European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Oct 2016
Effect of prehospital epinephrine on out-of-hospital cardiac arrest: a report from the national out-of-hospital cardiac arrest data registry in Japan, 2011-2012.
The effect of prehospital epinephrine on neurological outcome in out-of-hospital cardiac arrest (OHCA) is still controversial. We sought to determine whether prehospital epinephrine administration was associated with improved outcomes in adult OHCA. ⋯ Among adult OHCA patients, prehospital epinephrine was associated with a decreased chance of neurologically favorable survival. Situations in which prehospital epinephrine is effective may be extremely limited.
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Eur. J. Clin. Pharmacol. · Oct 2016
Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both implemented procedures in order to shorten review time for marketing authorizations with potential therapeutic added value, called priority review and accelerated assessment procedure, respectively. The aim of this study is to compare the new molecular entities (NME) assessed in shorter review time by both agencies and to investigate whether granting a shorter review time status subsequently predicts its therapeutic value attributed by a health technology assessment agency, the French Haute Autorité de Santé (HAS). ⋯ The EMA was restrictive to grant a shorten review time status for products with therapeutic interest during the study period.
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Eur. J. Clin. Pharmacol. · Sep 2016
Observational StudyThe effectiveness of i.v. cefuroxime prophylaxis of surgical site infection after elective inguinal hernia repair with mesh: A retrospective observational study.
The efficacy of routine antibiotic prophylaxis for prevention of surgical site infection (SSI) after elective inguinal hernia repair with a mesh patch remains uncertain. The authors of a recent Cochrane meta-analysis based on 17 randomized trials were unable to draw a definitive conclusion on this subject. The purpose of this study was to determine the effectiveness of prophylactic antibiotics for prevention of SSI after elective inguinal hernia repair with mesh and the risk factors for SSI. ⋯ The incidence of SSI among low-risk patients who did and did not receive preoperative antibiotic prophylaxis after elective inguinal hernia repair with mesh differed significantly, particularly among patients of advanced age, smokers and patients with a prolonged preoperative stay in the hospital.
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Eur. J. Clin. Pharmacol. · Sep 2016
Controlled Clinical TrialEffect of renal function on the pharmacokinetics of LCZ696 (sacubitril/valsartan), an angiotensin receptor neprilysin inhibitor.
LCZ696 (sacubitril/valsartan), an angiotensin receptor neprilysin inhibitor, is indicated for chronic heart failure (HF) and reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death and hospitalization for HF. Following oral administration, LCZ696 provides systemic exposure to valsartan and sacubitril (a prodrug), and its metabolite sacubitrilat (the active neprilysin inhibitor, formerly named as LBQ657), which is eliminated primarily via renal route. Since renal dysfunction is a common comorbidity in patients with HF, two open-label studies assessing the effect of mild, moderate, and severe renal impairment were conducted. ⋯ Renal dysfunction increases exposure to sacubitrilat while not impacting sacubitril and valsartan exposure. LCZ696 was generally well tolerated in patients with renal impairment.
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Eur. J. Clin. Pharmacol. · Sep 2016
Impact of age, gender and CYP2C9/2C19 genotypes on dose-adjusted steady-state serum concentrations of valproic acid-a large-scale study based on naturalistic therapeutic drug monitoring data.
Valproic acid (VPA) has an extensive interindividual pharmacokinetic variability. Published data regarding the impact of gender, age, and CYP2C9/2C19 genetics on VPA variability are conflicting, and the purpose of present study is to clarify the effect of these factors on dose-adjusted steady-state serum VPA concentration (C:D ratio) in a large, naturalistic patient material. ⋯ The present study shows that age and gender significantly influence VPA serum concentration. In order to obtain similar drug exposure, our findings suggest that older female patients would generally require 30-50 % lower dosing of VPA compared to younger males. Moreover, we conclude that CYP2C9/2C19 genotype is not relevant for variability in VPA exposure.