients suited for resection and for identifying patients at increased risk of death after resection. Furthermore, patients should be monitored more closely and more frequently, in particular those patients with high risk of death after resection.

[Gastrointestinal bleeding after treatment with ticagrelor]. / Gastrointestinal blødning ved behandling med ticagrelor.

Ticagrelor is a reversible inhibitor of platelet-aggregation, and is used instead of clopidogrel in the treatment of acute coronary syndrome (ACS). Ticagrelor has documented better outcomes as shown in the PLATO-study, when compared to clopidogrel. However, more major non-CABG bleedings are observed with ticagrelor. Treatment of ACS with platelet-inhibitors is the standard, but there is no antidote for ticagrelor or clopidogrel, making haemostasis problematic in the case of a major bleeding. The following case describes a 76-year-old woman, who after admission for chronic obstructive pulmonary disease and ACS, was treated with ticagrelor and developed a major gastrointestinal bleeding.