Clinical therapeutics
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Clinical therapeutics · Jul 2008
In vitro stability, potency, and dissolution of duloxetine enteric-coated pellets after exposure to applesauce, apple juice, and chocolate pudding.
Difficulty swallowing is a common problem in the clinical setting, particularly in elderly patients, and can significantly affect an individual's ability to maintain a proper level of nutrition. ⋯ Results from this study found that the enteric coating of duloxetine pellets mixed with applesauce or apple juice was not negatively affected. The pellets were stable at room temperature for < or = 2 hours and should quantitatively allow delivery of the full capsule dose, provided that the pellet integrity is maintained (ie, not crushed, chewed, or otherwise broken). Therefore, mixing duloxetine pellets with applesauce or apple juice appears to be an acceptable vehicle for administration. However, exposing the pellets to chocolate pudding damaged the pellets' enteric coating, suggesting that pudding may be an unacceptable vehicle for administration.
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Clinical therapeutics · Jul 2008
In vitro stability of lyophilized and reconstituted recombinant activated factor VII formulated for storage at room temperature.
Recombinant activated factor VII (rFVIIa) is indicated to treat bleeding episodes or prevent bleeding related to surgery in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The first-generation rFVIIa formulation is stable when stored under refrigeration. A new formulation has been developed for storage at room temperature, which may improve patients' access to treatment during bleeding episodes. ⋯ In these in vitro experiments, the new lyophilized formulation of rFVIIa was stable when stored for 24 months at 25 degrees C, 12 months at 30 degrees C, 6 months at 40 degrees C, and 12 hours at 50 degrees C and 60 degrees C without compromise to its activity or rFVIIa content. The reconstituted product retained activity when stored at 25 degrees C for 6 hours and at 5 degrees C for 24 hours.
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Clinical therapeutics · Jun 2008
Randomized Controlled Trial Multicenter Study Comparative StudyTolerability and safety profile of 12- to 28-week treatment with interferon beta-1b 250 and 500 microg QOD in patients with relapsing-remitting multiple sclerosis: a multicenter, randomized, double-blind, parallel-group pilot study.
It is not known whether the currently available treatment regimen of interferon beta-1b (IFNbeta-1b) 250 microg provides the maximum benefit possible in the treatment of relapsing-remitting multiple sclerosis (RRMS), or whether higher doses of IFNbeta-1b will prove to be more beneficial. ⋯ IFNbeta-1b 500 microg administered SC QOD was generally well tolerated in these patients with RRMS. Large, randomized controlled studies are needed to determine if there are significant differences in MRI end points between the 250- and 500-microg doses.
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Clinical therapeutics · Jun 2008
Randomized Controlled Trial Multicenter Study Comparative StudyA 52-week, randomized, open-label, parallel-group comparison of the tolerability and effects of pitavastatin and atorvastatin on high-density lipoprotein cholesterol levels and glucose metabolism in Japanese patients with elevated levels of low-density lipoprotein cholesterol and glucose intolerance.
Statin therapy has been found to produce substantial reductions in low-density lipoprotein cholesterol (LDL-C) levels, resulting in a reduced risk for cardiovascular events. Recently, research interest has focused on modification of high-density lipoprotein cholesterol (HDL-C) levels for the potential prevention of cardiovascular events. The effects of pitavastatin and atorvastatin on HDL-C have not been directly compared. ⋯ In these patients with elevated LDL-C levels and glucose intolerance, 52 weeks of treatment with pitavastatin 2 mg/d was associated with significantly greater increases in HDL-C and Apo A-I levels than atorvastatin 10 mg/d. Both treatments were well tolerated.
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Clinical therapeutics · Jun 2008
Randomized Controlled Trial Comparative StudyEfficacy of combination intravenous lidocaine and dexamethasone on propofol injection pain: a randomized, double-blind, prospective study in adult Korean surgical patients.
Pain on injection is a common adverse effect with propofol used for general anesthesia. ⋯ Combination lidocaine 20 mg and dexamethasone 6 mg, with venous occlusion for 1 minute, was more effective than lidocaine 20 mg or dexamethasone 6 mg alone for pain control during propofol injection in these Korean patients.