Clinical therapeutics
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Clinical therapeutics · Aug 2009
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of the efficacy and safety of arformoterol 15 microg twice daily and arformoterol 30 microg once daily in COPD: a single-dose, multicenter, randomized, modified-blind, two-way crossover study.
The aim of this study was to compare the efficacy and safety of nebulized arformoterol 15 microg/2 mL twice daily (ARF15 BID) and 30 microg/4 mL once daily (ARF30 QD) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD). ⋯ In these subjects with moderate to severe COPD, single-day administrations of ARF15 BID or ARF30 QD were associated with FEV(1) responses over a period of 24 hours that were considered equivalent per the protocol definition employed in the present study. FEV1 improvement over 12 hours was greater for ARF30 QD after the morning dose and for ARF15 BID after the evening dose. ClinicalTrials.gov Identifier: NCT00571428.
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Clinical therapeutics · Aug 2009
Randomized Controlled TrialPharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteers.
Gabapentin enacarbil is an actively transported prodrug of gabapentin that provides predictable dose-proportional gabapentin exposure with high (> or =68%) oral bioavailability. ⋯ Gabapentin enacarbil was associated with dose-proportional gabapentin exposure at doses up to 6000 mg and was generally well tolerated in these healthy subjects. These findings support the use of 6000-mg gabapentin enacarbil in a definitive QT/QTc study.
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Clinical therapeutics · Aug 2009
Randomized Controlled TrialNeutralization of alpha(2)-antiplasmin by microplasmin: a randomized, double-blind, placebo-controlled, ascending-dose study in healthy male volunteers.
Microplasmin is the isolated proteinase domain of plasmin. Administration of microplasmin has been found to neutralize alpha(2)-antiplasmin (alpha(2)-AP) activity, which has been associated with reduced infarct size in various preclinical models of stroke. ⋯ Neutralization of alpha(2)-AP activity by microplasmin was feasible in these healthy male volunteers. The urticarial reactions observed in the highest dose groups were considered dose-limiting adverse events. Further trials are needed to investigate the tolerability of this therapy and whether it is neuroprotective in patients with acute ischemic stroke.
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Clinical therapeutics · Aug 2009
Multicenter StudyLong-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials.
Short-term treatment with the meth-ylphenidate transdermal system (MTS) has been well tolerated in several clinical trials in children with attention-deficit/hyperactivity disorder (ADHD). However, the effects of long-term use have not been systematically evaluated. ⋯ Slightly less than half (48.0%) of subjects completed this 12-month, open-label extension study of MTS. Most AEs were mild to moderate in severity and, with the exception of application-site reactions, were typical of those previously observed with methylphenidate. ClinicalTrials.gov identifier: NCT00151957.
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Clinical therapeutics · Aug 2009
ReviewLevocetirizine for the treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children.
Levocetirizine (LCZ) is a second-generation antihistamine that was approved in January 2008 for the relief of symptoms of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) in adults and children aged > or = 6 years. ⋯ In the studies reviewed, LCZ 5 mg/d was effective in reducing symptoms of PAR, SAR, and CIU and improving QoL, with an acceptable tolerabili-ty profile. There is a need for studies of longer durations, head-to-head comparisons against other anti-histamines, drug-interaction studies, safety studies in infants, and cost-effectiveness analyses.