Clinical therapeutics
-
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.
-
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.
-
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.
-
Clinical therapeutics · Jan 2007
Randomized Controlled TrialPost hoc analysis of a randomized, double-blind, placebo-controlled efficacy and tolerability study of tramadol extended release for the treatment of osteoarthritis pain in geriatric patients.
Once-daily tramadol extended release (ER) was evaluated for 12 weeks in a randomized, double-blind, placebo-controlled, parallel-group study in 1020 patients with osteoarthritis of the knee or hip. As previously reported, compared with placebo, the results of the study showed that patients treated with tramadol ER had significant improvement in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and in pain-related sleep parameters. ⋯ This post hoc analysis suggests that the tramadol ER 300-mg dose was associated with statistically significant improvement in pain intensity and physical function, and for most of the pain-related sleep effects among these geriatric patients with moderate chronic/persistent pain.
-
Clinical therapeutics · Jan 2007
Randomized Controlled TrialResults of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes.
This study evaluated the glycosylated hemoglobin (HbA(1c)-lowering effect of colesevelam hydrochloride, a bile acid sequestrant, in subjects with type 2 diabetes that was inadequately controlled by existing antihyperglycemic therapy. ⋯ In these subjects with type 2 diabetes, 12 weeks of colesevelam treatment were associated with significant reductions in HbA(1c) and in fructosamine and postprandial glucose levels compared with placebo. The 2 groups had a similar adverse-event profile, with the exception of an increased incidence of constipation in the colesevelam group. These results suggest that colesevelam may improve both lipid control and glycemic control in patients with type 2 diabetes receiving oral antihyperglycemic medications.