Clinical therapeutics
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Clinical therapeutics · Jan 2012
Randomized Controlled Trial Comparative StudyAssessment of the efficacy and safety profiles of aspirin and acetaminophen with codeine: results from 2 randomized, controlled trials in individuals with tension-type headache and postoperative dental pain.
Aspirin is a widely used NSAID that has been extensively studied in numerous conditions. Nonprescription analgesics, such as aspirin, are frequently used for a wide variety of common ailments, including conditions such as dental pain and tension-type headache. ⋯ These 2 randomized, double-blind, placebo-controlled studies demonstrate that treatment with aspirin (1000 mg) provides statistically significant analgesic efficacy compared with placebo use and comparable efficacy with acetaminophen (300 mg) with codeine (30 mg) therapy after impacted third molar extraction and in tension- type headache.
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Clinical therapeutics · Jan 2012
Randomized Controlled TrialPharmacokinetics of vandetanib: three phase I studies in healthy subjects.
Vandetanib is an orally available inhibitor of vascular endothelial growth factor receptor 2 and epidermal growth factor receptor and is rearranged during transfection tyrosine kinase activity. Development has included studies in non-small cell lung cancer and other tumor types. Accurate elimination kinetics were not determined in patient studies, and so the current human volunteer studies were performed to derive detailed kinetic data. ⋯ The pharmacokinetics of vandetanib after single oral doses to healthy subjects were defined and the metabolic pathway was proposed. Vandetanib was absorbed and eliminated slowly with a t(½) of ∼10 days after single oral doses. The extent of absorption was not significantly affected by the presence of food. Approximately two thirds of the dose was recovered in feces (44%) and urine (25%) over 21 days. Unchanged vandetanib and N-desmethyl and N-oxide metabolites were detected in plasma, urine, and feces. Vandetanib appeared to be was well tolerated in the populations studied.
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Clinical therapeutics · Jan 2012
Multicenter StudyClinical pharmacokinetics of gabapentin after administration of gabapentin enacarbil extended-release tablets in patients with varying degrees of renal function using data from an open-label, single-dose pharmacokinetic study.
Gabapentin enacarbil, a transported acyloxyalkylcarbamate prodrug of gabapentin, provides predictable and dose-proportional gabapentin exposure (AUC). Gabapentin is cleared via renal excretion, and its elimination is proportional to creatinine clearance (CrCL); CrCL can, therefore, be used as a predictor of gabapentin renal clearance. Gabapentin produced from hydrolysis of gabapentin enacarbil is also eliminated via the renal clearance pathway. It was, therefore, anticipated that the pharmacokinetics of gabapentin derived from gabapentin enacarbil would also be affected by renal function. ⋯ The data suggest that dosage adjustment for gabapentin enacarbil is necessary in patients with impaired renal function. Gabapentin enacarbil, 600 mg, seemed to be well tolerated in this small selected population.
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Clinical therapeutics · Jan 2012
Multicenter StudyIncidence of nephrotoxicity and association with vancomycin use in intensive care unit patients with pneumonia: retrospective analysis of the IMPACT-HAP Database.
The 2005 guidelines from the American Thoracic Society and the Infectious Diseases Society of America recommend vancomycin trough levels of 15 to 20 mg/L for the therapy of hospital-acquired (HAP), ventilator-associated (VAP), and health care-associated (HCAP) pneumonia. ⋯ Nephrotoxicity may be common among intensive care unit patients with pneumonia treated with broad-spectrum antibiotic therapy that includes vancomycin. The finding that an initial vancomycin trough level ≥15 mg/L may be an independent risk factor for nephrotoxicity highlights the need for additional studies to assess current recommendations for vancomycin dosing for ICU patients with pneumonia.
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Clinical therapeutics · Jan 2012
ReviewEstradiol valerate/dienogest: a novel combined oral contraceptive.
Estradiol valerate/dienogest (E2V/DNG) is a combined oral contraceptive (COC) with 2 new hormonal entities and a unique 4-phasic dosing regimen indicated for women to prevent pregnancy. ⋯ Estradiol valerate/dienogest is a new contraceptive formulation. It offers efficacy, tolerability, and an acceptable safety profile with a potentially better bleeding pattern than levonorgestrel-containing COCs. This COC may be especially useful for older women of reproductive age who are adherent to therapy and looking for shorter and/or lighter menstrual cycles. Studies will need to be performed to determine whether clinically significant differences in outcomes exist among E2V/DNG and other available COCs.