Advances in therapy
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Advances in therapy · May 2012
ReviewGuanfacine extended release as adjunctive therapy to psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder.
Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder associated with a wide range of impairments. Psychostimulants are generally first-line pharmacotherapy, but symptom improvement is suboptimal in some patients. In these patients, clinicians frequently use a combination of psychostimulants and nonscheduled medications to manage ADHD, although published evidence supporting this practice was relatively scarce until recently. ⋯ In a subsequent 9-week, randomized, double-blind, placebocontrolled study of subjects aged 6-17 years with suboptimal response to a long-acting, extendedrelease, oral psychostimulant, adjunctive GXR (administered in the morning or evening) was associated with significantly greater symptom reduction than placebo and psychostimulant (ADHD Rating Scale IV [ADHD-RS-IV] total score, placebo-adjusted least squares mean reductions: GXR AM, -4.5, P = 0.002; GXR PM, -5.3, P < 0.001, based on Dunnett's test). Across multiple studies, the safety and tolerability profile of GXR administered adjunctively to psychostimulants has been consistent with the known profiles of each medication. Additional studies should further explore the role of adjunctive GXR in clinical practice to help identify those patients most likely to benefit from such therapy.
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Apixaban is a highly selective, reversible, direct factor Xa inhibitor that inhibits both free factor Xa and prothrombinase activity, and clot-bound factor Xa activity. A predictable pharmacokinetic profile, multiple pathways of elimination, an improved bleeding profile relative to warfarin with a lack of other significant adverse events, and no need for routine anticoagulation monitoring make apixaban appealing. Apixaban is currently approved for venous thromboembolism (VTE) prophylaxis in total hip replacement and total knee replacement in Europe, Brazil, Australia, and New Zealand, and has been pre-approved in Indonesia and the Philippines. ⋯ In patients with acute coronary syndrome, apixaban added to dual antiplatelet therapy with aspirin and clopidogrel resulted in unacceptably high rates of major bleeding. In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin, and was associated with significantly more major bleeding events than enoxaparin. Ongoing phase 3 trials will provide data regarding the efficacy and safety of apixaban for treatment of acute deep vein thrombosis and pulmonary embolism.
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D-Dimer (DD) has been described as a useful predictor of both morphologic changes in acute thoracic aortic dissection (TAD) and of TAD-associated mortality. This study analyzed the use of DD screening to screen patients with chest pain for acute (TAD) to determine if it improves diagnosis and cost effectiveness. This study also looked at the association of DD levels with diagnoses frequently seen in patients with dyspnea or chest pain. ⋯ Owing to the low incidence of TAD, DD screening increases diagnostic efforts and costs but it remains unclear whether it would actually speed up TAD diagnosis. In a clinical setting DD did not help to discriminate other relevant diagnoses. Despite the high sensitivity of DD for aortic dissection published in the literature, the physician's clinical judgment remains paramount.
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Advances in therapy · Nov 2011
ReviewOseltamivir in seasonal, pandemic, and avian influenza: a comprehensive review of 10-years clinical experience.
Oseltamivir (Tamiflu®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) is an orally administered antiviral for the treatment and prevention of influenza A and B infections that is registered in more than 100 countries worldwide. More than 83 million patients have been exposed to the product since its introduction. ⋯ The implications of changes in susceptibility of circulating influenza viruses to oseltamivir and other antiviral agents are also described, as is the emergence of antiviral resistance during and after the 2009 pandemic. The fourth main section deals with the safety profile of oseltamivir in standard and special patient populations, and reviews spontaneously reported adverse event data from the pandemic and pre-pandemic periods and the topical issue of neuropsychiatric adverse events. Finally, the article considers the pharmacoeconomics of oseltamivir in comparison with vaccination and usual care regimens, and as a component of pandemic influenza mitigation strategies.
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Advances in therapy · Oct 2011
Review Historical ArticleUnapproved drugs in the United States and the Food and Drug Administration.
Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. ⋯ In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs-Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.