Clinical therapeutics
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Clinical therapeutics · Jan 2006
Randomized Controlled TrialPharmacokinetic and pharmacodynamic properties of multiple oral doses of sitagliptin, a dipeptidyl peptidase-IV inhibitor: a double-blind, randomized, placebo-controlled study in healthy male volunteers.
Dipeptidyl peptidase-IV (DPP-IV) inhibitors represent a new class of oral antihyperglycemic agents. Sitagliptin is an orally active and selective DPP-IV inhibitor currently in Phase III development for the treatment of type 2 diabetes mellitus. ⋯ The results from this study in a select population of healthy male volunteers suggest that multiple oral doses of sitagliptin inhibited plasma DPP-IV activity and affected active GLP-1 concentrations in a dose-dependent manner, without producing hypoglycemia. Multiple dosing of sitagliptin exhibited a PK/PD profile consistent with that of a QD regimen and was well tolerated.
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Clinical therapeutics · Jan 2006
Randomized Controlled TrialAn open-label, crossover study of the pharmacokinetics of Insoluble Drug Delivery-MicroParticle fenofibrate in combination with atorvastatin, simvastatin, and extended-release niacin in healthy volunteers.
Fenofibrate has been prescribed concomitantly with other lipid-lowering agents as a treatment for dyslipidemia. However, combination therapy, particularly a statin-fibrate combination, may be associated with an increased risk of myopathy, although this risk appears to be less with fenofibrate than with other fibrates. ⋯ Concomitant administration of a single dose of either atorvastatin or simvastatin had no significant effect on the pharmacokinetics of a single dose of IDD-P fenofibrate. A drug interaction between concomitantly administered single doses of IDD-P fenofibrate and ER niacin could not be ruled out.
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Clinical therapeutics · Dec 2005
Meta AnalysisEfficacy and tolerability of controlled-release paroxetine in the treatment of severe depression: post hoc analysis of pooled data from a subset of subjects in four double-blind clinical trials.
The aims of this work were to assess the efficacy and tolerability of controlled-release paroxetine (paroxetine CR) in the treatment of outpatients with severe major depressive disorder (MDD). ⋯ This post hoc analysis of pooled data suggests that paroxetine CR was effective and well tolerated in these outpatients with severe MDD.
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Clinical therapeutics · Dec 2005
Physician and patient factors associated with the prescribing of medications for sleep difficulties that are associated with high abuse potential or are expensive: an analysis of data from the National Ambulatory Medical Care Survey for 1996-2001.
This study evaluated the association between various socioeconomic and clinical factors relating to patients and physicians and the prescribing of medications that have a high abuse potential or are expensive for the treatment of sleep difficulties in a nationally representative sample of outpatient physician visits in the United States. ⋯ This study found an increased probability of female patients with sleep difficulties receiving a medication with high abuse potential in outpatient settings in the United States from 1996 through 2001. In addition, there was a possible association between the age and ethnicity of patients with insomnia/sleep difficulties and the prescribing of expensive medications for sleep difficulties.
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Clinical therapeutics · Dec 2005
A hospital perspective on the cost-effectiveness of beta-blockade for prophylaxis of atrial fibrillation after cardiothoracic surgery.
Prophylactic beta-blockade is the recommended strategy for suppressing atrial fibrillation after cardiothoracic surgery (CTS). However, beta-blockade's impact on the hospital length of stay (LOS) and other economic end points has not been adequately assessed. ⋯ At the institution studied, beta-blocker prophylaxis against POAF after CTS was associated with significantly reduced total costs compared with nonuse of beta-blocker prophylaxis. Patients who developed POAF had significantly increased LOS and total costs compared with those who did not develop POAE An adequately powered prospective, randomized, placebo-controlled trial is necessary to confirm the results of this evaluation.