Expert review of clinical pharmacology
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Expert Rev Clin Pharmacol · Jan 2013
Fentanyl pectin nasal spray: a novel intranasal delivery method for the treatment of breakthrough cancer pain.
Fentanyl pectin nasal spray is a novel intranasal formulation for the management of breakthrough cancer pain in patients taking and tolerant to opioids for persistent cancer pain. The pectin-based delivery modulates the product's transmucosal absorption. Nasal delivery allows fentanyl pectin nasal spray to achieve a greater maximum plasma concentration than oral transmucosal fentanyl products and at a much faster rate. ⋯ Throughout all phases of clinical studies, it was shown to be safe and effective in doses between 100 and 800 µg per breakthrough pain episode. Fentanyl pectin nasal spray is the only proprietary intranasal fentanyl formulation in the USA and one of two in Europe. Owing to the medication's delivery system, the pharmacokinetics and subsequent dosing are unique to this product and should not be interchanged with any other proprietary or compounded fentanyl product.
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Expert Rev Clin Pharmacol · Nov 2012
ReviewBiomarkers as predictors of outcome after cardiac arrest.
Cardiac arrest (CA) is a major health and economic problem. Management of patients resuscitated from CA is challenging for clinicians, and the mortality rate of those who achieve return of spontaneous circulation remains high. Hypoxic brain injury, cardiovascular abnormalities and systemic ischemia/reperfusion response characterize the so-called 'postcardiac arrest syndrome', which could lead to multiple organ failure and poor outcome after CA. ⋯ A number of factors are thought to influence the prognosis of patients after CA, but due to the heterogeneity of CA population and scenarios no single factor has been identified as a reliable predictor of outcome and the timing and optimal approach to prognostication is still controversial. Biomarkers represent a growing area of interest in this field, as they may provide clinicians with early information on the severity of organ dysfunction to make a decision on clinical strategies and prognosticate outcome. In this article, the authors will focus on cardiac, neurological and inflammatory biomarkers as potential predictors of outcome after CA.
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Teriflunomide, the active metabolite of an approved antirheumatic drug, is an emerging oral therapy for multiple sclerosis (MS). Next to the inhibition of pyrimidine biosynthesis and proliferation of activated lymphocytes, it seems to have multiple anti-inflammatory and immunomodulating effects. ⋯ While multiple other studies with teriflunomide are currently ongoing, its exact place in future treatment algorithms for MS is difficult to predict. It may be a good alternative for patients wishing to have an oral treatment with relatively large data regarding long-term safety.
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Expert Rev Clin Pharmacol · Sep 2012
Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health.
Clinical trials in children are challenging and filled with important ethical considerations that differ from adults. Given difficulties associated with pediatric clinical trials, off-label prescribing is a common practice in pediatrics, which can lead to adverse safety events and efficacy failures. To overcome these consequences, in the past 15 years, legislation in the USA and Europe has provided incentives to industry and increased government funding to conduct pediatric trials. ⋯ Standards for Research (StaR) in Child Health, begun in 2009, aims to improve the design, conduct and reporting of pediatric trials. This organization uses a consensus guideline approach involving academic, government and industry stakeholders to identify and disseminate best practices for pediatric trials. Six out of 11 planned standards are currently published.
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Expert Rev Clin Pharmacol · Jul 2012
ReviewPredicting ICU admission in community-acquired pneumonia: clinical scores and biomarkers.
Community-acquired pneumonia (CAP) remains a common and serious worldwide health problem. Despite all the advances in therapy, significant interest has focused on the identification of patients with CAP who require intensive care unit admission to improve their outcomes. The severity assessment of CAP provides an important guide to clinicians in deciding the site of care and the use of empiric antibiotics and adjuvant therapy. ⋯ An objective scoring system with a high level of sensitivity and specificity to predict the severity of CAP and the need for high levels of care do not exist. Today, the addition of clinical scores and biomarkers to clinical judgment is the best approach to optimize the care of severe CAP. Future research will allow validation of these and newer tools to improve the prognosis of patients with CAP.