Current medical research and opinion
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Practice Guideline
Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the clinical development of both biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). In the last few years, several new products have been developed or are in development for the treatment of RA, which offer significant efficacy with regard to disease control, including prevention of structural damage and disability. Concurrently, novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. ⋯ Accordingly, several new EULAR/ACR recommendations have been or are being developed. Several important additions and changes are needed in the 2003 guidance to incorporate the current scientific knowledge into clinical trial design for the development of future products. Under the auspices of the Group for the Respect of Ethics and Excellence in Science (GREES), a group of experts in the field of RA and clinical trial design met to provide a consensus recommendation for an update to the 2003 EMA guidance document.
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Long-term pain is a debilitating condition that is costly to treat and has a significant impact on patient quality of life. Classical opioids have been used for the treatment of pain for centuries and are one of the most effective drug classes available for acute severe pain and long-term pain. However, concerns regarding adverse effects, tolerance to analgesic effects and the potential for addiction have resulted in a reluctance to prescribe and use opioids for the management of long-term non-cancer pain. Adverse events, including gastrointestinal side effects such as constipation, nausea and vomiting, and central nervous system side effects such as sedation are responsible for as many as one in five patients discontinuing opioid treatment, often leading to inadequate pain relief and poor patient quality of life. Therefore, new analgesic therapies are needed that are associated with fewer adverse effects, whilst providing sustainable pain relief for patients with long-term pain. ⋯ Despite these recent advances, there have been very few completely novel drug developments. Hence, there remains a continuing need for innovative therapeutic strategies for the treatment of long-term pain. The most promising alternatives appear to be the use of traditional opioids together with peripheral opioid antagonists, combining opioids with glial cell modulators, and the use of novel agents with µ-receptor agonist and noradrenaline reuptake inhibitor activity within the same molecule (MOR-NRI compounds).
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Review Meta Analysis
A clinical and economic evaluation of enteral nutrition.
The American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines advise use of enteral nutrition (EN) for critically ill hospital patients requiring nutritional support, but no studies have comprehensively estimated economic benefits from adherence to this recommendation. ⋯ The evidence of both clinical and economic gains from EN is consistent with ASPEN guidelines recommending use of EN in critically ill hospital patients when possible.
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The major objectives of the CHANGE PAIN International Advisory Board are to enhance understanding of chronic pain and to develop strategies for improving pain management. At its second meeting, in November 2009, evidence was presented that around one person in five in Europe and the USA experiences chronic pain, and the delay before referral to a pain specialist is often several years. Moreover, physicians' pharmacological approach to chronic pain is inconsistent, as evidenced by the huge variation in treatment between different European countries. ⋯ The 11-point NRS enables the patient to rate the current pain intensity and to set a realistic individual target level. On the reverse are six key parameters affecting the patient's quality of life; clinicians simply need to agree with patients whether improvement is needed in each one. Regular use can establish the efficacy and tolerability of pain management, and the rate of progress towards individual treatment targets.