Advances in therapy
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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.
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Advances in therapy · Sep 2011
ReviewInhaled antibiotic therapy for ventilator-associated tracheobronchitis and ventilator-associated pneumonia: an update.
Ventilator-associated pneumonia (VAP) remains a leading cause of morbidity and mortality in mechanically-ventilated patients in the Intensive Care Unit (ICU). Ventilator-associated tracheobronchitis (VAT) was previously believed to be an intermediate stage between colonization of the lower respiratory tract and VAP. More recent data, however, suggest that VAT may be a separate entity that increases morbidity and mortality, independently of the occurrence of VAP. ⋯ Although inhaled antibiotics alone could be effective for the treatment of VAP, the current consensus of opinion favors their role as adjuncts to systemic antimicrobial therapy for VAP. Inhaled antibiotics are increasingly employed for salvage therapy in patients with VAP due to multi-drug resistant Gram-negative bacteria. In contrast to VAP, VAT could be effectively treated with inhaled antibiotic therapy alone or in combination with systemic antimicrobials.
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Advances in therapy · Sep 2011
ReviewGouty arthritis: understanding the disease state and management options in primary care.
Acute gouty arthritis is an inflammatory response triggered by the release of monosodium urate crystal deposits into the joint space. The disease is associated with debilitating clinical symptoms and functional impairments as well as adverse economic and quality-of-life burdens. ⋯ Although generally effective, the use of currently available therapies to control gouty arthritis is challenging because many medications used to treat comorbidities can exacerbate gouty arthritis and because current agents are associated with a number of adverse events, contraindications, or both. Based on an understanding of the underlying inflammatory pathogenesis of gouty arthritis, several new agents are being developed that may provide improved efficacy.
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Advances in therapy · Jun 2011
ReviewReview and management of side effects associated with antiplatelet therapy for prevention of recurrent cerebrovascular events.
The risk of secondary events following noncardioembolic ischemic stroke or transient ischemic attack (TIA) is high and especially pronounced in the first days and weeks following the initial event; to reduce this risk, it is recommended that antiplatelet therapy be initiated immediately. Although the risk and impact of antiplatelet-associated side effects are generally far less substantial than those of secondary events, some (especially bleeding) can be severe and even life-threatening, and others may reduce adherence to antiplatelet regimens. Therefore, clinicians should implement strategies to reduce the risk of side effects and to manage those that occur. ⋯ Patients should be assessed for bleeding risk (especially gastrointestinal bleeding) before initiating antiplatelet therapy; those at elevated risk should be made aware of the signs and symptoms of bleeding events to facilitate prompt treatment. The addition of ER-DP to aspirin does not increase bleeding risk, although ER-DP is associated with risk of headache, which may be severe. The prevalence of headache drops rapidly following initiation of ER-DP, suggesting most patients are able to "push through" this side effect; for those who find headache intolerable, short-term use of a reduced-dose regimen may be helpful.
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Advances in therapy · Apr 2011
ReviewValidated tools for evaluating opioid-induced bowel dysfunction.
Adverse effects on the gastrointestinal system are problematic for pain patients receiving opioid treatment. Opioid-induced bowel dysfunction (OIBD) is often misinterpreted as constipation as this is the most frequently reported symptom of OIBD; however, it actually comprises the whole gut with symptoms such as nausea, reflux, bloating, and anorexia being very prevalent as well. ⋯ Few questionnaires specific to constipation exist, since most that are regularly used form part of general gastrointestinal investigations, which furthermore are often complicated and time consuming to complete. This article gives an overview of the different evaluation regimes for OIBD with a particular focus on the most frequently reported symptom; constipation.