Clinical therapeutics
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Clinical therapeutics · Jan 2007
Randomized Controlled Trial Multicenter StudyPsychometric testing and validation of the Chronic Pain Sleep Inventory.
Patients with chronic pain often experience significant disruptions in sleep. A potential benefit of treatment aimed at pain relief is improved quality of sleep in patients with chronic pain. ⋯ CPSI items showed good construct validity, and the results support the scoring of a reliable single index from 3 of the 5 CPSI items that all attributed sleep problems to pain.
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Clinical therapeutics · Jan 2007
Randomized Controlled Trial Multicenter StudyMetabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Exenatide, an incretin mimetic for adjunctive treatment of type 2 diabetes mellitus (T2DM), reduced glycosylated hemoglobin (HbA(1c)) and weight in 30-week placebo-controlled trials. Some patients were followed up in open-label extensions to provide 'real-world' exenatide clinical experience. ⋯ In these patients with T2DM, adjunctive exenatide treatment for 2 years was generally well tolerated and resulted in a sustained reduction of HbA(1c), progressive reduction in weight, and improvements in HOMA-B, blood pressure, and the hepatic injury biomarkers, AST and ALT.
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Clinical therapeutics · Jan 2007
Randomized Controlled Trial Multicenter StudyDuloxetine for the management of diabetic peripheral neuropathic pain: evidence-based findings from post hoc analysis of three multicenter, randomized, double-blind, placebo-controlled, parallel-group studies.
This post hoc analysis was aimed to summarize the efficacy and tolerability of duloxetine as represented by number needed to treat (NNT) and number needed to harm (NNH) to provide a clinically useful assessment of the position of duloxetine among current agents used to treat diabetic peripheral neuropathic pain (DPNP). ⋯ These post hoc results suggest that duloxetine was effective and well tolerated for the management of DPNP and further support the importance of duloxetine as a treatment option for clinicians and patients to assist with the management of DPNP.
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Clinical therapeutics · Jan 2007
Randomized Controlled Trial Comparative StudyA randomized, double-blind, 8-week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain.
The purpose of this study was to evaluate the efficacy of controlled-release (CR) tramadol and immediate-release (IR) tramadol in patients with moderate or greater intensity chronic noncancer pain. ⋯ This study reports significant improvement in pain intensity with CR tramadol as compared with IR tramadol.
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Clinical therapeutics · Jan 2007
Randomized Controlled Trial Comparative StudyA randomized, open-label, two-period, crossover bioavailability study of two oral formulations of tacrolimus in healthy Korean adults.
Tacrolimus is a macrolide immunosuppressant used in transplantation. It has been shown to have a comparable therapeutic effect and a low adverse drug reaction profile relative to cyclosporme. ⋯ In these healthy Korean adults, there were no statistically significant differences between the pharmacokinetic parameters of the more recently developed oral formulation of tacrolimus and the conventional formulation.