Psychiatric Adverse Events Associated With Infliximab: A Cohort Study From the French Nationwide Discharge Abstract Database.

INTRODUCTION: Infliximab (IFX) was the first anti-tumor necrosis factor (TNFα) antibody to be used in the treatment of severe chronic inflammatory diseases, such as Crohn's disease and rheumatoid arthritis. A number of serious adverse drug reactions are known to be associated with IFX use; they include infections, malignancies, and injection site reactions. Although a few case reports have described potential psychiatric adverse events (including suicide attempts and manic episodes), the latter are barely mentioned in IFX's summary of product characteristics. The objective of the present retrospective study was to detect potential psychiatric adverse events associated with IFX treatment by analyzing a national discharge abstract database. MATERIALS AND METHODS: We performed an historical cohort study by analyzing data from the French national hospital discharge abstract database (PMSI) between 2008 and 2014. All patients admitted with one of the five diseases treated with IFX were included. RESULTS: Of the 325,319 patients included in the study, 7,600 had been treated with IFX. The proportion of hospital admissions for one or more psychiatric events was higher among IFX-exposed patients (750 out of 7,600; 9.87%) than among non-exposed patients (17,456 out of 317,719; 5.49%). After taking account of potential confounders in the cohort as a whole, a semi-parametric Cox regression analysis gave an overall hazard ratio (HR) [95% confidence interval] (CI) of 4.5 [3.95; 5.13] for a hospital admission with a psychiatric adverse event during treatment with IFX. The HR (95%CI) for a depressive disorder was 4.97 (7.35; 6.68). Even higher risks were observed for certain pairs of adverse events and underlying pathologies: psychotic disorders in patients treated for ulcerative colitis (HR = 5.43 [2.01; 14.6]), manic episodes in patients treated for severe psoriasis (HR = 12.6 [4.65; 34.2]), and suicide attempts in patients treated for rheumatoid arthritis (HR = 4.45 [1.11; 17.9]). DISCUSSION: The present retrospective, observational study confirmed that IFX treatment is associated with an elevated risk of psychiatric adverse events. Depending on the disease treated, physicians should be aware of these potential adverse events.

Gastric Bypass But Not Sleeve Gastrectomy Increases Risk of Major Osteoporotic Fracture: French Population-Based Cohort Study.

The objective of this work was to investigate the risk of major osteoporotic fracture (MOF; hip, proximal humerus, wrist and distal forearm, and clinical spine) in bariatric surgery patients versus matched controls. Bariatric surgery is associated with an increase in fracture risk. However, it remains unclear whether the same degree of fracture risk is associated with sleeve gastrectomy, which has recently surpassed gastric bypass. Records from the French National Inpatient database were used from 2008 to 2018. Bariatric surgery patients, aged 40 to 65 years, with BMI ≥40 kg/m2 , hospitalized between January 1, 2010 and December 31, 2014, were matched to one control (1:1) by age, sex, Charlson comorbidity index, year of inclusion, and class of obesity (40 to 49.9 kg/m2 versus ≥50 kg/m2 ). We performed a Cox regression analysis to assess the association between the risk of any MOF and, respectively, (i) bariatric surgery (yes/no) and (ii) type of surgical procedure (gastric bypass, gastric banding, vertical banded gastroplasty, and sleeve gastrectomy) versus no surgery. A total of 81,984 patients were included in the study (40,992 in the bariatric surgery group, and 40,992 matched controls). There were 585 MOFs in the surgical group (2.30 cases per 1000 patient-year [PY]) and 416 MOFs in the matched controls (1.93 cases per 1000 PY). The risk of MOF was significantly higher in the surgical group (hazard ratio [HR] 1.22; 95% CI, 1.08-1.39). We observed an increase in risk of MOF for gastric bypass only (HR 1.70; 95% CI, 1.46-1.98) compared with the matched controls. In patients aged 40 to 65 years, gastric bypass but not sleeve gastrectomy or the other procedures increased risk of major osteoporotic fractures. © 2020 American Society for Bone and Mineral Research.

Can We Define Termination Of Resuscitation Criteria In Out-Of-Hospital Hanging?

