Clinical therapeutics
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Clinical therapeutics · Nov 2008
Randomized Controlled Trial Multicenter Study Comparative StudyA 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes.
This trial compared the efficacy and safety profiles of the insulin analogues detemir and glargine as the basal insulin component of a basal-bolus regimen in patients with type 2 diabetes mellitus (T2DM) who were being treated with oral antidiabetic drugs (OADs) or insulin with or without OADs. ⋯ when used as indicated as part of a basal-bolus regimen in patients with T2DM who had previously received other insulin and/or OAD regimens, detemir was noninferior to glargine in its effects on overall glycemic control. Both basal insulins were associated with clinically relevant reductions in hyperglycemia. Both were well tolerated, with no significant difference in the frequency of hypoglycemia or AEs.
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Clinical therapeutics · Nov 2008
Randomized Controlled Trial Comparative StudyComparison of propofol, droperidol, and metoclopramide for prophylaxis of postoperative nausea and vomiting after breast cancer surgery: a prospective, randomized, double-blind, placebo-controlled study in Japanese patients.
Breast cancer surgery performed with the patient under general anesthesia has been associated with a relatively high incidence of postoperative nausea and vomiting (PONV). Between 60% and 80% of patients who undergo mastectomy (with axillary dissection) experience PONV. We previously reported that propofol at a subhypnotic dose of 0.5 mg/kg was more effective than placebo in preventing PONV in women who undergo mastectomy. ⋯ The prevalences of PONV were not significantly different between propofol 0.5 mg/kg and droperidol 20 microg/kg 0 to 24 hours after anesthesia in this small, select group of Japanese women who underwent breast cancer surgery. The prevalences of PONV were significantly lower with propofol and droperidol compared with metoclopramide 0.2 mg/kg and placebo.
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Clinical therapeutics · Nov 2008
ReviewNilotinib: a second-generation tyrosine kinase inhibitor for the treatment of chronic myelogenous leukemia.
Nilotinib, a second-generation tyrosine kinase inhibitor (TKI) formerly known as AMN107, was approved by the US Food and Drug Administration (FDA) on October 29, 2007, for the treatment of adult patients with chronic-phase (CP) and accelerated-phase (AP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) resistant to or intolerant of prior treatment that included imatinib. ⋯ Nilotinib is an oral second-generation bcr-abl TKI indicated for the treatment of imatinib resistant or -intolerant Ph+ CML-CP and -AP in adults. Positive clinical activity and tolerability have been reported in clinical trials. Clinical data on off-label indications and in patients with Ph+ ALL and GIST continue to emerge.
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Clinical therapeutics · Nov 2008
Randomized Controlled TrialA 16-week, randomized, double-blind, placebo-controlled, crossover trial to quantify the combined effect of an angiotensin-converting enzyme inhibitor and a beta-blocker on blood pressure reduction.
Although beta-blockers and angiotensin-converting enzyme (ACE) inhibitors are often used together, there is a lack of quantitative evidence for the efficacy of this combination in reducing blood pressure (BP). ⋯ The combination of the beta-blocker atenolol 25 mg plus the ACE inhibitor lisinopril 5 mg was associated with a significantly greater decrease in BP compared with either alone. The BP reduction with the combination treatment was similar to and statistically consistent with the 2 drugs having additive effects. Clinical Trials Identification Number: ISRCTN97280940.
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Clinical therapeutics · Nov 2008
Randomized Controlled TrialBioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: a single-dose, randomized, open-label, crossover study.
Levothyroxine has a narrow therapeutic index; therefore, precise and accurate assessment of the bioequivalence of different levothyroxine products is critical. Bioavailability estimates of levothyroxine formulations might be affected by baseline concentrations of the hormone. ⋯ The results of this study suggest that the test formulation was bioequivalent to the reference formulation of levothyroxine in these healthy volunteers, according to the US FDA definition of bioequivalence. This was supported by the analysis of concentration-time profiles without and with correction for basal endogenous levothyroxine.