Clinical therapeutics
-
Clinical therapeutics · Nov 2008
Randomized Controlled Trial Multicenter StudyMilnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial.
Preclinical and clinical studies have suggested that milnacipran, a dual norepinephrine-serotonin reuptake inhibitor, may be efficacious in the treatment of fibromyalgia (FM). ⋯ In these adult patients with FM, both doses of milnacipran (100 and 200 mg/d) were associated with significant improvements in pain and other symptoms. Clinical Trials Identification Number: NCT00098124.
-
Clinical therapeutics · Nov 2008
Randomized Controlled Trial Multicenter StudySingle- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers.
There is an increasing body of evidence supporting the need for prophylactic management of the adverse events (AEs) associated with long-term opioid use in patients with chronic pain. Symptoms of bowel dysfunction, such as constipation, may have a significant impact on a patient's quality of life and willingness to continue opioid therapy, and therefore should be managed proactively to ensure that the patient can continue effective pain management. The fixed-dose combination (FDC) prolonged-release (PR) oxycodone/naloxone (OXN) may be an effective therapeutic approach to delivering analgesia, with a reduced risk for opioid-induced constipation. ⋯ The results from the single-dose study were consistent with the regulatory definition of bioequivalence of the FDCs and single components across the range of doses administered. The pharmacokinetic properties of the OXN FDC were similar to those of oxycodone PR + naloxone PR given as separate formulations, based on the regulatory definition. These findings were consistent with the results of the multiple-dose steady-state bioequivalence study. In this population of healthy volunteers, the pharmacokinetic properties of oxycodone apparently were not significantly influenced by administering oxycodone in a combination product, and the availability of naloxone-3-glucuronide from OXN was similar to that from the naloxone PR tablet. These findings suggest that the coadministration of oxycodone PR and naloxone PR in an FDC would not significantly affect the bioavailability of either of its constituents in these subjects.
-
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.
-
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.
-
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.