European journal of clinical pharmacology
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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. · Oct 2016
ReviewPrevention of selective outcome reporting: let us start from the beginning.
Healthcare professionals and patients could be negatively influenced in their judgments by articles and meta-analyses presenting selective outcome reporting. Clinical trials should be transparent from inception to the publication of results. To this end, trial prospective registration is an ethical and scientific requirement that have shown to be effective in preventing selective reporting of outcomes. However, even journals with a clear pre-registration policy publish trial results that were retrospectively registered. ⋯ Retrospective registration of trials may foster selective outcome reporting unless journal editors implement specific quality control processes aiming to prevent or minimize this type of bias. Prospective registration of trials-and protocol public disclosure if proven effective in future studies-prevents outcome reporting bias, a must to ensure clinicians and patients have access to reliable clinical trial results. Journal editors should enforce, rather than encourage, appropriate measures to ensure publication of trials free of outcome reporting bias.
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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
Polypharmacy and medication regimen complexity as factors associated with staff informant rated quality of life in residents of aged care facilities: a cross-sectional study.
The purpose of this study is to investigate the association between polypharmacy with health-related quality of life (HRQoL) and medication regimen complexity with HRQoL in residential aged care facilities (RACFs). ⋯ These findings suggest that polypharmacy and medication regimen complexity are not associated with staff informant rated HRQoL. Further research is needed to investigate how specific medication classes may impact change in quality of life over time.
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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.