Background: Intravenous lipid emulsions (ILEs) are a risk factor for parenteral nutrition-associated liver disease (PNALD) in the neonatal population. Current literature supports the use of SMOFlipid (4-oil ILE), a fish oil-containing lipid emulsion, for the reversal of PNALD. However, there is little information about the use of 4-oil ILEs for preventing PNALD. The purpose of this study is to examine the safety of a 4-oil ILE in neonates and its effectiveness in preventing PNALD among neonates compared with Intralipid (a soybean-oil, SO-ILE). Methods: This is an observational, cohort, comparative safety study, conducted in a level III neonatal intensive care unit. Participants include neonates who received a 4-oil ILE in their parenteral nutrition (PN) formula, who were matched with historical data of patients who received an SO-ILE, in a 1:3 fashion (4-oil ILE:SO-ILE). The primary outcome of this study is the presence of PNALD (defined as direct bilirubin > 2 mg/dL) after initiation of PN. Results: A total of 1332 participants (333 4-oil ILE vs 999 SO-ILE) were included in the data analysis, and PNALD was found to occur in 1.8% of patients in the 4-oil ILE group and 3.6% of patients in the SO-ILE group (Relative risk (RR) 0.5; 95% CI, 0.21-1.18). Conclusion: The decrease in the incidence of PNALD among the 4-oil ILE group compared with the SO-ILE group indicates a 4-oil ILE may have a hepatoprotective effect.

Aluminum is a common contaminant in many components of parenteral nutrition, especially calcium and phosphate additives. Although long-term effects have been described in the literature, short-term effects are not well-known. Currently, the Food and Drug Administration recommends maintaining aluminum at <5 mcg/kg/day. This was a single center, retrospective case-control study of 102 neonatal intensive care unit patients. Patients were included if they had a diagnosis of necrotizing enterocolitis, rickets/osteopenia, or seizures and received at least 14 days of parenteral nutrition. Patients were matched 1:1 with control patients by gestational age and birth weight. Mean total aluminum exposure for the 14 days of parenteral nutrition was calculated using manufacturer label information. Differences in mean aluminum exposure between cases and controls, as well as subgroup analysis in those with renal impairment or cholestasis, was conducted. Aluminum exposure in patients meeting inclusion criteria closely mirrored the aluminum exposure of control patients. The difference in aluminum exposure was not found to be statistically significant, except in patients with cholestasis. Although the study found no difference in aluminum exposure in short-term complications with neonates, long-term complications are well established and may warrant the need to monitor and limit neonatal aluminum exposure.

Background Bosentan is indicated in the treatment of pulmonary hypertension. Commonly reported adverse reactions are abnormal liver function (10.9%). Purpose To evaluate the risk of hepatotoxicity associated with bosentan, comparing incidence rates with the literature. Materials and methods Retrospective observational study, including all patients with pulmonary hypertension treated with bosentan between June 2003 and April 2013. Patients with previous liver disease were excluded as well as patients referred to other hospitals. Data collected included age, sex, liver aminotransferases (AST and ALT) before and during treatment and time until liver function changed. Normal levels in men were defined as AST 0–4 U/mL and ALT 0–40 U/mL. In women AST is 0–33 U/mL and ALT is 0–32 U/mL. Results The study described 32 patients treated with bosentan, six of whom were excluded: liver damage had been observed previously in 3 patients and no data in the other 3. The other 26 were 12 men and 14 women with a median age of 65.5 years (18–87 years). Serum transaminase levels were elevated to the upper limit normal (ULN) in 10 patients (38.5%). Measures taken were: dose reduction in 1 patient (3.8%), stop treatment in 6 patients (23.0%) and no change in 3 patients (11.5%). In all of them those increases were reversible on the next liver function monitored. Patients had a mean score, before starting treatment, of AST = 19.3 U/mL and ALT = 15.9 U/mL. Average values during treatment were AST = 34.2 U/mL and ALT = 33.4 U/mL. Mean highest levels in patients with hepatotoxicity were AST = 135.7 U/mL and ALT = 145.6 U/mL. In 7, elevation of transaminases occurred during the first 26 weeks of treatment. The median time of the event was 19 weeks (4–416 weeks). The incidence of abnormal increase in hepatic aminotransaminase levels was 38.5%. Conclusions The study describes a greater incidence of hepatotoxicity associated with bosentan than described in the literature. Treatment of these cases should be adjusted. Presence of bosentan and problems with increasing liver aminotransferases are relatively common and serum concentrations should be monitored during treatment. No conflict of interest.

BackgroundThe administration of an intensive dose of statins after acute myocardial infarction (AMI) has proved to be superior to conventional doses in reducing morbidity and mortality (IA evidence) but application in clinical practice is variable.PurposeTo find out whether intensive statins doses are being used after AMI and the involvement of an emergency clinical pharmacist in this quality measure.Material and methodsThe study was conducted from February to April 2014 in an emergency room with a clinical pharmacist of a tertiary hospital. Patients with AMI were recorded and their discharge reports of hospitalisation and blood tests were reviewed. An Excel sheet with the following items was prepared: Patient sex, age, basal low density lipoproteins (LDL), intensive doses of statins after AMI (YES/NO), pharmaceutical intervention to modify the dose of statins to intensive dose (YES/NO), LDL levels at discharge, type and dose of statin scheduled in the discharge report. The target LDL levels after AMI were lower than 70 mg/dl according to clinical practice guidelines (GPC) of the European society of Cardiology (ESC) 2013.Results32 AMIs were recorded. A previous blood test including LDL levels was available in 22 patients, in 95.5% these exceeded 70 mg/dl. 84.4% of the patients received intensive doses of statins in the emergency room, 40.7% prescribed by the physician and 59.3% prescribed after a recommendation by the clinical pharmacist. At hospital discharge all patients except one were prescribed an statin. No patients were discharged with intensive doses.ConclusionThe use of intensive statins doses in the emergency room is high but It Is necessary to unify criteria at hospital discharge.The pharmaceutical recommendation to use intensive doses of statins after AMI implies an increase in compliance with evidence-based recommendations of the GPC.References and/or AcknowledgementsRev Esp Cardiol 2013;66(1):53.e1–46Circulation 2014;129:1303–09Journal of Geriatric Cardiology 2013;10:355–60No conflict of interest.

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