Clinical therapeutics
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Clinical therapeutics · Dec 2008
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults.
Cyclooxygenase-2 (COX-2) selective inhibitors and nonselective NSAIDs are commonly used to treat osteoarthritis (OA) of the knee. ⋯ Statistically significant differences in effectiveness and tolerability were not found between these 2 treatments in these patients with OA knee pain.
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Clinical therapeutics · Dec 2008
Randomized Controlled TrialIntuitiveness, instruction time, and patient acceptance of a prefilled insulin delivery device and a reusable insulin delivery device in a randomized, open-label, crossover handling study in patients with type 2 diabetes.
Because the use of insulin therapy can place a substantial burden on patients with diabetes, insulin administration should be as simple as possible. ⋯ In this study, when all handling steps were included, the FP device was associated with significantly greater intuitiveness and a shorter injection time compared with the HL device. Further research is needed to determine whether these differences between devices are clinically meaningful.
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Clinical therapeutics · Dec 2008
Randomized Controlled Trial Comparative StudyBioequivalence and comparison of pharmacokinetic properties of 4-mg tablet formulations of rosiglitazone hydrochloride and rosiglitazone maleate: a single-dose, randomized, open-label, two-period crossover study in healthy adult male Chinese volunteers.
Rosiglitazone is an insulin-sensitizing oral thiazolidinedione used for treating patients with type 2 diabetes mellitus. There are 9 oral generic and branded formulations of rosiglitazone available in the People's Republic of China (PRC); however, a literature search did not identify any published data concerning the bioavailability of these formulations in the Chinese population. ⋯ In this small study in these healthy adult male Chinese volunteers, a single 4-mg dose of rosiglitazone hydrochloride appeared to be bioequivalent to rosiglitazone maleate, according to the regulatory definition, based on the rate and extent of absorption. Both formulations were well tolerated.
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Clinical therapeutics · Dec 2008
Randomized Controlled Trial Multicenter Study Comparative StudyComparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study.
The major beneficial effect of statins- reducing the risk for coronary events-has primarily been ascribed to reductions in low-density lipoprotein cholesterol (LDL-C) but may in part be related to a direct antiinflammatory action (ie, decreased high-sensitivity C-reactive protein [hs-CRP] concentration). ⋯ In these patients with documented CAD, evidence of low-grade inflammation, and normal range lipid profiles, the effects of atorvastatin on changes in hs-CRP were dose dependent, with the high dose (80 mg) being associated with significantly greater reductions in hs-CRP concentrations. Both doses were associated with a significant and progressive decline in hs-CRP largely independent of changes in LDL-C, HDL-C, and TG. Clinical Trials Identification Number: NCT00163202.
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Clinical therapeutics · Dec 2008
Randomized Controlled TrialPharmacokinetics of 8-hour intravenous infusion of NXY-059: a phase I, randomized, double-blind (within dose panels), placebo-controlled study in healthy Chinese volunteers.
NXY-059 is a free radical-trapping neuroprotectant that has been reported to reduce infarct size and preserve brain function in experimental models of acute ischemic stroke. NXY-059 administered as an 8- or 72-hour IV infusion has been reported to be well tolerated in healthy young (age, 20-45 years) and older (55-75 years) white volunteers. NXY-059 is no longer in development following a lack of efficacy found in a Phase III trial in patients with acute ischemic stroke. ⋯ The results from the present study suggest that the PK properties of NXY-059 were similar in the Chinese and historical white healthy volunteer populations.