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 · Dec 2006
Randomized Controlled Trial Multicenter StudyTramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial.
This study evaluated the efficacy and tolerability of tramadol 37.5-mg/acetaminophen 325-mg combination tablets (tramadoUAPAP) as add-on therapy in subjects with rheumatoid arthritis (RA) pain that was inadequately controlled by NSAIDs and disease-modifying antirheumatic drugs alone. ⋯ In this study, tramadol/APAP used as add-on therapy in subjects with symptomatic RA was associated with a significant improvement in pain relief and a significant reduction in pain intensity compared with placebo, with no improvement in physical function. Use of tramadol/APAP may be considered when analgesics are needed in addition to conventional NSAIDs and disease-modifying antirheumatic drugs in subjects with RA.
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Clinical therapeutics · Nov 2006
Multicenter Study Clinical TrialSymptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT).
Most clinical trials designed to evaluate overactive bladder (OAB) syndrome treatments have focused on measuring micturition variables from bladder diaries. However, although diaries help physicians assess symptoms objectively, they lack information on patients' subjective experience of OAB symptoms and the effects of treatment. ⋯ Flexibly dosed solifenacin 5 and 10 mg QD was associated with reductions in patient-reported OAB symptom bother and improvements in patients' perception of bladder condition and HRQOL.