Clinical therapeutics
-
Clinical therapeutics · Jun 2007
ReviewAdvancing therapy in type 2 diabetes mellitus with early, comprehensive progression from oral agents to insulin therapy.
Early and intensive glycemic control is necessary to prevent or minimize the development of microvascular and macrovascular complications in individuals with type 2 diabetes mellitus. However, many patients are unable to attain glycemic control, partly due to protracted treatment with oral antidiabetic drugs (OADs) despite inadequate control and barriers to initiating insulin therapy. Patients at different stages of disease may benefit from the early introduction of intensive glycemic control. ⋯ Based on the literature, early and persistent intensification of antidiabetic therapy is an approach that most likely will achieve optimal glycemic control in patients with type 2 diabetes and help prevent associated complications. Greater clinical experience with newer therapeutic approaches, including incretin mimetics and dipeptidyl peptidase-IV inhibitors, will provide insight into their place in the spectrum of diabetes treatments.
-
Clinical therapeutics · Jun 2007
Comparative StudyComparison of hospitalizations, emergency department visits, and costs in a historical cohort of Texas Medicaid patients with chronic obstructive pulmonary disease, by initial medication regimen.
Limited information is available on the relative outcomes and treatment costs of various pharmacotherapies for chronic obstructive pulmonary disease (COPD) in a Medicaid population. ⋯ In this historical population of Texas Medicaid beneficiaries, the combination-therapy cohort was 27% less likely to have a COPD-related event than the ipratropium cohort, 10% less likely to have any all-cause event, had similar COPD-related costs, and had reduced all-cause costs. Thus, compared with the ipratropium cohort, the combination-therapy cohort had an improvement in outcomes (based on the decreased time to a hospitalization or ED visit), with similar or decreased direct medical costs. Future research is needed in other patient groups.
-
Clinical therapeutics · May 2007
Randomized Controlled Trial Multicenter Study Comparative StudyAssessment of comparative pain relief and tolerability of SKI306X compared with celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, double-dummy, phase III, noninferiority clinical trial.
SKI306X, which consists of biologically active ingredients from Clematis mandsburica, Tricbosantbes kirilowii, and Prunella vulgaris, was developed and tested in preclinical trials in Korea. Those studies found that SKI306X was associated with an anti-inflammatory and analgesic effect, and that it can delay the destruction of cartilage in rheumatoid arthritis (RA). ⋯ The results of this study suggest that SKI306X was generally well tolerated and not inferior to celecoxib in regard to pain relief in these Korean patients with RA.
-
Clinical therapeutics · May 2007
Randomized Controlled Trial Comparative StudyComparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan.
To overcome the complicated mixing procedures required in the use of insulin formulations, premixed formulations consisting of rapid-acting and intermediate-type insulin in various mixing proportions have been developed. Biphasic insulin aspart 50 (BIAsp50) and 30 (BlAsp30) are 2 premixed formulations containing the active ingredient insulin aspart (IAsp) and consisting of a rapid-acting component soluble IAsp) and intermediate-acting component (protamine-crystallized protracted IAsp) in ratios of 50/50 and 30/70, respectively. These formulations are provided with the expectation that BIAsp30 and BIAsp50 will be beneficial for patients needing to improve their postprandial blood glucose control without changing their dietary habits and lifestyles. BIAsp30 has been widely used in medical practice, whereas BIAsp50 is being investigated in clinical trials. ⋯ In this small PK/PD study in adults with type 2 diabetes in Japan, mean C(max,IAsp) was significantly higher with BIAsp50 than with BIAsp30, and AUC(0-120 min,IAsp) and AUC(0-120 min,GIR) were higher with BIAsp50 than with BIAsp30.
-
Clinical therapeutics · May 2007
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of extended-release metformin in combination with a sulfonylurea (glyburide) to sulfonylurea monotherapy in adult patients with type 2 diabetes: a multicenter, double-blind, randomized, controlled, phase III study.
Metformin is widely used in the management of type 2 diabetes, either as monotherapy or in combination with other oral antihyperglycemic agents such as sulfonylureas and thiazolidinediones. Combination treatment with metformin and sulfonylurea in patients who failed monotherapy has been reported to be effective in maintaining glycemic control. ⋯ The combination of QD or BID treatment with MER+S was significantly more effective in lowering HbA(1c) and glucose levels than sulfonylurea monotherapy in these adult patients with type 2 diabetes. However, a significant increase in the prevalence of hypoglycemia was observed in the MER+S treatment groups compared with the sulfonylurea monotherapy group.