Clinical therapeutics
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Clinical therapeutics · Aug 2005
Randomized Controlled Trial Multicenter StudyMuraglitazar, a dual (alpha/gamma) PPAR activator: a randomized, double-blind, placebo-controlled, 24-week monotherapy trial in adult patients with type 2 diabetes.
Peroxisome proliferator-activated receptors (PPARs) present a therapeutic target, and simultaneous activation of PPAR-alpha and PPAR-gamma may provide improvements in glycemic control and dyslipidemia in patients with type 2 diabetes. ⋯ In this study, 24 weeks of treatment with muraglitazar 2.5 or 5 mg was an effective treatment option for these patients with type 2 diabetes whose disease was inadequately controlled with diet and exercise.
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Clinical therapeutics · Aug 2005
Review Meta AnalysisCardiovascular safety of lumiracoxib: a meta-analysis of all randomized controlled trials > or =1 week and up to 1 year in duration of patients with osteoarthritis and rheumatoid arthritis.
The cardiovascular (CV) safety of non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitors has been the subject of considerable debate. ⋯ This meta-analysis of 34,668 patients receiving > or =1 week and up to 1 year of treatment found no evidence that lumiracoxib was associated with a significant increase in CV risk compared with naproxen, placebo, or all comparators (placebo, diclofenac, ibuprofen, celecoxib, rofecoxib, and naproxen).
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Clinical therapeutics · Aug 2005
Randomized Controlled Trial Multicenter StudyTreatment of symptomatic diabetic peripheral neuropathy with the protein kinase C beta-inhibitor ruboxistaurin mesylate during a 1-year, randomized, placebo-controlled, double-blind clinical trial.
The aim of this study was to assess the effects of ruboxistaurin (RBX) mesylate on nerve function and sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). ⋯ RBX appeared to be well tolerated in the patients with DPN who participated in this study. Overall, changes in VDT and NTSS-6 total scores did not differ among treatment groups at end point. However, RBX treatment appeared to be of benefit for the subgroup of patients with less severe symptomatic DPN by relieving sensory symptoms and improving nerve fiber function, as indicated by reductions in VDT and NTSS-6 total score.
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Clinical therapeutics · Aug 2005
Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy.
The aim of this study was to develop and validate a neuropathy sensory symptom scale, the Neuropathy Total Symptom Score-6 (NTSS-6), which evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN) in clinical trials, with the intent of distinguishing a response to therapy. ⋯ The NTSS-6 provided a valid assessment of neuropathy sensory symptoms in this sample of patients with DM and DPN, which suggests that it may be useful for symptom evaluation in clinical trials and practice. The NTSS-6 showed internal consistency, test-retest reliability, and construct validity. There was also convergent validity of the scores, indicating that the NTSS-6 may be a suitable questionnaire for clinical trials that evaluate symptoms of DPN in this well-defined patient population.