Clinical therapeutics
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Clinical therapeutics · Nov 2008
ReviewNilotinib: a second-generation tyrosine kinase inhibitor for the treatment of chronic myelogenous leukemia.
Nilotinib, a second-generation tyrosine kinase inhibitor (TKI) formerly known as AMN107, was approved by the US Food and Drug Administration (FDA) on October 29, 2007, for the treatment of adult patients with chronic-phase (CP) and accelerated-phase (AP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) resistant to or intolerant of prior treatment that included imatinib. ⋯ Nilotinib is an oral second-generation bcr-abl TKI indicated for the treatment of imatinib resistant or -intolerant Ph+ CML-CP and -AP in adults. Positive clinical activity and tolerability have been reported in clinical trials. Clinical data on off-label indications and in patients with Ph+ ALL and GIST continue to emerge.
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Clinical therapeutics · Nov 2008
Randomized Controlled TrialBioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: a single-dose, randomized, open-label, crossover study.
Levothyroxine has a narrow therapeutic index; therefore, precise and accurate assessment of the bioequivalence of different levothyroxine products is critical. Bioavailability estimates of levothyroxine formulations might be affected by baseline concentrations of the hormone. ⋯ The results of this study suggest that the test formulation was bioequivalent to the reference formulation of levothyroxine in these healthy volunteers, according to the US FDA definition of bioequivalence. This was supported by the analysis of concentration-time profiles without and with correction for basal endogenous levothyroxine.
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Clinical therapeutics · Nov 2008
Long-term persistence with statin treatment in a not-for-profit health maintenance organization: a population-based retrospective cohort study in Israel.
Although discontinuing lipid-lowering treatment can cause preventable morbidity, previously published reports have indicated considerable variability in persistence with statin use. In general, such reports have been limited by short follow-up periods and modest study populations. ⋯ In this study in these patients receiving first-time statin treatment in Israel, we found poor persistence with statins among both the primary- and secondary-prevention cohorts, especially among new immigrants and patients with low SES despite low out-of-pocket prescription costs and free access to health services.
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The 2007 European Union (EU) regulation on medicinal products for pediatric use may change the present unsatisfying situation in the EU by stimulating research and development of medicines for use in children through rewards and incentives. ⋯ Similar to the research in pediatric drug formulations that was stimulated by the US legislation and incentives of the last decade, the 2007 EU legislation promises improvements in the availability of child-appropriate drugs in Europe.
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Clinical therapeutics · Nov 2008
Stability of doripenem in vitro in representative infusion solutions and infusion bags.
Doripenem, a new parenteral carbapenem with broad-spectrum antibacterial activity, is indicated for the treatment of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis. According to the US prescribing information, the carbapenems imipenem and meropenem are stable in sodium chloride for 4 hours. ⋯ Doripenem 5 mg/mL was stable for up to 12 hours in vitro in 0.9% sodium chloride at room temperature. Therefore, doripenem can be constituted, mixed with infusion fluids in the pharmacy, stored, delivered, and infused into a patient within a time frame suitable for 4-hour extended infusions.