OBJECTIVE: Survival rate of cardiac arrest due to hanging (H-CA) victims is low. Hence, this leads to the question of the utility of resuscitation in these patients. The objective was to investigate whether there are predictive criteria for survival with a good neurological outcome or predictive criteria for non-survival or survival with a poor neurological outcome enabling us to define the termination of resuscitation rules in these patients. METHODS: Between July 1, 2011 and January 1, 2016, we included 1,689 out-of-hospital cardiac arrests due to hanging. We compared the characteristics of survivors with a good neurological outcome at day 30 with the others. RESULTS: The study population was mainly composed of males with a median age of 48 [37-60]. The overall survival was 2.1%, among which 48.6% had a good neurological outcome. Survivors benefited more often from immediate basic life support than the rest of the subjects, which was corroborated by the shorter no-flow durations. We did not record any difference in terms of advanced cardiac life support initiation frequency and technique between survivors with a good neurological outcome and the rest. Nevertheless, ACLS duration was longer in survivors with a good neurological outcome than in others. CONCLUSIONS: Basic life support (BLS) was the decisive criterion for 15/17 survivors. However, a detailed analysis showed 2 survivors presenting no BLS before the arrival of mobile medical teams and non-shockable rhythms who survived at day 30 with a good neurological outcome. These results lead us to consider that mobile medical team intervention and ACLS attempt are not futile, and the benefit justifies the cost. Thus, we cannot define any rule for the termination of resuscitation.

Traumatic cardiac arrest is associated with lower survival rate vs. medical cardiac arrest - Results from the French national registry.

INTRODUCTION: The survival from traumatic vs. medical out-of-hospital cardiac arrest (OHCA) are not yet well described. The objective of this study was to compare survival to hospital discharge and 30-day survival of non-matched and matched traumatic and medical OHCA cohorts. MATERIAL & METHODS: National case-control, multicentre study based on the French national cardiac arrest registry. Following descriptive analysis, we compared survival rates of traumatic and medical cardiac arrest patients after propensity score matching. RESULTS: Compared with medical OHCA (n = 40,878) trauma victims (n = 3209) were younger, more likely to be male and away from home at the time and less likely to be resuscitated. At hospital admission and at 30 days their survival odds were lower (OR: respectively 0.456 [0.353;0.558] and 0.240 [0.186;0.329]). After adjustment the survival odds for traumatic OHCA were 2.4 times lower at admission (OR: 0.416 [0.359;0.482]) and 6 times lower at day 30 (OR: 0.168 [0.117;0.241]). CONCLUSIONS: The survival rates for traumatic OHCA were lower than for medical OHCA, with wider difference in matched vs. non-matched cohorts. Although the probability of survival is lower for trauma victims, the efforts are not futile and pre-hospital resuscitation efforts seem worthwhile.

Can we identify termination of resuscitation criteria in cardiac arrest due to drowning: results from the French national out-of-hospital cardiac arrest registry.

RATIONALE, AIMS AND OBJECTIVES: The aim of this study was to describe the cohort of persons having experiences fatal and non-fatal drowning events, registered in the French cardiac arrest registry and to identify termination of resuscitation criteria. METHODS: We performed a prospective multicenter study based on data from French cardiac arrest registry database. All patients with cardiac arrest after drowning (CAD) recorded between July 2011 and November 2014 were included. The population description was carried out by medians [interquartile ranges (IQR)] or frequencies. The characteristics were compared in terms of the primary endpoint (alive vs dead at hospital admission) using chi-square or Fisher's exact and the Mann-Whitney U test. The predictive model was carried out using the multivariate logistic regression. RESULTS: The analysis included 234 CAD. The majority of patients were adults (83.6%) and males (64.5%). Most of the submersions occurred out of home (75.6%). We recorded 66.7% of incidents in fresh water. About a third of CAD was witnessed of which 33.8% had an immediate basic life support. Most of CAD patients received an advanced cardiac life support (87.2%). The median Mobile Medical Team response time was 22 [15-30] minutes. At hospital, 40.6% of patients were alive. Twenty one patients (9.0%) were discharged alive. Among them, 17 had a good neurological outcome. Faster interventions generally resulted in higher survival chances (Mobile Medical Team response time OR: 0.960[0.925; 0.996]; P = 0.0.031; no flow duration OR: 0.535[0.313; 0.913]; P = 0.022) if associated with ventilation (OR: 6.742[2.043; 22.250]; P = 0.002). Age (OR: 0.971[0.955; 0.988]; P = 0.001) and location outside (OR: 0.203[0.064; 0.625]; P = 0.007) are the other criteria of our model. CONCLUSIONS: The model is helpful to highlight explanative variables concerning CAD patients' outcome. The next step is the validation of these five factors by a larger study. Prevention and public training to lifesaving behaviours must be considered as priorities in French public health programmes.