Int J Clin Pharm Th
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Int J Clin Pharm Th · Aug 2012
Randomized Controlled TrialSugammadex is not associated with QT/QTc prolongation: methodology aspects of an intravenous moxifloxacin-controlled thorough QT study.
Sugammadex is a novel γ-cyclodextrin and the first selective relaxant binding agent to be developed for the reversal of rocuronium and vecuroniuminduced neuromuscular blockade. According to International Conference on Harmonization (ICH) E14, a thorough QT/QTc study is required for most new compounds to assess the potential to cause QT prolongation, because a delay in cardiac repolarization may create an electrophysiological environment that favors the development of cardiac arrhythmias, most notably Torsade de Pointes. Therefore a thorough QTc study was conducted to evaluate the effect of sugammadex on the individually corrected QTc interval (QTcI). ⋯ Single therapeutic (4 mg/kg) and supra-therapeutic (32 mg/kg) intravenous doses of sugammadex are not associated with clinically important QTc prolongation.
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Int J Clin Pharm Th · Jun 2012
Randomized Controlled TrialPharmacokinetics of a new diclofenac sodium formulation developed for subcutaneous and intramuscular administration.
To assess the relative bioavailability of diclofenac sodium hydroxypropyl β-cyclodextrin (HPβCD) administered via the subcutaneous (s.c.) and intramuscular (i.m.) route versus Voltaren® i.m. and to evaluate the dose linearity and pharmacokinetics of the s.c. formulation at three dose levels. Safety and local tolerability were also assessed. ⋯ Bioequivalence of diclofenac HPβCD 75 mg/ml after s.c. and i.m. administration with Voltaren® i.m. was demonstrated, except for the marginal deviation in Cmax when comparing the i.m. test and Voltaren®. Linearity was also demonstrated for the three doses intended for marketing.
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Int J Clin Pharm Th · Apr 2012
Comparative StudyCost comparison of outpatient treatment with granulocyte colony-stimulating factors (G-CSF) in Germany.
Granulocyte colony-stimulating factors (G-CSF), are available for prevention of neutropenia and reduction of its complications in cytostatic chemotherapy. The purpose of this analysis was to determine the consumption rates for various G-CSF and to compare outpatient medication costs per patient and treatment cycle. ⋯ Treatment with the original preparation lenograstim is significantly cheaper compared to the other two original drugs and biosimilar. The costs of G-CSF treatment with the original preparation lenograstim and the filgrastim biosimilars are in a similar range, but with a significantly lower cost for lenograstim. Compared to their reference product the biosimilars thus show a cost advantage.
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Int J Clin Pharm Th · Jan 2012
Randomized Controlled Trial Comparative StudyTCI remifentanil vs. TCI propofol for awake fiber-optic intubation with limited topical anesthesia.
The purpose of this study was to compare the effects of propofol and remifentanil target-controlled infusion (TCI) on awake fiber-optic intubation with limited local anesthesia. 36 patients requiring fiberoptic intubation were randomized to receive propofol (P) or remifentanil (R) effect-site TCI. Target concentrations, sedation levels, pulse oximetry, hemodynamic change, duration, number of adjustments, intubating conditions and recall after surgery were recorded at each stage. The results showed that the target intubation concentration of remifentanil was very close to the sedation concentration but that the intubation concentration of propofol was more than double its sedation concentration (5.83±1.46 μg/ml vs. 2.60±0.47 μg/ml, respectively). ⋯ More adjustments and a longer duration were required in propofol-treated patients. Recall was significantly more frequent in remifentanil-treated patients. We concluded that compared to TCI propofol, TCI remifentanil can provide safer and better intubating conditions for fiber-optic intubation with limited local anesthesia.
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Int J Clin Pharm Th · Dec 2011
Randomized Controlled TrialAnalgesic efficacy with rapidly absorbed ibuprofen sodium dihydrate in postsurgical dental pain: results from the randomized QUIKK trial.
To evaluate the onset of analgesic effect for a new formulation of ibuprofen sodium dihydrate versus conventional ibuprofen (ibuprofen acid). ⋯ Ibuprofen sodium dihydrate was as effective as conventional ibuprofen, but had a faster onset of initial pain relief and significantly reduced pain intensity within the first 30 minutes after administration, providing rapid clinically meaningful pain relief for patients.