Current medical research and opinion
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To evaluate the long-term dosing, safety, and tolerability of fentanyl buccal tablet (FBT) in a large cohort of opioid-tolerant patients with chronic noncancer pain and breakthrough pain (BTP). ⋯ Despite the limitations, including the controlled clinical setting, this pooled analysis of several clinical studies provides valuable information for the long-term management of BTP with FBT. Patients require regular evaluation and, when necessary, adjustment of opioid medications to maintain adequate pain control. FBT was generally safe and well tolerated in this setting.
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To examine the impact of medication choice between duloxetine or pregabalin on medication adherence and direct healthcare costs among patients with diabetic peripheral neuropathic pain (DPNP). ⋯ Commercially-insured DPNP patients initiating duloxetine had significantly higher medication adherence and lower healthcare costs than those initiating pregabalin.
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Multicenter Study
Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain.
Breakthrough cancer pain (BTcP) is a transient exacerbation of cancer pain in patients with otherwise stable, persistent background pain. This study evaluated the long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet (sublingual fentanyl ODT), for the treatment of BTcP in opioid-tolerant patients with cancer. ⋯ Sublingual fentanyl ODT was effective and well tolerated for the long-term treatment of BTcP in opioid-tolerant cancer patients. There was an increase in satisfaction with pain medication during the study, and sublingual fentanyl ODT showed an acceptable safety profile over 12 months of treatment.
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Most of the literature on informed consent in pharmaceutical drug research works on the assumption that informed consent is something that is homogeneous and thus can be rendered procedurally universal. This may be justifiable to a certain extent owing to the fact these are all drug trials anyway. Nevertheless, in spite of this general similarity, we also know that the clinical drug development phases are characteristically different, and that phase IV is very different from the other phases because, owing to its postmarketing nature, it is much more varied in scope and in type. ⋯ We shall deal with the issues on the necessity of informed consent for this type of research and then discuss the possibilities for an opt-out system. We conclude that informed consent is necessary for non-interventional studies, and thus any form of waiving of rights of participants to informed consent must have a valid substantial justification. The distinct character of phase IV accounts for the difference in content of the informed consent document compared to that of earlier phases, and both opt-in and opt-out procedures are ethically justifiable as long as the participant's participation remains informed and voluntary.
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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.