Clinical therapeutics
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Clinical therapeutics · Dec 2008
Randomized Controlled TrialPharmacokinetics of 8-hour intravenous infusion of NXY-059: a phase I, randomized, double-blind (within dose panels), placebo-controlled study in healthy Chinese volunteers.
NXY-059 is a free radical-trapping neuroprotectant that has been reported to reduce infarct size and preserve brain function in experimental models of acute ischemic stroke. NXY-059 administered as an 8- or 72-hour IV infusion has been reported to be well tolerated in healthy young (age, 20-45 years) and older (55-75 years) white volunteers. NXY-059 is no longer in development following a lack of efficacy found in a Phase III trial in patients with acute ischemic stroke. ⋯ The results from the present study suggest that the PK properties of NXY-059 were similar in the Chinese and historical white healthy volunteer populations.
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Clinical therapeutics · Dec 2008
Comparative StudyOral versus injectable antipsychotic treatment in early psychosis: post hoc comparison of two studies.
Few studies have compared long-acting injectable second-generation antipsychotics with oral antipsychotics. Long-acting injectable antipsychotics-developed specifically to address the problem of adherence-might have an important role to play in treating early psychosis. ⋯ The findings of this post hoc analysis suggest that there were advantages in terms of efficacy, fewer extrapyramidal symptoms, and more weight gain with long-acting injectable second-generation antipsychotics as compared with oral antipsychotic treatment in early-episode psychosis.
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Clinical therapeutics · Dec 2008
Multicenter StudyA US multicenter, retrospective, observational study of erythropoiesis-stimulating agent utilization in anemic, critically ill patients admitted to the intensive care unit.
Anemia is a common comorbid condition among patients admitted to the intensive care unit (ICU). Darbepoietin alfa and epoetin alfa are erythropoiesis-stimulating agents (ESAs) used to manage anemia in the ICU, although neither drug has an indication in critically ill patients. ⋯ Based on these results, it is apparent that the practice patterns associated with ESA treatment of critically ill patients admitted to the ICU between February 2005 and September 2005 were highly variable.
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Clinical therapeutics · Dec 2008
Randomized Controlled Trial Comparative StudyBioequivalence and comparison of pharmacokinetic properties of 4-mg tablet formulations of rosiglitazone hydrochloride and rosiglitazone maleate: a single-dose, randomized, open-label, two-period crossover study in healthy adult male Chinese volunteers.
Rosiglitazone is an insulin-sensitizing oral thiazolidinedione used for treating patients with type 2 diabetes mellitus. There are 9 oral generic and branded formulations of rosiglitazone available in the People's Republic of China (PRC); however, a literature search did not identify any published data concerning the bioavailability of these formulations in the Chinese population. ⋯ In this small study in these healthy adult male Chinese volunteers, a single 4-mg dose of rosiglitazone hydrochloride appeared to be bioequivalent to rosiglitazone maleate, according to the regulatory definition, based on the rate and extent of absorption. Both formulations were well tolerated.
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Clinical therapeutics · Dec 2008
Randomized Controlled TrialIntuitiveness, instruction time, and patient acceptance of a prefilled insulin delivery device and a reusable insulin delivery device in a randomized, open-label, crossover handling study in patients with type 2 diabetes.
Because the use of insulin therapy can place a substantial burden on patients with diabetes, insulin administration should be as simple as possible. ⋯ In this study, when all handling steps were included, the FP device was associated with significantly greater intuitiveness and a shorter injection time compared with the HL device. Further research is needed to determine whether these differences between devices are clinically meaningful.