Journal of clinical pharmacy and therapeutics
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In vitro companion diagnostic devices (CDx) provide information on pharmacogenomic biomarkers (PGBMs) to enable the safe and effective use of targeted agents for personalized therapy. These devices require specific regulations that strike a balance between scientific evidence and financial burden. The aims were to compare approval of PGBMs and CDx in the USA and Japan and to help inform current discussions on personalized medicine. ⋯ Our study confirms that there is still a substantial gap in the approval of PGBMs and CDx between Japan and the USA. Complementary coverage of unapproved CDx by the National Health Insurance, however, is raising access to a similar level in both countries. Because the number of expensive personalized medicines and CDx is increasing, patient access will continue to be an important challenge to healthcare systems in all countries.
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The prevailing theory regarding Alzheimer disease (AD) is that insoluble amyloid β-peptide (Aβ) plays a critical role in the cortical plaques characteristic of the disease. Because Aβ is formed from the sequential splicing of amyloid precursor protein (APP) catalysed by 'secretase' enzymes (α, β and γ), clinical trials of secretase inhibitors will either result in beneficial pharmacotherapy or, if negative, cast doubt on the role of Aβ in AD. With recent clinical trial failures, is the Aβ theory wrong? ⋯ The failures of secretase inhibitors in clinical trials appear to bring into question the long-hypothesized association between AD and Aβ production. However, the disease might have been too advanced in these patients to benefit from this type of therapy (mainly preventive). Secretase inhibitors are still being studied, along with new diagnostic tools, with the hope of testing patients earlier, that is, with less advanced disease. If these trials also fail, the prevailing view of the role of Aβ in AD will truly be in doubt.
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In an effort to provide guidance for the use of analgesics for pain management--while at the same time acknowledging the professional, patient and regulatory-legal concerns about the use of strong opioids--the World Health Organization (WHO) in 1986 suggested a conservative stepwise approach. In addition to the use of non-pharmacologic measures, the WHO recommended that pharmacotherapy be initiated using a non-opioid analgesic first and then progress through 'weak' opioids or analgesic combinations to 'strong' opioids if, and only if, needed. This approach gave a rationale, and a justification if necessary, for the use of opioids. This stepwise approach became widely known as the WHO analgesic 'ladder'. ⋯ Because of the evolving understanding of the physiology of pain and better approaches to its management, we suggest that more modern best practice is an analgesic 'pyramid'.
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Baking soda is a common household product promoted by the manufacturer as an antacid. It contains sodium bicarbonate and has the potential for significant toxicity when ingested in excessive amounts. Characterizing the patterns and outcomes from the misuse of baking soda as a home remedy can guide the clinical assessment and preventative counselling of patients at risk for use of this product. ⋯ Misuse of baking soda can result in serious electrolyte and acid/base imbalances. Patients at highest risk of toxicity may include those who chronically use an antacid, those who use the method to 'beat' urine drug screens, pregnant women and young children. Self-treatment with baking soda as a home remedy may also mask or delay medical care thereby complicating or exacerbating an existing medical problem. We suggest that healthcare providers counsel high-risk patients about the potential complications of misuse of baking soda as a home remedy.
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Randomized Controlled Trial
Effects of food on the pharmacokinetics of ponatinib in healthy subjects.
Ponatinib is a potent oral tyrosine kinase inhibitor with activity against BCR-ABL, the primary driver of chronic myeloid leukaemia and Philadelphia chromosome-positive acute lymphoblastic leukaemia. This single-centre, single-dose, randomized, open-label, three-period crossover study evaluated the pharmacokinetics and bioavailability of a single oral dose of ponatinib (45-mg tablet) under fasting conditions and following consumption of high- and low-fat meals by healthy subjects. ⋯ Food does not affect the single-dose pharmacokinetics of ponatinib. These data demonstrate that ponatinib may be administered with or without food.